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Published Proposals

Access to clinical trial data provides opportunities to conduct further research that can help advance medical science or improve patient care. This helps ensure the data provided by research participants are used to maximum effect in the creation of knowledge and understanding.

Proposal Number Sponsor/Funder Title Lead researcher Affiliation Publication(s)
631 GSK Predictors of BPH Progression Dr. Stephen Freedland, MD Duke UniversityDurham, North CarolinaUSA https://cancerpreventionresearch.aacrjournals.org/content/early/2017/04/27/1940-6207.CAPR-17-0019

https://cancerpreventionresearch.aacrjournals.org/content/early/2015/01/31/1940-6207.CAPR-14-0260

https://doi.org/10.1016/j.juro.2017.08.108
https://doi.org/10.18632/oncotarget.10690

https://dx.doi.org/10.1016/j.eururo.2015.12.002
http://dx.doi.org/10.1016/j.juro.2017.04.075

https://doi.org/10.1002/pros.23041
647 GSK Assessing and Reporting Heterogeneity of Treatment Effect in Randomized Clinical Trials David M. Kent, MD, MSc Institute for Clinical Research and Health Policy Studies, Tufts Medical CentBoston, MAUSA Kent DM, Nelson J, Dahabreh IJ, Rothwell PM, Altman DG, Hayward RA. Risk and treatment effect heterogeneity: re-analysis of individual participant data from 32 large clinical trials. Int J Epidemiol. 2016 Jul 3. pii: dyw118. [Epub ahead of print] PMID: 27375287

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5841614/
651 GSK Descriptive evaluation of SAE reporting rates in vaccine clinical trials among Latin American children. Thomas Verstraeten P95 Pharmacovigilance and Epidemiology ServicesLeuven, BE Baay M, Bollaerts K, Struchiner C, Verstraeten T. Background rates of disease in Latin American children from a rotavirus vaccine study. Hum Vaccin Immunother. 2017 Apr 25:1-5. doi: 10.1080/21645515.2017.1320007. PMID: 28441094

https://www.tandfonline.com/doi/full/10.1080/21645515.2017.1320007

657 GSK Use of Heparins in patients with Cancer: Individual patient-data meta-analysis of randomized trials Holger Schunemann, MD, MSc, PhD McMaster University Schunemann, H. J., Ventresca, M., Crowther, M., Briel, M., Zhou, Q., Noble, S., Macbeth, F., Griffiths, G., Garcia, D., Lyman, G. H., Di Nisio, M., Iorio, A., Mbuagbaw, L., Neumann, I., van Es, N., Brouwers, M., Guyatt, G., Streiff, M. B., Marcucci, M., Baldeh, T., Florez, I. D., Alma, O. G., Solh, Z., Bossuyt, P. M., Kahale, L. A., Ageno, W., Bozas, G., Buller, H. R., Lebeau, B., Lecumberri, R., Loprinzi, C., McBane, R., Sideras, K., Maraveyas, A., Pelzer, U., Perry, J., Klerk, C., Agnelli, G., Akl, E. A. Evaluating prophylactic heparin in ambulatory patients with solid tumours: a systematic review and individual participant data meta-analysis. Lancet Haematol. 2020;7(10):e746-e755.
https://doi.org/10.1016/S2352-3026(20)30293-3

van Es N, Ventresca M, Di Nisio M, Zhou, Q., Noble, S., Crowther, M., Briel, M., Garcia, D., Lyman, G. H., Macbeth, F., Griffiths, G., Iorio, A., Mbuagbaw, L., Neumann, I., Brozek, J., Guyatt, G., Streiff, M. B., Baldeh, T., Florez, I. D., Gurunlu Alma, O., Agnelli, G., Ageno, W., Marcucci, M., Bozas, G., Zulian, G., Maraveyas, A., Lebeau, B., Lecumberri, R., Sideras, K., Loprinzi, C., McBane, R., Pelzer, U., Riess, H., Solh, Z., Perry, J., Kahale, L. A., Bossuyt, P. M., Klerk, C., Buller, H. R., Akl, E. A., Schunemann, H. J. IPDMA Heparin Use in Cancer Patients Research Group. The Khorana score for prediction of venous thromboembolism in cancer patients: An individual patient data meta-analysis. J Thromb Haemost. 2020;18(8):1940-1951. Submit February 26, 2020
https://onlinelibrary.wiley.com/doi/epdf/10.1111/jth.14824
668 GSK Associations between antihypertensive drugs and patterns of blood pressure changes: a strategy to reduce the burden of anti-VEGF induced hypertension Arduino A Mangoni Flinders University, School of MedicineAdelaide, AU M.J.Sorich, A.Rowland, G.Kichenadasse, R.J.Woodman, A.A. Mangoni. British Journal of Cancer volume 114, pages1313-1317 (2016). Risk factors of proteinuria in renal cell carcinoma patients treated with VEGF inhibitors: a secondary analysis of pooled clinical trial data.
DOI: 10.1038/bjc.2016.147
669 GSK A multi-center, double-blind, placebo controlled study of paroxetine and imipramine in adolescents with unipolar major depression - efficacy and adverse outcomes. Jon Jureidini University of Adelaide Le Noury J, Nardo JM, Healy D, et al. Restoring Study 329: efficacy and harms of paroxetine and imipramine in treatment of major depression in adolescence. BMJ 2015;351:h4320.

https://www.bmj.com/content/351/bmj.h4320

674 GSK Antiepileptic drug monotherapy for epilepsy: an overview of systematic reviews andnetwork meta-analysis Antony Marson University of Liverpool https://doi.org/10.1136/bmj.j1390

https://www.cochranelibrary.com/cdsr/doi/10.1002/14651858.CD011412.pub3/full
675 Novartis Validation study on magnitude of tumorshrinkage as a prognostic marker Viktor Grünwald Medical School HannoverHannover, Germany V. Grünwald, M. Dietrich, G.R. Pond. 2016 Annals of Oncology 27(suppl_6). 817P - Prognostic ability of HR-QoL parameters in metastatic renal cell carcinoma (mRCC).
DOI:10.1093/annonc/mdw373.44

M.J.Sorich, A.Rowland, G.Kichenadasse, R.J.Woodman, A.A.Mangoni. British Journal of Cancer volume 114, pages 1313-1317 (2016). Risk factors of proteinuria in renal cell carcinoma patients treated with VEGF inhibitors: a secondary analysis of pooled clinical trial data.
DOI: 10.1038/bjc.2016.147
911 GSK Outcome Measures in Systemic Lupus Erythematosus: Constructing a Meaningful Response Index from Existing Clinical Trial Data Lindsy Forbess, MD, MSc Cedars-Sinai Medical CenterLos Angeles, CAUS Failure of a systemic lupus erythematosus response index developed from clinical trial data: lessons examined and learned. Forbess LJ, Bresee C, Wallace DJ, Weisman MH. Lupus. 2017 Jan 1:961203317692433. doi: 10.1177/0961203317692433. [Epub ahead of print] PMID: 28173737

https://journals.sagepub.com/doi/10.1177/0961203317692433

930 GSK MASTERMIND: Stratification of glycaemic response the ADOPT and RECORD studies Professor Andrew Hattersley, M.D. FRS University of Exeter Medical SchoolExeter, UK John M. Dennis, William E. Henley, Michael N. Weedon, Mike Lonergan, Lauren R. Rodgers, Angus G. Jones, William T. Hamilton, Naveed Sattar, Salim Janmohamed, Rury R. Holman, Ewan R. Pearson, Beverley M. Shields, Andrew T. Hattersley
Diabetes Care Sep 2018, 41 (9) 1844-1853; DOI: 10.2337/dc18-0344
https://doi.org/10.2337/dc18-0344

Rodgers LR, Dennis JM, Shields BM, et al. Prior event rate ratio adjustment produced estimates consistent with randomized trial: a diabetes case study. J Clin Epidemiol. 2020;122:78-86. doi:10.1016/j.jclinepi.2020.03.007
https://pubmed.ncbi.nlm.nih.gov/32194148/


Dennis JM, Shields BM, Henley WE, Jones AG, Hattersley AT. Disease progression and treatment response in data-driven subgroups of type 2 diabetes compared with models based on simple clinical features: an analysis using clinical trial data. Lancet Diabetes Endocrinol. 2019;7(6):442-451.
DOI:https://doi.org/10.1016/S2213-8587(19)30087-7

Donnelly LA, Dennis JM, Coleman RL, et al. Risk of Anemia With Metformin Use in Type 2 Diabetes: A MASTERMIND Study [published online ahead of print, 2020 Aug 14]. Diabetes Care. 2020;dc201104. doi:10.2337/dc20-1104
https://pubmed.ncbi.nlm.nih.gov/32801130/

945 ViiV THE CD4/CD8 RATIO AS A PREDICTOR OF NON-AIDS EVENTS DURING ANTIRRETROVIRAL THERAPY: CONFIRMATION OF ITS PREDICTIVE VALUE AND IMPACT OF MARAVIROC IN TREATMENT-EXPERIENCED PATIENTS Santiago Moreno University Hospital Ramón y CajalMadrid, Spain Serrano-Villar S, Caruana G, Zlotnik A, Pérez-Molina JA, Moreno S. Effects of Maraviroc versus Efavirenz in Combination with Zidovudine-Lamivudine on the CD4/CD8 Ratio in Treatment-Naive HIV-Infected Individuals. Antimicrobial Agents and Chemotherapy. 2017; 61(12). doi: 10.1128/AAC.01763-17.PMID: 28993335.
https://aac.asm.org/content/61/12/e01763-17.full

946 GSK, Novartis, Roche Assessing models for changes in tumour size over time and how they relate to survival times. Raluca Eftimie Division of Mathematics, University of DundeeDundee, UK Mistry, H.B., Orrell, D. & Eftimie, R. Model based analysis of the heterogeneity in the tumour size dynamics differentiates vemurafenib, dabrafenib and trametinib in metastatic melanoma. Cancer Chemother Pharmacol 81, 325-332 (2018).

https://doi.org/10.1007/s00280-017-3486-3
951 GSK Optimized Eltrombopag Treatment of Hepatitis C virus-related thrombocytopenia Mohammad Saleh The University of JordanAmman, JO M.I.Saleh, S.Bani Melhim, H.M. Al-Ramadhani, S.Alzubiedi. Eur J Drug Metab Pharmacokinet 2019 Feb;44(1):31-42. Bayesian Population Pharmacokinetic Modeling of Eltrombopag in Chronic Hepatitis C Patients.
DOI: 10.1007/s13318-018-0490-x
977 GSK The implication of central adjudication of COPD exacerbations by experts for treatment effect estimates and sample size calculation Milo Puhan University of ZurichZurich, CH Bias away from the null due to miscounted outcomes? A case study on the TORCH trial
Stefanie Muff, Milo A Puhan, Leonhard Held
January 1, 2017

https://doi.org/10.1177/0962280217694403
993 GSK A Spirometric Z-Score Based Reappraisal of the TORCH Study(GSK-SCO30003): Salmeterol and Fluticasone Propionate in COPD. Carlos A. Vaz Fragoso, MD Yale University School of Medicine https://www.tandfonline.com/doi/abs/10.1080/15412555.2018.1424815
998 GSK Determination of minimally important difference for short form 36 and Facit Fatigue for Systemic lupus erythematosus Meenakshi Jolly, MD, MSCP Rush University Medical CenterChicago, ILUSA Devilliers H, Annapureddy N, Jolly M. Minimal Clinically Important Differences for Generic Patient Reported Outcomes Tools in SLE [abstract]. Arthritis Rheumatol. 2016; 68 (suppl 10).

