Sponsor Specific Details: GSK

GSK studies listed on CSDR platform span the period from December 2000 to December 2022.

Starting in 2023, all new data requests are directed to the Vivli platform (www.vivli.org) for further assessment and data sharing.

• Clinical studies where data labels and/or supporting documents are not in English.
• Clinical studies of rare diseases. This is because anonymisation of these data is more difficult to achieve. For these studies GSK will assess the feasibility of anonymisation as part of the review of enquiries.
• Clinical studies where there are substantial practical/technical constraints to providing anonymised data. Examples include where data are not available in electronic format or data are images (e.g., X-Ray/MRI scan) or genetic/genomic data.
• Prematurely terminated trials that have insufficient enrolment/ exposure to warrant analysis may not be listed.

Within 6 months of:

• Publication of the results of the primary endpoints, key secondary endpoints, and safety data; and
• Study product approval in the indication studied (in both US and EU, unless submission is planned for only one of the two regions in which case following approval in either US or EU as applicable, or if submission is not planned for either region first approval in any territory); or asset terminated across all indications.

When patients agreed to take part in GSK clinical studies, they gave permission (through informed consent) to use their data to study the medicine or disease GSK were researching.
Further research must therefore study the medicine or disease that was researched in the original studies.

Research teams must be appropriately qualified and should include a biostatistician to perform analyses.

GSK will provide access to the relevant data subset within a secure data access system. Interim data from clinical trials will generally not be shared by default, although efforts will be made to share such data in long-term, event-driven trials (such as oncology).

Data will not be provided to requesters where there is a potential conflict of interest, data is to be used for a commercial purpose or there is an actual or potential competitive risk.

Data will not be provided to the requesters to construct an AI-ML model that will serve as the foundation for a commercial product or where the codes, scripts, parameters, final model, resulting software are not made accessible to the wider community via an open-source platform like GitHub, regardless of publication.

Requests by a Covered Person for datasets containing U.S. Persons data (as such terms are defined by the U.S. Data Security program ("DSP") pursuant to 28 CFR 202) administered by the United States Department of Justice ("DOJ") will be declined. Furthermore, such requests may be reportable by GSK to the DOJ.

Where available, the following anonymised patient level data and information is provided for each clinical study

☑ Raw dataset. This is the dataset collected for each patient in the clinical study. Patient images from studies are not shared.

☑ Analysis-ready dataset. This is the dataset used for GSK's analysis and will be provided for studies that completed in or after 2007.

☑ Protocol with any amendments. This describes the objectives, design, methodology, statistical considerations, and organisation of a clinical study.

☑ Annotated case report form. This is a blank case report form with descriptions of the data collected and how they are described in the dataset.

☑ Reporting and analysis plan. This describes methods of analysis, procedures for data handling and data displays (figures and tables) GSK used for the study.

☑ Dataset specifications. This is the meta-data which describes the datasets e.g., variable labels, variable descriptions, code lists, formats.

☑ Clinical study report Synopsis: This is a summary of the results.

*The (Anonymized) Full CSR will be made available upon request.

Researchers can enquire about the availability of data from GSK clinical studies that are not listed on the site before they submit a research proposal. GSK may be able to share such data on request, provided it is suitable under GSK's feasibility criteria and additional conditions described above.

Researchers can access clinical study documents on the GSK Study Register. If the documents needed are not available on the register then an enquiry can be submitted to ww.share-support@gsk.com.

The scientific rationale and relevance of the proposed research to medical science or patient care.

The ability of the proposed research plan (design, methods and analysis) to meet the scientific objectives.

Whether the proposal has potential to produce information that will enable identification of individual research participants.

The publication plan for the research.

Any real or potential conflicts of interest that may impact the planning, conduct or interpretation of the research and proposals to manage these conflicts of interest.

The qualifications and experience of the research team to conduct the proposed research review.

Data de-identification will be performed using rule-based approach in accordance with the Safe Harbor method under HIPPA, industry's best standards from PhUSE, TransCelerate, and regulatory guidance from EMA and Health Canada. This is to safeguard the privacy of participants in studies conducted by GSK in line with the International Conference on Harmonization and Good Clinical Practice (ICH/GCP). The overall aim is for a pragmatic balance, ensuring an acceptably low risk of patient re-identification whilst retaining data utility.

The following data protection procedures for personally identifiable information are performed by GSK prior to data sharing:

• Patient identifiers (subject number): Replaced by a recoded value, consistently across all datasets to keep the patient-record relationship.
• Further unique identifiers: Removal of identifiers such as kit numbers and devices.
• Site ID: Replaced by a recoded value.
• Date of birth: Removed.
• Age: Aggregation of Age >89 (Age >89 set to blank for all participants, and create the age category)
• Country: Retained.
• Dates/Times related to study subject: Date offset to +365 to -365 days. Same offset value for all dates of a patient, however different offset per patient. Time remains unchanged.
• Comments, free text, variables containing personally identifiable information (PII), e.g. names, initials: Removed.
• Verbatim term of adverse events, medical history and concomitant medication: Verbatim term will be removed if corresponding dictionary terms are available. If Verbatim term has not been coded, then retain term, review all record for PI.

The basic datasets researchers will access may differ from those submitted to regulator(s) or used in publication(s) due to the de-identification process, potentially preventing researchers from fully replicating the results of GSK's analyses.

https://www.gsk-studyregister.com/