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Sponsor Specific Details: Roche

  • Studies listed

    All phase 2 and 3 clinical studies or phase 4 studies that were used as part of a regulatory approval or where the product was terminated from development (all indications) with a first patient enrolled as of 1 January 1999 onwards.

    Roche is in the process of compiling a list of studies in scope. Roche will regularly update this list to add studies going back to January 1999. In the event that you cannot see a specific study in the Roche list, an Enquiry Form can be submitted to confirm the availability of the specific study.

  • Exceptions

    Clinical studies with a sample size of less than 50 patients or in rare diseases. This is because anonymisation of these data is more difficult to achieve. For these studies Roche will assess the feasibility of anonymisation as part of the review of enquiries.

    Phase 4 clinical studies conducted for non-registrational purposes or local affiliate studies.

    Clinical studies that are NOT free from any binding and related legal agreement.

  • When studies are listed

    After the medicine studied has been approved by regulators for the indication in both the US and EU or terminated from development (all indications).

    18 months after completion of the study report (to enable a publication to be submitted).

  • Additional conditions for data access

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

    For future studies (2014 onwards) patients will be asked to give permission for broader research so other research may be possible with data from these studies.

    A condition of providing the data is that the external requester seeks publication of their research results. Roche are to be provided with a copy of the manuscript after journal submission for information. Roche may chose to provide the requester with comments on the document as a courtesy, but the external requester is not obliged to incorporate any feedback resulting from this review.

  • Datasets and documents provided

    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.

    Analysis-ready dataset. This is the dataset used for Roche's analysis.

    The number of datasets (raw and derived) for each study will be limited to the minimum necessary to reasonably achieve the scientific objectives of the research proposal (e.g. if the research is focusing on efficacy, adverse event datasets would not be provided).

    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) Roche 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. This is the report of efficacy and safety data from the study. It forms the basis of submissions to regulatory authorities such as the Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Appendices which include patient level data are not included as these data are provided in the datasets Roche provide.
  • Enquiries

    Researchers can enquire about the availability of data from Roche clinical studies that are not listed on the site before they submit a research proposal.

  • Access to study documents without patient-level data
  • Review criteria for enquiries

    Whether the studies have been included in a completed regulatory filing (EU and US) or whether the study is from a terminated development program (all indications). It is Roche policy to provide access to patient level data after either criteria has been achieved and it is >18 months after the study report was completed.

    Whether Roche have the legal authority to provide the data. For example, Roche may not have the legal authority because the medicine has been out-licensed to another company.

    Whether Roche consider it feasible to anonymise the data without compromising the privacy and confidentiality of research participants. For example, anonymisation of data from studies of rare diseases is more difficult to achieve and will be reviewed on a case-by-case basis.

    Whether Roche consider that there are any practical constraints to providing access to the data. For example, imaging data, notes from patient interviews or genomic data will not be provided unless and until all relevant patients provide explicit consent.

    The resources (costs) for Roche to retrieve data and documents from repositories and archives, anonymise data, and redact personally identifiable information from relevant documents. In some cases, particularly for older studies, the costs could be considerable and Roche may turn down requests on this basis.

  • Anonymisation standards
  • Clinical study register