https://acrabstracts.org/abstract/minimal-clinically-important-differences-for-generic-patient-reported-outcomes-tools-in-sle/
1000 GSK Review of fever and febrile convulsion rates in children after trivalent influenza vaccine. Dr Jean Li-Kim-Moy, MBBS, FRACP National Centre for Immunisation Research and SurveillanceThe Children's Hospital at WestmeadSydney, AU Li-Kim-Moy, Jean, Wood, Nicholas, Jones, Cheryl, Macartney, Kristine, and Booy, Robert. (2018), Impact of fever and antipyretic use on influenza vaccine immune responses in children. 10.1097/INF.0000000000001949

https://journals.lww.com/pidj/Fulltext/2018/10000/Impact_of_Fever_and_Antipyretic_Use_on_Influenza.3.aspx

1016 GSK Statistical methods for estimating the duration of protection of malaria vaccines: secondary analysis of data from the RTSS/AS02A trial in Mozambique. Paul Milligan London School of Hygiene and Tropical MedicineLondon, UK https://doi.org/10.1016/j.vaccine.2020.05.086
Yin Bun Cheung, Xiangmei Ma, K.F. Lam, Paul Milligan,
Estimation of the primary, secondary and composite effects of malaria vaccines using data on multiple clinical malaria episodes,
Vaccine, Volume 38, Issue 32, 2020, p. 4964-4969
1028 ViiV Impact of dolutegravir on CD4+/CD8+ ratio and CD4+ percentage in HIV-infected naive patients. José Ramón Blanco Hospital San Pedro - Center for Biomedical Research of La Rioja (CIBIR), SPAIN https://doi.org/10.1016/j.cmi.2017.11.016
1053 GSK Validation of the spirometric LMS equations in the Spanish population Dr. Patricia Sobradillo Universitary Hospital of ArabaVitoria, Spain Validacion de las ecuaciones espirometricas LMS en la poblacion espanola: Estudio VALEMOS. P.Sobradillo, E.Marquez, M.Barrecheguren, F.J.Callejas, J.L.Garcia Rivero, B.Abascal, L.Puente, M.Calle Sessión: 71Área: EPOC
https://www.separcontenidos.es/posters/index.php?frameInferior=publicaciones_detalles&ID_Normativa=12&Admin=1&Idioma=Esp&ID_MenuPublicaciones=6455
1058 ViiV Ritonavir-boosted protease inhibitor-based versus non-nucleoside reverse transcriptase inhibitor-based highly active antiretroviral therapy regimens: a systematic review and individual patient data me Alvaro H Borges Centre for Health & Infectious Diseases ResearchRigshospitalet, University of CopenhagenCHIP, Department of Infectious Diseases and Rheumatology,Section 2100, FinsencentretBlegdamsvej 9DK-2100 Copenhagen ØDenmark https://doi.org/10.1093/cid/ciw236
1071 Boehringer Ingelheim, GSK Optimising the Analysis of vascular Prevention trials (OA-Prevention) Lisa Woodhouse University of Nottingham Woodhouse, L.J., Montgomery, A.A., Mant, J. et al. Statistical reanalysis of vascular event outcomes in primary and secondary vascular prevention trials. BMC Med Res Methodol 21, 218 (2021). https://doi.org/10.1186/s12874-021-01388-6
1078 Lilly Nocebo effects in the treatment of bipolar disorder: Results from an individual study participant level meta-analysis of the placebo arm of olanzapine clinical trials Seetal Dodd Barwon Health Dodd S, Walker AJ, Brnabic AJM, Hong N, Burns A, Berk M. Incidence and characteristics of the nocebo response from meta-analyses of the placebo arms of clinical trials of olanzapine for bipolar disorder.
Bipolar Disord. 2018;00:1-9.

https://doi.org/10.1111/bdi.12662

1079 ViiV The effects of maraviroc versus efavirenz in combination with zidovudine/abacavir on the CD4/CD8 ratio in treatment-naïve HIV-infected individuals. Sergio Serrano-Villar, MD PhD Deparment of Infectious DiseasesUniversity Hospital Ramón y CajalMadrid, Spain. Serrano-Villar S, Caruana G, Zlotnik A, Pérez-Molina JA, Moreno S. Effects of Maraviroc versus Efavirenz in Combination with Zidovudine-Lamivudine on the CD4/CD8 Ratio in Treatment-Naive HIV-Infected Individuals. Antimicrobial Agents and Chemotherapy. 2017; 61(12). doi: 10.1128/AAC.01763-17.PMID: 28993335.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5700350/


1084 GSK Studies on the relationship between corticosteroids and unfavorable medical effects. A study based on the BLISS-52 and BLISS-76 clinical trials. Ronald van Vollenhoven, MD, PhD Karolinska InstituteDepartment of MedicineStockholm, Sweden "Relationship between glucocorticoid dose and adverse events in systemic lupus erythematosus: data from a randomized clinical trial."
DOI:10.1080/03009742.2017.1336570

https://www.tandfonline.com/doi/abs/10.1080/03009742.2017.1336570

1088 GSK A study to identify risk factors that modify Rotarix efficacy and influence the time to rotavirus gastroenteritis among vaccinated and unvaccinated African infants. Joann Gruber University of North Carolina at Chapel Hill Gruber JF, Becker-Dreps S, Hudgens MG, Brookhart MA, Thomas JC, Jonsson Funk
M. Timing and predictors of severe rotavirus gastroenteritis among
unvaccinated infants in low- and middle-income countries. Epidemiol Infect
2018;146(6):698-704.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5895523/

Gruber JF, Becker-Dreps S, Hudgens MG, Brookhart MA, Thomas JC, Jonsson Funk
M. Timing of Rotavirus Vaccine Doses and Severe Rotavirus Gastroenteritis
among Vaccinated Infants in Low- and Middle-Income Countries. Epidemiology
2018.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6167161/

1090 GSK Validating the test-negative case-control design for estimating rotavirus vaccine effectiveness using gold-standard randomized controlled trial data from South Africa and Malawi (Rota-037) M. Elizabeth Halloran Fred Hutchinson Cancer Research Center; Department of Biostatistics, University of Washington http://dx.doi.org/10.1016/j.vaccine.2016.10.077
1100 Boehringer Ingelheim Systolic blood pressure level and risk of intracerebral hemorrhage. Jacoba P Greving Julius Center for Health Sciences and Primary Care UMC Utrecht http://www.neurology.org/content/88/2/177.full.html
1103 GSK A study on the possible association between antidepressant response to SSRIs and proneness for side effects Elias Eriksson, MD, PhD University of GothenburgGothenburg, Sweden https://doi.org/10.1038/mp.2017.147
1136 Takeda Can Machine Learning Algorithms using General Labs Predict Clinical Remission and Mucosal Healing for Patients on Vedolizumab? Peter Higgins University of Michigan https://onlinelibrary.wiley.com/doi/epdf/10.1111/apt.14510
1137 GSK Immunotherapy trial simulators: Using mathematical, computational and statistical techniques to simulate trial design for new products in the treatment, vaccination and immunoprophylaxis of disease. Roy Anderson, PhD Imperial College LondonLondonUK Cite this article: Hadjichrysanthou C, Caue¨t E,
Lawrence E, Vegvari C, de Wolf F, Anderson
RM. 2016 Understanding the within-host
dynamics of influenza A virus: from theory
to clinical implications. J. R. Soc. Interface 13:
20160289.
http://dx.doi.org/10.1098/rsif.2016.0289
1140 Boehringer Ingelheim Evaluation of the effect of incidental beta blocker use on clinical response to the EGFR TKI, afatinib John Heymach, MD, PhD MD Anderson Cancer Center https://clinicalstudydatarequest.com/Approved-Requests-DataSharingAgreement-Published.aspx
1141 GSK Multivariate methods for meta-analysis of vaccine studies with multiple correlated outcomes Merryn Voysey Nuffield Department of Primary Care Health Sciences, University of Oxford http://jamanetwork.com/journals/jamapediatrics/fullarticle/2627571
1148 Lilly Meta-analysis of the risk of relapse in bipolar disorder Dr. Joaquim Radua FIDMAG Germanes Hospitalàries & King’s College London Radua et al. Meta-analysis of the risk of subsequent mood episodes in bipolar disorder. Psychotherapy and Psychosomatics, in Press. DOI: 10.1159/000449417
1154 GSK Developing New Outcome Measures for SLE by Deconvoluting Available Datasets Peter E. Lipsky, MD Lupus Research InstituteNew York, NYUSA https://onlinelibrary.wiley.com/doi/full/10.1002/art.40522
1173 GSK, Lilly Initial severity and antidepressant efficacy for anxiety disorders: an individual patient data meta-analysis Ymkje Anna de Vries Interdisciplinary Center Psychopathology and Emotion regulation, Department of Psychiatry, University Medical Center Groningen, the Netherlands https://doi.org/10.1002/da.22737
1224 GSK INTERACTION BETWEEN MENINGOCOCCAL SEROGROUP B VACCINE (BEXSERO™) AND ROUTINE INFANT VACCINES ON THE RISK OF OCCURRENCE AND RECURRENCE OF ADVERSE EVENTS FOLLOWING IMMUNIZATION. Gaston De Serres Institut National de Santé Publique du Québec(INSPQ)andLaval University http://dx.doi.org/10.1136/bmjopen-2018-026953
1257 GSK An independent evaluation of the cardiovascular risk of rosiglitazone: meta-analysis of GSK’s publicly available clinical trial data Joseph S. Ross, MD, MHS Yale University School of MedicineYale-New Haven Hospital Center for Outcomes Research and Evaluation https://doi.org/10.1136/bmj.l7078
1292 Lilly Applications of Item Response Theory to Clinical ADHD Research: Analysis of the ADHDRS-IV and Modeling Response to Treatments and Item-Level Treatment Sensitivity Alex Sturm University of California, Los Angeles Sturm, A., McCracken, J. T., & Cai, L. (2017). Evaluating the Hierarchical Structure of ADHD Symptoms and Invariance Across Age and Gender. Assessment. 2017 Jun 1:1073191117714559. doi: 10.1177/1073191117714559.
1320 GSK Utility of a measure of Lupus Low Disease Activity State in SLE Pei Xuan Ong (Emily) Monash Health https://ard.bmj.com/content/early/2019/01/24/annrheumdis-2018-214427
1321 GSK Bone Quality Project Dennis M. Black University of California, San Francisco Treatment-Related Changes in Bone Turnover and Fracture Risk Reduction in Clinical Trials of Anti-Resorptive Drugs: A Meta-Regression Douglas C Bauer, Dennis M Black, Mary L Bouxsein, Li-Yung Lui, Jane A Cauley, Anne E de Papp, Andreas Grauer, Sundeep Khosla, Charles E McCulloch, and Richard Eastell for the Foundation for the National Institutes of Health (FNIH) Bone Quality Project
Journal of Bone and Mineral Research, Vol. 33, No. 4, April 2018, pp 634-642
DOI: 10.1002/jbmr.3355
Treatment-related changes in bone mineral density as a surrogate biomarker for fracture risk reduction: metaregression analyses of individual patient data from multiple randomised controlled trials Dennis M Black, Douglas C Bauer, Eric Vittinghoff, Li-Yung Lui, Andreas Grauer, Fernando Marin, Sundeep Khosla, Anne de Papp, Bruce Mitlak, Jane A Cauley, Charles E McCulloch, Richard Eastell, Mary L Bouxsein, for the Foundation for the National Institutes of Health Bone Quality
Project Lancet Diabetes Endocrinol 2020; 8: 672-82
doi: 10.1016/S2213-8587(20)30159-5
Change in Bone Density and Reduction in Fracture Risk: A Meta-Regression of Published Trials Mary L Bouxsein, Richard Eastell, Li-Yung Lui, Lucy A Wu, Anne E de Papp, Andreas Grauer, Fernando Marin, Jane A Cauley, Douglas C Bauer, and Dennis M Black; for the FNIH Bone Quality Project Journal of Bone and Mineral Research, Vol. 33, No. xx, Month 2018, pp 1-11
DOI: 10.1002/jbmr.3641
Diabetes Mellitus and the Benefit of Antiresorptive Therapy on Fracture Risk Richard Eastell, Eric Vittinghoff, Li-Yung Lui, Susan K. Ewing, Ann V. Schwartz,
Douglas C. Bauer, Dennis M. Black, and Mary L. Bouxsein Journal of Bone and Mineral Research, Vol. 37, No. 11, November 2022, pp 2121-2131.
DOI: 10.1002/jbmr.4697
1323 Lilly Detection of uninformative clinics during the trial of a new drug using statistical and machine learning techniques Praveen Deorani KKT Technology pte. Ltd. Craig, Kevin & Liman, Christian & Yan, Yang & Goyal, Shubham & Roy, Nawal. (2017). More of what works: Detection of informative sites during the conduct of clinical trials using machine learning.
10.13140/RG.2.2.11323.62242.

