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Funders Specific Details:

  • Studies listed

    Phase 1 to 4 interventional clinical studies in participants which have been completed after January 2010.

    Clinical trials will also be listed for Phase 1-4 interventional clinical studies in participants relating to terminated compounds. Terminated compounds are unapproved medicines for which clinical development is completely terminated.

    We are in the process of compiling the list of studies and will regularly update this list to add further studies.

  • Exceptions

    Clinical studies where data labels and/or supporting documents are not in English.

    Small studies, single-center studies, clinical studies of rare diseases or other studies where anonymisation of these data is difficult to achieve.

    Studies where clinical data have been collected subject to legal, contractual or consent provisions that prohibit transfer to third parties, or in case of substantial conflicts of interest, data access under this policy may be precluded.

    For products with a co-research, co-development or co-marketing/co-promotion agreement, it is recognized that the responsibility for disclosure is dependent on the agreement between parties. We will endeavor to gain agreement to list studies in these circumstances.

    Where use of the clinical data disclosure leads to commercial competitive risk.

  • When studies are listed

    Once the study is completed and the PI who has been funded by CRUK/MRC/Gates/Wellcome agrees to list and share clinical trial data through CSDR.

    Once a product is approved for the given formulation in the given indication or the development is completely terminated and the results from the study have been accepted for publication, the study will be listed.

  • Additional conditions for data access

    When participants agreed to take part in clinical studies they gave permission (through informed consent) to share their data for further scientific research.

  • Datasets and documents provided

    Where available, the following anonymised patient level data and information is provided:

    Raw dataset. This is the dataset collected for each patient in the clinical study.

    Analysis-ready dataset. This is the dataset used for analysis.

    Protocols with any amendments or addenda. This describes the objectives, design, methodology, statistical considerations, and organization 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.

    Statistical analysis plan. This describes methods of analysis and procedures for data handling that used for the study report.

    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), the European Medicines Agency (EMA) and Pharmaceuticals and Medical Devices Agency (PMDA). Appendices that contain no patient relevant data (e.g. audit certificates or manuals from providers of various diagnostic services) as well as individual patient level data (e.g. narratives) are not included.

    Documents will be redacted to protect personal data of study participants, study personnel, and employees, and to protect ' commercially confidential information, including intellectual property rights.

    Anonymisation standard. This describes method used to anonymise the data.

  • Enquiries

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

  • Access to study documents without patient-level data

    Researchers can enquire about access to clinical study documents only (without patient level data, such as the Clinical Study Report, study protocol or data analysis plan) by completing the online enquiry form.

  • Review criteria for enquiries

    Whether the studies have been published or accepted for publication and whether they researched authorized medicines or terminated compounds. It is policy to provide access to patient level data only after authorization or termination of the medicine and acceptance of the study for publication in the scientific literature.

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

    Whether considers that there are any practical constraints to providing access to the data.

    The resources (costs) for 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 may turn down requests on this basis.

  • Anonymisation standards
    Available upon request
  • Clinical study register

    Clinical trials that we fund are registered on ClinicalTrials.gov, on the ISRCTN registry or on another register listed on the WHO International Clinical Trials Registry Platform (ICTRP).