1331 Boehringer Ingelheim Impact of baseline diabetes and obesity statuses on outcomes post-ischemic stroke Colleen Bauza Medical University of South Carolina in Public Health Sciences Bauza, Colleen; Martin, Renee; Yeatts, Sharon D.; Borg, K; Magwood, Gayenell; Selassie, Anbesaw; and Ford, Marvella E. (2018) Determining the joint effect of obesity and diabetes on all-cause mortality and cardiovascular-related mortality following an ischemic stroke.
10.1155/2018/4812712

Bauza, Colleen; Martin, Renee; Yeatts, Sharon D.; Borg, K; Magwood, Gayenell; Selassie, Anbesaw; and Ford, Marvella E. (2018) Determining the joint effect of obesity and diabetes on functional disability at 3-months and on all-cause mortality at 1-year following an ischemic stroke.
10.1186/s12902-018-0255-1

1341 Boehringer Ingelheim, GSK, Novartis Vol-PACT: Improving Volumetric CT Metrics for Precision Analysis of Clinical Trial Results Geoffrey R. Oxnard Dana-Farber Cancer InstituteHarvard Medical School Vol-PACT: A Foundation for the NIH Public-Private Partnership That Supports Sharing of Clinical Trial Data for the Development of Improved Imaging Biomarkers in Oncology Laurent Dercle, Dana E. Connors, Ying Tang, Stacey J. Adam, et al
DOI: 10.1200/CCI.17.00137 JCO Clinical Cancer Informatics - March 2, 2018
1343 GSK Improving the Assessment of Systemic Lupus Erythematosus Disease Activity Zahi Touma University of Toronto, University Health Network Touma, Z., Gladman, D.D., Zandy, M., Su, J., Anderson, N. and Urowitz, M.B. (2020), Identifying a response for the systemic lupus erythematosus disease activity glucocorticoid index (SLEDAI‐2KG). Arthritis Care Res. Accepted Author Manuscript. doi:10.1002/acr.24261
1374 GSK A novel representation of vaccine efficacy trial datasets for use in computer simulation of vaccination policy Michael M. Wagner University of Pittsburgh Tajgardoon M, Wagner MM, VisweswaraS, Zimmerman RK. A Novel Representation of Vaccine Efficacy Trial Datasets for use in Computer Simulation of Vaccination Policy. AMIA Summits on Translational Science Proceedings. 2018;2017:389.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5961808/

1393 Roche Prognostic influence of body mass index and body weight gain in colorectal cancer patients treated with adjuvant chemotherapy: data from The AVANT study Sae-Won Han Department of Internal Medicine, Seoul National University Hospital Lee, DW., Cho, S., Shin, A. et al. Body mass index and body weight change during adjuvant chemotherapy in colon cancer patients: results from the AVANT trial. Sci Rep 10, 19467 (2020). https://doi.org/10.1038/s41598-020-76643-9
1401 Sanofi Use of Heparins in patients with Cancer: Individual patient-data meta-analysis of randomized trials Holger Schunemann McMaster University Schünemann HJ, Ventresca M, Crowther M, Briel M, Zhou Q, Noble S, Macbeth F, Griffiths G, Garcia D, Lyman GH, Di Nisio M, Iorio A, Mbuagbaw L, Neumann I, van Es N, Brouwers M, Guyatt G, Streiff MB, Marcucci M, Baldeh T, Florez ID, Alma OG, Solh Z, Bossuyt PM, Kahale LA, Ageno W, Bozas G, Büller HR, Lebeau B, Lecumberri R, Loprinzi C, McBane R, Sideras K, Maraveyas A, Pelzer U, Perry J, Klerk C, Agnelli G, Akl EA. Evaluating prophylactic heparin in ambulatory patients with solid tumours: a systematic review and individual participant data meta-analysis. Lancet Haematol. 2020 Oct;7(10):e746-e755.
https://doi.org/10.1016/S2352-3026(20)30293-3
van Es N, Ventresca M, Di Nisio M, Zhou Q, Noble S, Crowther M, Briel M, Garcia D, Lyman GH, Macbeth F, Griffiths G, Iorio A, Mbuagbaw L, Neumann I, Brozek J, Guyatt G, Streiff MB, Baldeh T, Florez ID, Gurunlu Alma O, Agnelli G, Ageno W, Marcucci M, Bozas G, Zulian G, Maraveyas A, Lebeau B, Lecumberri R, Sideras K, Loprinzi C, McBane R, Pelzer U, Riess H, Solh Z, Perry J, Kahale LA, Bossuyt PM, Klerk C, Büller HR, Akl EA, Schünemann HJ; IPDMA Heparin Use in Cancer Patients Research Group. The Khorana score for prediction of venous thromboembolism in cancer patients: An individual patient data meta-analysis. J Thromb Haemost. 2020 Aug;18(8):1940-1951.
https://doi.org/10.1111/jth.14824
1403 ViiV Mathematical modeling of the HIV transmission risk during the first 24 weeks after initiation of antiretroviral therapy in naïve HIV-infected MSM Juan Berenguer Hospital General Universitario Gregorio Marañón Abstract can be found here, presented at 9th IAS Conference on HIV Science, July 2017, Paris, France:

http://www.ias2017.org/LinkClick.aspx?fileticket=m3LSDs1z4QY%3d&;tabid=577&portalid=1

see page 502, abstract # WEPEC0967:
"HIV transmission from condomless anal intercourse differs by initial ART regimen in HIV-infected MSM"
1430 GSK Comparison of various remission criteria for SLE. A study based on the BLISS-52 and BLISS-76 clinical trials. Ronald van Vollenhoven Department of Medicine, Solna Parodis I#, Emamikia S#, Gomez A, Gentline C, Arkema EV, Chatzidionysiou K, van Vollenhoven RF. Evaluation of Definitions Of Remission In Systemic Lupus Erythematosus (DORIS): a post-hoc analysis of two randomised clinical trials. The Lancet Rheumatology. 2019 Sep; [Accepted; In production] #Contributed equally
https://www.thelancet.com/journals/lanrhe/article/PIIS2665-9913(19)30049-9/fulltext
1455 Boehringer Ingelheim Prediction of major bleeding in atrial fibrillation patients with a history of stroke or transient ischemic attack Jacoba Greving Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, the Netherlands http://stroke.ahajournals.org/content/early/2017/09/20/STROKEAHA.117.019183/tab-article-info
1456 ViiV Impact of ongoing side effects on the efficacy of initial antiretroviral therapy Andrew Carr St Vincent's Hospital, Sydney http://www.croiconference.org/sessions/fda-snapshot-algorithm-may-overestimate-efficacy-initial-art
1457 Lilly Initial severity and efficacy of antipsychotics for schizophrenia and bipolar mania: Individual participant level analyses of placebo-controlled studies. Stefan Leucht Department of Psychiatry and Psychotherapy TU-München https://www.ncbi.nlm.nih.gov/pubmed/28939419
1470 Takeda, UCB The efficacy of biologic drugs in short-duration versus long-duration inflammatory bowel disease Shomron Ben-Horin M.D. Gastroenterology Department, First Affiliated Hospital of Sun-YatSen University, Guangzhou, China Ben-Horin S, Zhao Y, Guo J, Mao R, Novack L, Sergienko R, Zhang J, Kobayashi T, Hibi T, Chowers Y, Colombel JF, Peyrin-Biroulet L, Kaplan G, Chen MH. Efficacy of biological drugs in short-duration versus long-duration inflammatory bowel disease: a protocol for a systematic review and an individual-patient level meta-analysis of randomised controlled trials. BMJ Open. 2019 Jan 25;9(1):e024222
1473 Roche Comparison of the pharmacokinetics of oral once-monthly 150mg ibandronate between ethnic Europeans and Taiwan post-menopausal osteoporotic women across two phase 1 studies Keh-Sung Tsai (1) Department of Laboratory Medicine, National Taiwan University Hospital(2) Institute of Epidemiology and Preventive Medicine, National Taiwan University https://link.springer.com/article/10.1007%2Fs00198-019-05127-y
1475 Boehringer Ingelheim Predicting safety and efficacy of afatinib treatment of NSCLC Assoc/Prof Michael Sorich Flinders Centre for Innovation in Cancer, Flinders University, Adelaide, Australia Cancers 2018, 10, 384; doi:10.3390/cancers10100384
https://www.mdpi.com/2072-6694/10/10/384
1528 GSK A Swapping Method for Average Treatment Effect Estimation Bimal Sinha Statistics, the University of Maryland at Baltimore County (UMBC) https://www.tci-thaijo.org/index.php/thaistat/article/view/163194/117937
1558 GSK, Novartis Development of historical control using placebo data from pediatric epilepsy studies Anthony Daniels UCB BioSciences, Inc 8010 Arco Corporate DriveSuite 175Raleigh NC 27613 Results summary available on the CSDR website.
1569 GSK Melancholic symptoms in bipolar depression and response to lamotrigine Dr. Evyn Peters Department of Psychiatry, University of Saskatchewan (U of S), Saskatchewan, Canada Peters, E. M., Bowen, R., & Balbuena, L. (2018). Melancholic Symptoms in Bipolar II Depression and Responsiveness to Lamotrigine in an Exploratory Pilot Study. Journal of clinical psychopharmacology.
DOI: 10.1097/JCP.0000000000000947

https://journals.lww.com/psychopharmacology/Fulltext/2018/10000/Melancholic_Symptoms_in_Bipolar_II_Depression_and.18.aspx


1572 Boehringer Ingelheim, Eisai, GSK, Lilly Research to evaluate the relation of toxicity and the relative dose intensity in phase I trials beyond cycle 1 of Molecular Targeted Agents (MTAs) Kan Yonemori, MD., PhD Department of Breast and Medical OncologyNational Cancer Center Hospital, National Cancer Center, Japan Hirakawa, A., Sudo, K., Yonemori, K., Sadachi, R., Kinoshita, F., Kobayashi, Y., Okuma, H.S., Kawachi, A., Tamura, K., Fujiwara, Y., Rubinstein, L. and Takebe, N. (2019), A Comparative Study of Longitudinal Toxicities of Cytotoxic Drugs, Molecularly Targeted Agents, Immunomodulatory Drugs, and Cancer Vaccines. Clin. Pharmacol. Ther., 106: 803-809.
https://doi.org/10.1002/cpt.1442
Drug induced interstitial lung disease in oncology phase I trials
Kan Yonemori Akihiro Hirakawa Asuka Kawachi Fumie Kinoshita Hitomi Okuma Tadaaki Nishikawa Kenji Tamura Yasuhiro Fujiwara Naoko Takebe
Cancer Sci 107 (2016) 1830- 1836
https://doi.org/10.1111/cas.13087
Hirakawa, A, Yonemori, K, Kinoshita, F, et al. Potential utility of a longitudinal relative dose intensity of molecularly targeted agents in phase 1 dose‐finding trials. Cancer Sci. 2018; 109: 207- 214
https://doi.org/10.1111/cas.13436

1575 GSK, Lilly Early improvement in individual symptoms and response to antidepressants in patients with major depressive disorder Ymkje Anna de Vries Interdisciplinary Center Psychopathology and Emotion regulation, University Center of Psychiatry, University Medical Center Groningen, the Netherlands https://doi.org/10.1192/bjp.2018.122
1581 GSK MASTERMIND: Assessing the cost effectiveness of a stratified approach to type 2 diabetes therapy Professor Chris Jennison University of Bath Dennis JM, Henley WE, Weedon MN, Lonergan M, Rodgers LR, Jones AG, Hamilton WT, Sattar N, Janmohamed S, Holman RR, Pearson ER, Shields BM, Hattersley AT; MASTERMIND Consortium. Sex and BMI Alter the Benefits and Risks of Sulfonylureas and Thiazolidinediones in Type 2 Diabetes: A Framework for Evaluating Stratification Using Routine Clinical and Individual Trial Data. Diabetes Care. 2018 Sep;41(9):1844-1853.
DOI: 10.2337/dc18-0344
1593 GSK JANUVIA/JANUMET HTA Submission(Germany) Dr. Rainer Woker MSD Sharp & Dohme GmbH https://www.g-ba.de/informationen/nutzenbewertung/398/
1595 Boehringer Ingelheim, GSK, Lilly, Roche A Novel Approach to Developing Comprehensive Profile of Adverse Event (AE) Data from Clinical Trials Sharayu Paranjpe Cytel Statistical Software and Services Pvt. Ltd Sharayu Paranjpe & Anil Gore. Adversity Index for Clinical Trials: An Inclusive Approach for Analysis of Safety Data.

https://arxiv.org/abs/1806.00204
1599 Roche Predictors of exposure, adverse and therapeutic effects of BRAF/MEK inhibitors in advanced melanoma. Michael Sorich Flinders University https://www.ncbi.nlm.nih.gov/pubmed/30758912
1601 Sanofi Identification of clinical biomarkers for adjuvant chemotherapy for gastric cancer after D2 dissection by analyses of individual patents’ data from large randomized controlled trials Akira Tsuburaya, MD PhD Chief of Surgery, JCHO Nihonmatsu HospitalResearch Professor, Fukushima Medical University Tsuburaya A, Guan J, Yoshida K, Kobayashi M, Yoshino S, Tanabe K, Yoshikawa T, Oshima T, Miyashita Y, Sakamoto J, Tanaka S. Clinical biomarkers in adjuvant chemotherapy for gastric cancer after D2 dissection by a pooled analysis of individual patient data from large randomized controlled trials. Gastric Cancer. 2021 Aug 7
doi: 10.1007/s10120-021-01228-y
1622 ViiV A systematic literature review and Individual patient-level data enhanced network meta-analysis to determine the comparative efficacy and safety of first-line HIV antiretroviral therapies Steve Kanters School of Population and Public Health Kanters, S. (2019). Comparative efficacy and safety of first-line treatments for HIV patients for clinical guideline development and the impact of individual patient data. University of British Columbia.

https://open.library.ubc.ca/collections/ubctheses/24/items/1.0383244
doi 10.14288/1.0383244
1624 Lilly A Meta-analysis of Tardive Dyskinesia Rates in Studies Comparing Second Generation Antipsychotics (SGAs) with each other or to First-Generation Antipsychotics (FGAs). Christoph U Correll The Zucker Hillside Hospital Carbon M, Kane JM, Leucht S, Correll CU. Tardive dyskinesia risk with first-and second-generation antipsychotics in comparative randomized controlled trials:
a meta-analysis. World Psychiatry. 2018 Oct;17(3):330-340. doi:
10.1002/wps.20579. PubMed PMID: 30192088; PubMed Central PMCID: PMC6127753.
1626 GSK Factors associated with Prostate Cancer in Prostate Needle Biopsy Daniel M. Moreira University of Illinois at Chicago https://doi.org/10.1016/j.juro.2018.06.018
1629 GSK Assessing sex-differences and the effect of timing of vaccination on immunogenicity, reactogenicity and efficacy of vaccines in young children Merryn Voysey University of Oxford https://doi.org/10.1016/j.vaccine.2017.09.002
1630 GSK A framework for individualized prediction of the rate and severity of asthma exacerbations Mohsen Sadatsafavi Faculty of Pharmaceutical Sciences and Faculty of Medicine, University of British Columbia https://www.atsjournals.org/doi/abs/10.1164/ajrccm-conference.2018.197.1_MeetingAbstracts.A7412
1633 ViiV Comparative effect of dolutegravir and raltegravir on CD4+/CD8+ ratio, CD4%, and multiple T-cell marker recovery. SPRING-2 study. Jose Ramon Blanco Hospital San Pedro - Center for Biomedical Research of La Rioja (CIBIR), SPAIN Blanco JR, Alejos B, Moreno S. Immune recovery markers in a double blind clinical trial comparing dolutegravir and raltegravir based regimens as initial therapy (SPRING-2). PLoS One. 2020 Jan 16;15(1):e0226724.
https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0226724
1640 GSK Effect of Fluticasone/Salmeterol on Chronic Bronchitis Symptoms and Associated Patient Reported Outcomes: a post-hoc analysis of the TORCH trial Victor Kim Lewis Katz School of Medicine, Temple University. https://www.atsjournals.org/doi/abs/10.1164/ajrccm-conference.2018.197.1_MeetingAbstracts.A7727
1660 Sanofi Assessing the generalizability of all-cause mortality from the MOSAIC trial to older adults diagnosed with stage II and III colon cancer in SEER-Medicare Jennifer L. Lund University of North Carolina at Chapel Hill, Department of Epidemiology, Gillings School of Global Public Health Lund JL, Webster-Clark MA, Hinton SP, Shmuel S, Stürmer T, Sanoff HK. Effectiveness of adjuvant FOLFOX vs 5FU/LV in adults over age 65 with stage II and III colon cancer using a novel hybrid approach. Pharmacoepidemiol Drug Saf. 2020 Oct 4.
https://doi.org/10.1002/pds.5148
1691 GSK Longitudinal Concurrent and Predictive Biomarkers of Clinical Disease Severity in Systemic Lupus Erythematosus in BLISS-52/BLISS-76 Austin Huang Pfizer Research Proposal 1691 Summary of Results
Pre-competitive Analysis of Markers of Systemic Lupus Erythematosus (SLE) to aid design of Phase II studies using patient level Phase III Clinical Study Data
Satyaprakash Nayak, Austin Huang, Mark Peterson, Maria Dilleen
Affiliation: Pfizer Inc.,
Objectives: Systemic Lupus Erythematosus (SLE) is a complex, auto-immune disease with an unmet medical need and only one approved therapy (Belimumab) in the past half-century. The objective of this analysis was to analyze Phase III patient level data to enhance our understanding of biomarker response and its predictive relationship to treatment efficacy in an effort to provide ways of gaining inference and leading to design of smaller, shorter and more efficient Phase 2 studies. The main objective was to characterize the relationship between biomarkers from the BLISS Phase 3 studies and co-occurring and subsequent changes in SLE clinical disease severity. The second objective was to identify prognostic markers of disease severity within patient disease trajectories. While other studies have examined these data for baseline predictors of response, this analysis examines markers at multiple intermediate time points as potential predictors of disease progression.
Methods: Patient-level data from two Belimumab Phase III studies (BLISS-52 and BLISS-76) were requested through the GSK SAS Clinical Study Data Request portal which allows a precompetitive data access for analysis. There were 1,122 patients starting on Belimumab and 562 patients starting on Placebo for up to 76 weeks. We examined relationships using univariate marginal correlations as well as multivariate analyses using R software, which modelled biomarker predictors of clinical response in a longitudinal model. Clinical response was assessed using the SLE Response Index [SRI(4)]. The univariate and multivariate relationships between lab (biomarker) and clinical endpoints on clinical response, were quantified and graphically depicted for comparisons. Biomarkers examined included anti-double stranded DNA (Anti-dsDNA), antinuclear antibody (ANA), primary compliments C3 and C4, lymphocytes, and CPX (cardiopulmonary stress test). Clinical predictors were examined using the systematic lupus erythematosus disease activity index SLEDAI-2K.
Results: Consistent with prior findings and our initial hypotheses, SLE response to treatment as measured by SLE Response Index [SRI(4)] (both active and placebo) was seen to be correlated most strongly with baseline disease severity as measured by baseline SLEDAI-2K. The population distribution of disease severity equilibrates between 160-200 days. Multivariate clustering using individual discrete time assessments over a timespan up to 200 days of SLE disease activity index (SLEDAI-2K), indicated that the future disease status is highly dependent on current disease status. With respect to biomarkers - anti-dsDNA and complement levels (C3 and C4) were found to be highly correlated with the disease activity SLEDAI-2K, however even for these biomarkers, the SLEDAI-2K changes were found to be most highly correlated with baseline levels of these markers, and thus under-score the limitations of the activity index to study disease progression and treatment efficacy.
Conclusions: We present a mechanism to access and analyze rich, subject-level data for understanding SLE and designing clinical studies. Our analysis demonstrates an explanatory hypothesis that the common inclusion criteria in the clinical trials tend to enrich for transiently-flaring subjects, and thus a need for longer than 6 months study as the disease equilibrates at around 200 days. However, it should also be noted that patients in a clinical trial receive better care and monitoring when they enroll in a study. Caution should be applied in extrapolating short term trial outcomes to long term disease activity. We also observed a positive correlation between baseline SLEDAI-2K and placebo response rate as measured by SRI.
1692 Boehringer Ingelheim, GSK Predictors of chronic obstructive pulmonary disease progression Akihiro Hisaka Laboratory of Clinical Pharmacology and Pharmacometrics, Graduate School of Pharmaceutical Sciences, Chiba university, Chiba, Japan Kawamatsu, S.; Jin, R.; Araki, S.; Yoshioka, H.; Sato, H.; Sato, Y.; Hisaka, A. Scores of Health-Related Quality of Life Questionnaire Worsen Consistently in Patients of COPD: Estimating Disease Progression over 30 Years by SReFT with Individual Data Collected in SUMMIT Trial. J. Clin. Med. 2020, 9, 2676

https://doi.org/10.3390/jcm9082676
1693 Lilly, Novartis Identifying Subgroups of Response to Biologics in Psoriasis using Large-scale Patient-level Data Nophar Geifman University of Manchester Nophar Geifman, Narges Azadbakht, Jiaping Zeng, Toby Wilkinson, Nick Dand, Iain Buchan, Deborah Stocken, Richard B. Warren, Jonathan Barker, Nick J. Reynolds, Michael R. Barnes, Catherine H. Smith, Christopher E. M. Griffiths, Niels Peek, and the BADBIR Study Group, on behalf of the PSORT Consortium. British Journal of Dermatology, Volume 185, Issue 4, 1 October 2021, Pages 825-835. Defining Treatment Response Trajectoriesin Psoriasis using Large-scale Patient-level Data.
DOI: 10.1111/bjd.20140
1695 GSK Outcome measures and baseline predictors of response to belimumab treatment. Ioannis Parodis Department of Medicine, Rheumatology Unit, Karolinska Institutet, Karolinska University Hospital, Stockholm, Sweden Ioannis Parodis, Sharzad Emamikia, Alvaro Gomez, Iva Gunnarsson, Ronald F. van Vollenhoven & Katerina Chatzidionysiou
(2018): Clinical SLEDAI-2K zero may be a pragmatic outcome measure in SLE studies, Expert Opinion on Biological Therapy,

https://www.tandfonline.com/doi/full/10.1080/14712598.2019.1561856

http://dx.doi.org/10.1136/annrheumdis-2018-214880

https://academic.oup.com/rheumatology/advance-article/doi/10.1093/rheumatology/kez191/5510116?guestAccessKey=3ad38e37-5e79-460f-af2b-37672a291dee

Antimalarial agents diminish while methotrexate, azathioprine and mycophenolic acid increase BAFF levels in systemic lupus erythematosus. Hernández-Breijo B, Gomez A, Soukka S, Johansson P, Parodis I.
Autoimmun Rev. 2019 Aug 10:102372. doi:
10.1016/j.autrev.2019.102372

https://doi.org/10.1016/j.autrev.2019.102372


https://doi.org/10.1093/rheumatology/keaa453
https://doi.org/10.3390/jcm9061813

1702 Roche Pooled analysis of cardiac safety of T-DM1 in HER2-positive metastatic breast cancer patients Evandro de Azambuja Institut Jules BordetBrEAST Data Center, Brussels Belgium Arlindo R. Ferreira, Sofia Ferreira, Matteo Lambertini, Christian Maurer, Samuel Martel, Luis Costa, Noam Ponde, Evandro de Azambuja,
Association between pertuzumab-associated diarrhoea and rash and survival outcomes in patients with HER2-positive metastatic breast cancer: Exploratory analysis from the CLEOPATRA trial, European Journal of Cancer, Volume 144, 2021, Pages 351-359, ISSN 0959-8049,
https://doi.org/10.1016/j.ejca.2020.11.023.
1731 GSK Host characteristics impacting Rotarix immunogenicity and correlates of protection for rotavirus gastroenteritis, a multi-site pooled analysis of individual-level clinical trial data Julia M. Baker Department of Epidemiology, Rollins School of Public Health, Emory University http://ars.samrc.ac.za/ARS%202019/ARS%20posters/Baker%20Oral%20polio%20vaccine%20interferes%20.pdf

http://ars.samrc.ac.za/ARS%202019/ARS%20posters/Baker%20Assessing%20serum%20anti.pdf
1732 Astellas, Boehringer Ingelheim, GSK, Lilly, Novartis, Roche, Sanofi, Takeda, UCB Assessing heterogeneity in relative treatment efficacy by age, sex and comorbidity. Dr David A McAllister University of Glasgow https://bmcmedicine.biomedcentral.com/articles/10.1186/s12916-019-1427-1#article-info

Hanlon, P., Hannigan, L., Rodriguez-Perez, J. et al. Representation of people with comorbidity and multimorbidity in clinical trials of novel drug therapies: an individual-level participant data analysis. BMC Med 17, 201 (2019)

DOI: 10.1186/s12916-019-1427-1

https://bmcmedicine.biomedcentral.com/articles/10.1186/s12916-020-01752-1

Hanlon, P., Butterly, E., Lewsey, J. et al. Identifying frailty in trials: an analysis of individual participant data from trials of novel pharmacological interventions. BMC Med 18, 309 (2020).

https://doi.org/10.1186/s12916-020-01752-1

1741 Lilly, Novartis, Roche Predictors of exposure, therapeutic and adverse effects of drugs used in the treatment of advanced breast cancer and advanced colorectal cancer. Dr Ashley Mark Hopkins Flinders University https://www.frontiersin.org/articles/10.3389/fonc.2019.00789/full
Lim, H.H., Hopkins, A.M., Rowland, A. et al. Targ Oncol (2019) 14: 743. https://doi.org/10.1007/s11523-019-00683-z
1758 Novartis Change in Albuminuria and GFR as End Points for Clinical Trials in Early Stages of Chronic Kidney Disease Lesley A. Inker, MD Tufts Medical Center/Tufts Medical School Collier, W.; Inker, L.A.; Haaland, B.; Appel, G.B.; Badve, S.V.; Caravaca-Fontán, F.; Chalmers, J.; Floege, J.; Goicoechea, M.; Imai, E.; Jafar, T.H.; Lewis, J.B.; Li, P.K.T.; Locatelli, F.; Maes, B.D.; Neuen, B.L.; Perrone, R.D.; Remuzzi, G.; Schena, F.P.; Wanner, C.; Heerspink, H.J.L.; Greene, T.; The Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI). CJASN 18(2):p 183-192, February 2023. Evaluation of Variation in the Performance of GFR Slope as a Surrogate End Point for Kidney Failure in Clinical Trials that Differ by Severity of CKD.
DOI: 10.2215/CJN.0000000000000050

Inker, L.A., Collier, W., Greene, T. et al. A meta-analysis of GFR slope as a surrogate endpoint for kidney failure. Nat Med 29, 1867-1876 (2023).
DOI: https://doi.org/10.1038/s41591-023-02418-0
1779 GSK Evaluation of the effect of inhaled corticosteroids (ICS) on blood eosinophil count (EOS) in patients with COPD Professor Jørgen Vestbo DMSc FRCP FERS Division of Infection, Immunity and Respiratory MedicineUniversity of Manchester, UK https://erj.ersjournals.com/content/52/suppl_62/OA2125
1819 GSK INDIVIDUAL PARTICIPANT DATA META-ANALYSIS OF ANTIDEPRESSANT TRIALS FOR MAJOR DEPRESSION IN JAPAN Shigeto Yamawaki Hiroshima University Norio Watanabe, Kazushi Maruo, Hissei Imai, Kazutaka Ikeda, Shigeto Yamawaki, Toshi A. Furukawa. Predicting antidepressant response through early improvement of individual symptoms of depression incorporating baseline characteristics of patients: An individual patient data meta-analysis, Journal of Psychiatric Research, Volume 125, 2020, Pages 85-90
https://doi.org/10.1016/j.jpsychires.2020.03.009

Furukawa, TA, Maruo, K, Noma, H, Tanaka, S, Imai, H, Shinohara, K, Ikeda, K, Yamawaki, S, Levine, SZ, Goldberg, Y, Leucht, S, Cipriani, A. Initial severity of major depression and efficacy of new generation antidepressants: individual‐participant data meta‐analysis
https://doi.org/10.1111/acps.12886

Hisashi Noma, Toshi A. Furukawa, Kazushi Maruo, Hissei Imai, Kiyomi Shinohara, Shiro Tanaka, Kazutaka Ikeda, Shigeto Yamawaki, Andrea Cipriani. Exploratory analyses of effect modifiers in the antidepressant treatment of major depression: Individual-participant data meta-analysis of 2803 participants in seven placebo-controlled randomized trials,
Journal of Affective Disorders, Volume 250, 2019, Pages 419-424.
https://doi.org/10.1016/j.jad.2019.03.031

Noma, H., Maruo, K., Gosho, M. et al. Efficient two-step multivariate random effects meta-analysis of individual participant data for longitudinal clinical trials using mixed effects models. BMC Med Res Methodol 19, 33 (2019).
https://doi.org/10.1186/s12874-019-0676-1

Shinohara K, Tanaka S, Imai H, et alDevelopment and validation of a prediction model for the probability of responding to placebo in antidepressant trials: a pooled analysis of individual patient dataEvidence-Based Mental Health 2019;22:10-16.
https://doi.org/10.1136/ebmental-2018-300073

1843 GSK The genetics of glycaemic response to GLP-1 receptor agonists in Type 2 diabetes Ewan Pearson University of DundeeDundee DD1 9SY Pharmacogenomics of GLP-1 receptor agonists: a genome-wide analysis of observational data and large randomised controlled trials Adem Y Dawed, Andrea Mari, Andrew Brown, Timothy J McDonald, Lin Li, Shuaicheng Wang, et al. The Lancet Diabetes and Endocrinology January, 2023
DOI:https://doi.org/10.1016/S2213-8587(22)00340-0
1844 GSK Real World Effects of Medications for Chronic Obstructive Pulmonary Disease Dr Kevin Wing London School of Hygiene & Tropical medicine (LSHTM) Real World Effects of Medications for COPD - a UK Population-Based Non-Interventional Cohort Study With Validation Against Randomised Trial Results
Kevin Wing, Elizabeth Williamson, James Carpenter, Lesley Wise, Sebastian Schneeweiss, Liam Smeeth, Jennifer Quint, Ian Douglas
European Respiratory Journal Sep 2019, 54 (suppl 63) PA2508; DOI: 10.1183/13993003.congress-2019.PA2508
1847 Sanofi Antiangiogenic Second line Lung cancer Meta-Analysis (ANSELMA) - A meta-analysis on antiangiogenic agents in advanced non-small cell lung cancer patients who failed first-line chemotherapy. Benjamin Besse University Paris-Sud and Gustave Roussy, Department of Medicine 114 Rue Edouard Vaillant, 94805 Villejuif Cedex, FrancePhone: +33 (0)1 42 11 43 22 Fax: +33 (0)1 42 11 52 19 Remon J, Lacas B, Herbst R, Reck M, Garon EB, Scagliotti GV, Ramlau R, Hanna N, Vansteenkiste J, Yoh K, Groen HJM, Heymach JV, Mandrekar SJ, Okamoto I, Neal JW, Heist RS, Planchard D, Pignon JP, Besse B; ANSELMA collaborative group.
ANtiangiogenic Second-line Lung cancer Meta-Analysis on individual patient data in non-small cell lung cancer: ANSELMA. Eur J Cancer. 2022 Mar 11;166:112-125.
https://doi.org/10.1016/j.ejca.2022.02.002
PMID: 35286903
1857 GSK, Novartis Comparative safety and effectiveness of cognitive enhancers for Alzheimer's dementia: a systematic review and individual patient data network meta-analysis Andrea C. Tricco Knowledge Translation Program, Li Ka Shing Knowledge Institute, St. Michael's Hospital A.A. Veroniki, H.M.Ashoor, P.Rios, G.Seitidis, L.Stewart, M.Clarke, C.Tudur-Smith, D.Mavridis, B.R.Hemmelgarn, J.Holroyd-Leduc, S.E.Straus, A.C.Tricco. BMJ Open Volume 12, Issue 4. Comparative safety and efficacy of cognitive enhancers for Alzheimer's dementia: a systematic review with individual patient data network meta-analysis.
DOI: 10.1136/bmjopen-2021-053012
1907 GSK Critical characterization of the impact of clinical-pathological tumoral features on recurrence risk dynamics of NSCLS. Tommaso De Pas European institute of Oncology , Milan https://doi.org/10.1016/j.ejca.2019.11.005
1925 GSK EstablishINg the best STEp-up treatments for children with uncontrolled asthma despite Inhaled corticosteroids (EINSTEIN): A systematic review, network meta-analysis and cost effectiveness analysis Catrin Tudur Smith University of Liverpool Best step-up treatments for children with uncontrolled asthma: a systematic review and network meta-analysis of individual participant data Sofia Cividini, Ian Sinha, Sarah Donegan, Michelle Maden, Katie Rose, Olivia Fulton, Giovanna Culeddu, Dyfrig A. Hughes, Stephen Turner, Catrin Tudur Smith on behalf of the EINSTEIN Collaborative Group European Respiratory Journal 2023 62: 2301011
DOI: 10.1183/13993003.01011-2023
1933 Novartis Benefit-harm assessment of Fingolimod: a novel methodology to inform patients with MS, industry, guideline developers and regulatory agencies on the balance of benefits and harms Alessandra Spanu University of ZurichInstitute of Social and Preventive MedicineHirschengraben 84CH-8001 Zurich Spanu A, Aschmann HE, Kesselring J, Puhan MA. Fingolimod versus interferon beta 1-a: Benefit-harm assessment approach based on TRANSFORMS individual patient data. Multiple Sclerosis Journal - Experimental, Translational and Clinical. 2022;8(3). doi:10.1177/20552173221117784

Spanu A, Aschmann HE, Kesselring J, Puhan MA Benefit-harm balance of fingolimod in patients with MS: A modelling study based on FREEDOMS Multiple Sclerosis and Related Disorders VOLUME 46, Nov 2020.
https://doi.org/10.1016/j.msard.2020.102464
1934 GSK Using zanamivir trial data to evaluate baseline characteristics and disease progression by various subgroups to inform clinical development of novel therapies in hospitalized patients with influenza Lesley Butler Genentech, Inc., A member of the Roche Group https://clinicalstudydatarequest.com/Documents/All%20Results_19March2018.xlsx
2074 Roche Association between pertuzumab induced diarrhea and cutaneous rash and survival outcomes in patients with HER2-positive metastatic breast cancer enrolled in the CLEOPATRA trial Evandro de Azambuja Institut Jules Bordet Arlindo R. Ferreira, Sofia Ferreira, Matteo Lambertini, Christian Maurer, Samuel Martel, Luis Costa, Noam Ponde, Evandro de Azambuja,
Association between pertuzumab-associated diarrhoea and rash and survival outcomes in patients with HER2-positive metastatic breast cancer: Exploratory analysis from the CLEOPATRA trial, European Journal of Cancer, Volume 144, 2021, Pages 351-359, ISSN 0959-8049,
https://doi.org/10.1016/j.ejca.2020.11.023.
2084 GSK Relationship between plasma levels of a1-Antitrypsin levels and the severity of airflow limitation Marc Miravitlles Pneumology Department. Hospital Universitari Vall d'Hebron. Barcelona, Spain https://www.archbronconeumol.org/en-serum-levels-alpha1-antitrypsin-their-relationship-articulo-S1579212920300100

DOI: 10.1016/j.arbres.2019.03.001

5453 Roche Evaluation of Postmastectomy Radiotherapy in Women with HER-2 positive Breast Cancer Youssef Zeidan American University of Beirut, Medical Center Abi Jaoude J, de Azambuja E, Makki M, et al. Post-Mastectomy Radiation Therapy in Human Epidermal Growth Factor Receptor 2 Positive Breast Cancer Patients: Analysis of the HERA Trial. Int J Radiat Oncol Biol Phys. 2020;106(3):503-510. doi:10.1016/j.ijrobp.2019.10.022
5459 GSK Placebo Effects in Asthma Randomized Clinical Trials: Their Magnitudes, Causes and Potential for Improving Care Shawn D. Aaron The Ottawa Hospital Research Institute, University of Ottawa https://www.atsjournals.org/doi/full/10.1513/AnnalsATS.201901-071OC
5460 GSK The evaluation of hemagglutination-inhibition antibody titer as a mediator of vaccine-induced protection against laboratory-confirmed influenza infections Prof Benjamin J Cowling School of Public Health, Li Ka Shing Faculty of Medicine, The University of Hong Kong. Wey Wen Lim, Shuo Feng, Sook-San Wong, Sheena G Sullivan, Benjamin J Cowling, Hemagglutination Inhibition Antibody Titers as Mediators of Influenza Vaccine Efficacy Against Symptomatic Influenza A(H1N1), A(H3N2), and B/Victoria Virus Infections, The Journal of Infectious Diseases, 2024
DOI: https://doi.org/10.1093/infdis/jiae122
5494 Sanofi Improving Colon Cancer Therapy Decisions by Extending Trial Representation Jennifer Lund Department of Epidemiology, University of North Carolina at Chapel Hill Effectiveness of adjuvant FOLFOX versus 5FU for colon cancer treatment in community oncology practice using a hybrid study approach.
Jennifer Leigh Lund, Michael Webster-Clark, Alexander P Keil, Daniel Westreich, Til Sturmer, and Hanna Kelly Sanoff
Journal of Clinical Oncology 2020 38:15_suppl, 7067-7067
https://ascopubs.org/doi/abs/10.1200/JCO.2020.38.15_suppl.7067

Longitudinal cumulative dose: A novel measure to assess multiple dimensions of chemotherapy adherence over time.
Michael Webster-Clark, Alexander P Keil, Hanna Kelly Sanoff, Til Sturmer, Daniel Westreich, and Jennifer Leigh Lund
Journal of Clinical Oncology 2020 38:15_suppl, 3522-3522
https://ascopubs.org/doi/abs/10.1200/JCO.2020.38.15_suppl.3522

Jennifer L. Lund, Michael A. Webster-Clark, Til Sturmer, Daniel Westreich, Hanna K. Sanoff and Alexander P. Keil. A picture is worth 1000 words: Visual tools to guide transport of trial results to real-world populations. Pharmacoepidemiology and Drug Safety. Oct 2020: 29(S3): 374.

https://doi.org/10.1002/pds.5114
Jennifer L. Lund, Michael A. Webster-Clark, Alexander P. Keil, Daniel Westreich, Til Sturmer and Hanna K Sanoff. Transporting treatment effects from clinical trials to clinical practice using a hybrid study approach: The case of adjuvant FOLFOX versus 5FU for colon cancer treatment. Pharmacoepidemiology and Drug Safety. Oct 2020: 29(S3): 115.

https://doi.org/10.1002/pds.5114

Michael A. Webster-Clark, Alexander Keil, Hanna K. Sanoff, Til Stürmer, Daniel Westreich, Jennifer L. Lund. Longitudinal cumulative dose: A novel measure to evaluate multiple dimensions of chemotherapy adherence over time. Pharmacoepidemiology and Drug Safety. Oct 2020: 29(S3): 198.

https://doi.org/10.1002/pds.5114

Webster-Clark M, Keil AP, Sanoff HK, Stürmer T, Westreich D, Lund JL. Introducing longitudinal cumulative dose to describe chemotherapy patterns over time: Case study of a colon cancer trial. Int J Cancer. 2021 Jul 15;149(2):394-402. doi: 10.1002/ijc.33565. Epub 2021 Mar 26. PMID: 33729546.

https://doi.org/10.1002/ijc.33565

5521 GSK Impact of HPV vaccination in preventing subsequent infection and disease after excision treatment Fanghui Zhao National Cancer Center & Cancer Hospital, Chinese Academy of Medical Sciences Zhao, S., Hu, S., Xu, X. et al. Impact of HPV-16/18 AS04-adjuvanted vaccine on preventing subsequent infection and disease after excision treatment: post-hoc analysis from a randomized controlled trial. BMC Infect Dis 20, 846 (2020).

https://doi.org/10.1186/s12879-020-05560-z
5525 GSK Novel approaches for the analysis of SLE clinical trials Mimi Kim Albert Einstein College of Medicine Kim M, Pradhan K, Izmirly P, Kalunian K, Hanrahan L, Merrill J. Identifying Subgroups of SLE Patients with Differential Responses to a BLyS Inhibitor: Application of a Machine Learning Algorithm to Clinical Trial Data [abstract]. Arthritis Rheumatol. 2019; 71 (suppl 10).
https://acrabstracts.org/abstract/identifying-subgroups-of-sle-patients-with-differential-responses-to-a-blys-inhibitor-application-of-a-machine-learning-algorithm-to-clinical-trial-data/
5642 GSK FEV1 decline across BMI gradient in COPD patients who were part of large randomized controlled trial over at least 3 years. Don D Sin Centre for Heart Lung Innovation, St Paul's Hospital and Division of Respiratory Medicine, University of British Columbia,Vancouver, BC V6Z 1Y6, Canada Sun, Y., Milne, S., Jaw, J.E. et al. BMI is associated with FEV1 decline in chronic obstructive pulmonary disease: a meta-analysis of clinical trials. Respir Res 20, 236 (2019).

https://doi.org/10.1186/s12931-019-1209-5
5658 GSK Does Shingrix vaccination reduces the risk of stroke? Benson Ogunjimi University of Antwerp & Antwerp University Hospital Primary objective was whether stroke occurrence is affected by Shingrix looking at several time windows after vaccination(0-1, 0-2, 0-3 and 0-4). Therefore, a logistic regression using heart attract/strokes during the first year after vaccination as a dependent variable was performed. We only looked at the first year since adverse effects were only collected the first year. Thus the other time windows could not be considered. The model was adjusted for confounding factors such as: hypertension, gender, age, diabetes and race. We did not find a significant effect of the vaccine on the dependent variable. Significant effect was seen with variables age, diabetic, hypertension and gender.
We conclude that occurrence of a stroke is not affected by Shingrix.
5742 Boehringer Ingelheim, GSK, Novartis Comparison of the effects of dual and single bronchodilators in COPD patients relocated from group D to group B by the revised 2017 GOLD classification: a post-hoc pooled analysis of global RCTs Yeon-Mok Oh Professor, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South KoreaHead, the Department of Pulmonary and Critical Care Medicine, Asan Medical Center, Seoul, South Korea Kang, J., Lee, J.S., Lee, S.W. et al. Dual versus monotherapy with bronchodilators in GOLD group B COPD patients according to baseline FEV1 level: a patient-level pooled analysis of phase-3 randomized clinical trials. Respir Res 22, 55 (2021)
https://doi.org/10.1186/s12931-021-01648-5
5769 GSK The risk of recurrent Plasmodium vivax malaria and haematological effect of treatment with or without primaquine: a systematic review and individual patient data meta-analysis Rob Commons Menzies School of Health Research, Darwin, Australia WorldWide Antimalarial Resistance Network (WWARN), University of Oxford, UK Effect of primaquine dose on the risk of recurrence in patients with uncomplicated Plasmodium vivax: a systematic review and individual patient data meta-analysis R.J.Commons, M.Rajasekhar, P.Edler,T.Abreha, G.R.Awab, J.K.Baird, B.E.Barber, C.S.Chu, L.Cui, A.Daher, L.Gonzalez-Ceron, M.J.Grigg, J.Hwang,Harin Karunajeewa, M.V.G.Lacerda, S.Ladeia-Andrade et al. The Lancet Infectious Diseases (2024)
DOI: https://doi.org/10.1016/S1473-3099(23)00430-9
Primaquine dose and the risk of haemolysis in patients with uncomplicated Plasmodium vivax malaria: a systematic review and individual patient data meta-analysis Megha Rajasekhar, Julie A Simpson, Benedikt Ley, Peta Edler, Cindy S Chu, Tesfay Abreha, Ghulam R Awab, J Kevin Baird, Germana Bancone, Bridget E Barber, Matthew J Grigg, Jimee Hwang, Harin Karunajeewa, Marcus V G Lacerda, Simone Ladeia-Andrade et al. The Lancet Infectious Diseases (2024)
DOI: https://doi.org/10.1016/S1473-3099(23)00431-0
5775 Roche Early identification of immunotherapy response based on computational models Jakob Nikolas Kather Applied Tumor Immunity (D120) National Center for Tumor Diseases (NCT) German Cancer Research Center (DKFZ) Im Neuenheimer Feld 460, D-69120 Heidelberg, Germany Gastroenterology and Gastrointestinal Oncology University Hospital RWTH Aachen Pauwelsstraße 30, D-52074 Aachen, Germany Classical Mathematical Models for Prediction of Response to Chemotherapy and Immunotherapy
Narmin Ghaffari Laleh, Chiara Maria Lavinia Loeffler, Julia Grajek, Kateřina Staňková, Alexander T. Pearson, Hannah Sophie Muti, Christian Trautwein, Heiko Enderling, Jan Poleszczuk, Jakob Nikolas Kather
bioRxiv 2021.10.23.465549; doi: https://doi.org/10.1101/2021.10.23.465549
5796 GSK Symptom level analysis of recovery during antidepressant treatment Markus Jokela Department of Psychology and Logopedics, Medical Faculty, University of Helsinki, Helsinki, Finland Komulainen, K., Airaksinen, J., Savelieva, K. et al. Network dynamics of depressive symptoms in antidepressant medication treatment: secondary analysis of eight clinical trials. Mol Psychiatry (2020).
https://doi.org/10.1038/s41380-020-00884-3
5806 GSK Melancholic depression and response to lamotrigine for the treatment of acute bipolar depression: a pooled analysis of five randomized controlled trials Dr. Evyn Peters Department of Psychiatry, College of Medicine, University of Saskatchewan Peters, E.M., Lodhi, R.J., Zhang, Y., Li, H., & Balbuena, L. (2021). Lamotrigine for acute bipolar depression: an exploratory item-level analysis. Brain and Behavior, 1- 6. https://doi.org/10.1002/brb3.2222


5815 GSK Examining statistical methods to allow comprehensive evaluation and presentation of adverse event data in randomised controlled trials Rachel Phillips Imperial College London Phillips R, Cro S, Wheeler G, Bond S, Morris T P, Creanor S et al. Visualising harms in publications of randomised controlled trials: consensus and recommendations BMJ 2022
DOI:10.1136/bmj-2021-068983
5819 GSK The immunogenicity and efficacy of pneumococcal vaccines: a systematic review and network meta-analysis of individual participant data Merryn Voysey University of Oxford Shuo Feng, Julie McLellan, Nicola Pidduck, Nia Roberts, Julian P.T. Higgins, Yoon Choi, Alane Izu, Mark Jit, Shabir A. Madhi, Kim Mulholland, Andrew J. Pollard, Beth Temple, Merryn Voysey Immunogenicity and seroefficacy of 10-valent and 13-valent pneumococcal conjugate vaccines: a systematic review and network meta-analysis of individual participant data eClinicalMedicine, Volume 61, 2023.
https://doi.org/10.1016/j.eclinm.2023.102073.
5862 GSK Impact of belimumab on antiphospholipid antibodies in patients with Systemic Lupus Erythematosus Katerina Chatzidionysiou 1st Department of Propaedeutic and Internal Medicine, Laiko Hospital, Medical School, National and Kapodistrian University of Athens, Greece Chatzidionysiou K, Samoli E, Sfikakis PP, et alEffect of belimumab treatment on antiphospholipid antibody levels: post-hoc analysis based on two randomised placebo-controlled trials in systemic lupus erythematosus Annals of the Rheumatic Diseases 2020;79:304-307.

http://dx.doi.org/10.1136/annrheumdis-2019-216367
5886 GSK Efficacy of belimumab in patients with active systemic lupus erythematosus and concomitant antiphospholipid syndrome Pier Luigi Meroni Istituto Auxologico Italiano, IRCCS, Laboratory of Immunorheumatology, Milan, Italy. Bettiol A, Pregnolato F, Sciascia S, et alAssociation of subcutaneous belimumab and long-term antimalarial treatment reduces antiphospholipid antibodies levels in systemic lupus erythematosus: post-hoc analysis of a randomised placebo-controlled trial—comment on: ‘Effect of belimumab treatment on antiphospholipid antibody levels: post-hoc analysis based on two randomised placebo-controlled trials in systemic lupus erythematosus' by Chatzidionysiou et alAnnals of the Rheumatic Diseases Published Online First: 04 August 2020. doi: 10.1136/annrheumdis-2020-218377
5895 ViiV Pharmacogenetics of Interaction between Efavirenz and Dolutegravir David W. Haas, MD Vanderbilt University Medical Center Nashville, Tennessee David W Haas, MD, Edward P Acosta, PharmD, Implications of Efavirenz Pharmacogenetics when Switching from Efavirenz- to Dolutegravir-containing Antiretroviral Regimens, Clinical Infectious Diseases, , ciaa975,

https://doi.org/10.1093/cid/ciaa975
5995 Novartis An investigation of clinical outcome measures in PPMS to inform the design of investigator initiated clinical trials. Marcus Koch MD PhD University of Calgary, Calgary, Alberta, Canada Koch MW, Mostert J, Repovic P, Bowen JD, Strijbis E, Uitdehaag B, Cutter G. Smoking, obesity, and disability worsening in PPMS: an analysis of the INFORMS original trial dataset. J Neurol. 2022 Mar;269(3):1663-1669.
DOI: 10.1007/s00415-021-10750-z

Koch MW, Mostert J, Zhang Y, Wolinsky JS, Lublin FD, Strijbis E, Cutter G. Association of Age With Contrast-Enhancing Lesions Across the Multiple Sclerosis Disease Spectrum. Neurology. 2021 Sep 28;97(13):e1334-e1342.
DOI: 10.1212/WNL.0000000000012603
6042 Eisai, GSK, Sanofi An investigation into unblinded sample size re-estimation methodology in clinical trials Julia Edwards The University of Sheffield Edwards, Julia (2020) Unblinded Sample Size Re-estimation in Randomised Controlled Trials. PhD thesis, University of Sheffield.
http://etheses.whiterose.ac.uk/28647/
6044 GSK, Sanofi Is there a Difference in the Immune Response, Efficacy, and Safety of Seasonal Influenza Vaccine in Males and Females? - A Meta-Analysis. Caroline Quach Department of Microbiology, Infectious diseases & Immunology and CHU Sainte-Justine Research Center, Université de Montréal, Montréal, QC, Canada Kiely M, Tadount F, Lo E, et al Sex differences in adverse events following seasonal influenza vaccines: a meta-analysis of randomised controlled trials J Epidemiol Community Health (2023).
DOI: 10.1136/jech-2023-220781
9134 ViiV Population pharmacokinetic analysis of interaction between dolutegravir and rifampin Gary Maartens Department of Medicine University of Cape Town Health Sciences Faculty A.N. Kawuma, R.E. Wasmann, K.E. Dooley, M. Boffito, G. Maartens, P. Denti Population Pharmacokinetic Model and Alternative Dosing Regimens for Dolutegravir Coadministered with Rifampicin Antimicrobial Agents and Chemotherapy (2022) vol 66
https://doi.org/10.1128/aac.00215-22
10141 GSK Impact of rotavirus genotype and local rotavirus gastroenteritis incidence on Rotarix vaccine efficacy estimates: a multi-site pooled analysis of individual-level clinical trial data Avnika B. Amin Department of Epidemiology, Rollins School of Public Health, Emory University Amin AB, Tate JE, Waller LA, Lash TL, Lopman BA. Monovalent Rotavirus Vaccine Efficacy Against Different Rotavirus Genotypes: A Pooled Analysis of Phase II and III Trial Data. Clin Infect Dis. 2023 Feb 8;76(3)
DOI: 10.1093/cid/ciac699
11229 GSK Exploration of the Hospital Recovery Scale as an endpoint to assess clinical improvement in hospitalized influenza patients Wilbert van Duijnhoven Janssen R&D Belgium W. van Duijnhoven, I. Van Dromme, S. Haesendonckx, J. Witek, L. Leopold The Hospital Recovery Scale: A clinically useful endpoint in patients hospitalized with influenza Contemporary Clinical Trials vol 123 (2022)
https://doi.org/10.1016/j.cct.2022.106952
11230 Sanofi A systematic review of prognostic biomarkers in idiopathic pulmonary fibrosis Prof Gisli Jenkins University of Nottingham Fasihul A. Khan, Iain Stewart, Gauri Saini, Karen A. Robinson, R. Gisli Jenkins; A systematic review of blood biomarkers with individual participant data meta-analysis of matrix-metalloproteinase-7 in IPF; European Respiratory Journal (2021)
http://doi.org/10.1183/13993003.01612-2021
11236 GSK Systemic Lupus Erythematosus Disease Activity Score (SLE-DAS) validation: post-hoc analysis of the BLISS-52 and BLISS-76 phase III trials. Luís Inês Professor of Rheumatology and Head of the CHUC Lupus Clinic, Rheumatology Department, Centro Hospitalar e Universitário de Coimbra. Coimbra, Portugal Professor of Rheumatology at Faculty of Health Sciences, University of Beira Interior. Covilhã, Portugal Jesus D, Larosa M, Henriques C, et al. Systemic Lupus Erythematosus Disease Activity Score (SLE-DAS) enables accurate and user-friendly definitions of clinical remission and categories of disease activity. Annals of the Rheumatic Diseases 2021;80:1568-1574.
doi: 10.1136/annrheumdis-2021-220363
11280 GSK Antibody response to primary and booster immunization in infants born to mothers immunized with pertussis-containing vaccines during pregnancy versus unimmunized women: a systematic review and meta-analysis Dr. Manish Sadarangani University of British Columbia, Canada Abu-Raya B, Maertens K, Munoz FM, Zimmermann P, Curtis N, Halperin SA, Rots N, Barug D, Holder B, Kampmann B, Leuridan E, Sadarangani M. The Effect of Tetanus-Diphtheria-Acellular-Pertussis Immunization During Pregnancy on Infant Antibody Responses: Individual-Participant Data Meta-Analysis. Front Immunol. 2021 Jul 6;12:689394.
doi: 10.3389/fimmu.2021.689394.
PMID: 34305922; PMCID: PMC8299947.

Abu-Raya B, Maertens K, Munoz FM, Zimmermann P, Curtis N, Halperin SA, Rots N, Barug D, Holder B, Rice TF, Kampmann B, Leuridan E, Sadarangani M. Factors affecting antibody responses to immunizations in infants born to women immunized against pertussis in pregnancy and unimmunized women: Individual-Participant Data Meta-analysis. Vaccine. 2021 Oct 22;39(44):6545-6552. Epub 2021 Sep 29.
doi: 10.1016/j.vaccine.2021.09.022.
PMID: 34598822.
11283 GSK Association between Vaginal Infection and Cervical Non-HPV16/18 Infection in Women after Bivalent HPV Vaccination Fanghui Zhao Cancer Hospital, Chinese Academy of Medical Sciences Shang-Ying Hu, Sabrina H Tsang, Feng Chen, Qin-Jing Pan, Wen-Hua Zhang, Ying Hong, Joshua N Sampson, Allan Hildesheim, Fang-Hui Zhao, Aimée R Kreimer, Association Between Common Vaginal Infections and Cervical Non-Human Papillomavirus (HPV) 16/18 Infection in HPV-Vaccinated Women, The Journal of Infectious Diseases, Volume 223, Issue 3, 1 February 2021, Pages 445-451
https://doi.org/10.1093/infdis/jiaa384
11298 GSK Development of personalised predictive models for the evolution of atopic dermatitis severity in response to treatment Reiko Tanaka Department of Bioengineering, Imperial College London Duverdier A, Hurault G, Thomas KS, Custovic A, Tanaka RJ. Evaluation of measurement errors in the Patient-Oriented Eczema Measure (POEM) outcome. Clin Exp Allergy 2024; 54: 207-215
DOI:10.1111/cea.14441
11340 GSK Towards precision medicine in Chronic Obstructive Pulmonary Diseases: predicting individual treatment response and general outcomes in SUMMIT Wim Janssens University Hospitals Leuven Department of Respiratory Diseases Research Laboratory BREATHE, Department CHROMETA, KU Leuven Herestraat 49 3000 Leuven Belgium Verstraete K, Gyselinck I, Huts H, et al Estimating individual treatment effects on COPD exacerbations by causal machine learning on randomised controlled trials Thorax 2023;78:983-989.
DOI: http://dx.doi.org/10.1136/thorax-2022-219382
11347 GSK Estimation of primary, secondary and composite effects of the RTSS/AS01 vaccine Paul Milligan London School of Hygiene&Tropical Medicine Yin Bun Cheung, Xiangmei Ma, K.F. Lam, Paul Milligan. Estimation of the primary, secondary and composite effects of malaria vaccines using data on multiple clinical malaria episodes Vaccine, Vol38, Issue 32, (2020) p.4964-4969
https://doi.org/10.1016/j.vaccine.2020.05.086.

11384 GSK Human papillomavirus(HPV) vaccine efficacy and immunogenicity in women with existing HPV infections Fanghui Zhao National Cancer Center & Cancer Hospital,Chinese Academy of Medical Sciences Wen T-M, Xu X-Q, Zhao X-L, et al. Efficacy and immunogenicity of AS04-HPV-16/18 vaccine in females with existing cervical HR-HPV infection at first vaccination: A pooled analysis of four large clinical trials worldwide. Int J Cancer. 2024; 1-15
doi:10.1002/ijc.34882
11485 Novartis, Sanofi Comorbidity and Clinical Trials of Disease-Modifying Therapies in Multiple Sclerosis Amber Salter The University of Texas Southwestern Medical Center Investigating the Prevalence of Comorbidity in Multiple Sclerosis Clinical Trial Populations Amber Salter, Samantha Lancia, Kaarina Kowalec, Kathryn C. Fitzgerald, Ruth Ann Marrie NEUROLOGY Volume 102 March 12, 2024
DOI: https://doi.org/10.1212/WNL.000000000020913
11492 Eisai, Novartis Meta-analysis of efficacy of cholinesterase inhibitors on individual neuropsychiatric symptoms in Alzheimer's disease, Parkinson's disease and dementia with Lewy bodies. Iris Sommer UMCG d'Angremont E, Begemann MJH, van Laar T, Sommer IEC. Cholinesterase Inhibitors for Treatment of Psychotic Symptoms in Alzheimer Disease and Parkinson Disease: A Meta-analysis. JAMA Neurol. June 26, 2023.
DOI: 10.1001/jamaneurol.2023.1835
11504 GSK Translating randomized controlled trial data to an external target population: a secondary analysis of data from the RV1 trial in South Africa and Malawi Denise St. Jean University of North Carolina at Chapel Hill, Department of Epidemiology Transporting monovalent rotavirus vaccine efficacy estimates to an external target population: a secondary analysis of data from a randomized controlled trial in Malawi D.T.St Jean, J.K.Edwards, E.T.Rogawski McQuade, P.Thompson, J.C.Thomas, S.Becker-Dreps.
Journal of Epidemiology & Infection, 2023

11560 GSK Emotional blunting by mechanism of second-generation antidepressants: comparing bupropion and serotonin reuptake inhibitors Dr. Evyn Peters University of Saskatchewan, Department of Psychiatry E.M. Peters, L. Balbuena, R. J. Lodhi Emotional blunting with bupropion and serotonin reuptake inhibitors in three randomized controlled trials for acute major depressive disorder Journal of Affective Disorders (vol 318) (2022)
https://doi.org/10.1016/j.jad.2022.08.066
11627 GSK Validation of the diabetes Chronic Kidney Disease (CKD) and Heart Failure (HF) model in the HARMONY Outcomes trial Lizheng Shi Tulane University School of Public Health and Tropical Medicine Lin, Y, Shao, H, Shi, L, Anderson, AH, Fonseca, V.
Predicting incident heart failure among patients with type 2 diabetes mellitus: The DM-CURE risk score. Diabetes Obes Metab. 2022; 24( 11): 2203- 2211
doi:10.1111/dom.14806
11714 Novartis The Difference Between Cystatin C- and Creatinine- Based Assessment of Renal Function in Heart Failure Patients: Insights From PARADIGM-HF and RELAX-AHF Alberto Pinsino Columbia University Medical Center A.Pinsino, M.R. Carey, S.Husain et al The Difference Between Cystatin C- and Creatinine-Based eGFR in Heart Failure With Reduced Ejection Fraction: Insights From PARADIGM-HF American Journal of Kidney Diseases April 20, 2023
DOI: https://doi.org/10.1053/j.ajkd.2023.03.005
11927 GSK EVALUATION OF THE EFFECTS OF CARDIOVASCULAR DRUGS ON SURVIVAL AND EXACERBATIONS IN PEOPLE WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE Marie Fisk University of Cambridge & Cambridge University Hospitals NHS Foundation Trust
Summary Results:

Link to Aspirin Chapter.pdf
https://clinicalstudydatarequest.com/Documents/Aspirin%20Chapter.pdf

Link to Yuan PhD thesis.pdf
https://clinicalstudydatarequest.com/Documents/Yuan%20PhD%20thesis.pdf

11950 GSK, Novartis Making real world predictions for clinical outcomes in Relapsing-Remitting Multiple Sclerosis Georgia Salanti Institute of Social and Preventive Medicine, University of Bern, Bern, Switzerland E.M. Peters, L. Balbuena, R. Lodhi Emotional blunting with bupropion and serotonin reuptake inhibitors in three randomized controlled trials for acute major depressive disorder,
Journal of Affective Disorders vol 318 (2022)
https://doi.org/10.1016/j.jad.2022.08.066
11995 GSK Study to Evaluate Plasmodium vivax malaria pharmacometric Responses in blood and liver staGes to Eight AminoquinoliNe Treatments (SARGEANT) Nicholas J White Mahidol Oxford Tropical Medicine Research Unit Watson JA, Commons RJ, Tarning J, Simpson JA, Llanos Cuentas A, Lacerda MVG, Green JA, Koh GCKW, Chu CS, Nosten FH, Price RN, Day NPJ, White NJ. The clinical pharmacology of tafenoquine in the radical cure of Plasmodium vivax malaria: An individual patient data meta-analysis. Elife. 2022 Dec 6;11:e83433.
DOI: 10.7554/eLife.83433
12095 GSK Interpersonal sensitivity and response to selective serotonin reuptake inhibitors Dr. Evyn Peters, MD, FRCPC, MSc Department of Psychiatry, University of Saskatchewan Evyn M. Peters, Orhan Yilmaz, Cindy Li, Lloyd Balbuena Interpersonal sensitivity and response to selective serotonin reuptake inhibitors in patients with acute major depressive disorder Journal of Affective Disorders, Volume 355, 2024, p.422-425
DOI: https://doi.org/10.1016/j.jad.2024.03.112.

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