Sponsor Specific Details: GSK

GSK-sponsored interventional clinical trials conducted with products which: (i) are approved by both the US and EU Health Authorities; or (ii) are approved by either the US or EU Health Authorities when regulatory submissions are not planned in both regions; or (iii) have had development terminated across all indications.

An Enquiry Form can be submitted to confirm the availability of a specific study.

• 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:

• Publishing the results of the primary endpoints, key secondary endpoints
• 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.

Researchers are required to sign a Data Sharing Agreement (DSA). GSK does not anticipate negotiation of the DSA provisions and the researchers are recommended to include an early review of the data sharing provisions included in the DSA template.

This template includes the requirement that as a matter of course GSK receives a non-exclusive royalty-free licence (with the right to sub-licence third parties which GSK collaborates with or engages to perform work on its behalf, as well as GSK’s affiliates), to any IP which arises as a result of the use of GSK’s data.

In addition, the DSA will include requirements to:

• publish the results of the analysis in a scientific journal or pre-print option (e.g., arXiv); and
• open-source release of any software or models (including the model parameters) developed in the research.

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 (provided after first approval or termination of the medicine). 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 GSK provide. To protect research participants' privacy and confidentiality, case narratives are not routinely included. They may be provided where they are needed for a specific research proposal, provided research participants' privacy can be protected.

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.

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.

Clinical Study Reports Synopsis(with personal information removed) are posted on the GSK Study Register after the medicine studied has been approved by regulators (first approval) or terminated from development (all indications).

Whether the studies have been published. It is GSK policy to provide access to patient level data within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study.

Whether GSK are able to provide the requested data. For example, studies that use data from third party databases under license agreements which prevent GSK from providing access to the data. Researchers can access data directly from these third-party databases under similar agreements.

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

Whether GSK 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 or when there is a reasonable likelihood that individual patients could be re-identified. Such requests will be reviewed on a case-by-case basis.

Whether GSK consider that there are any practical constraints to providing access to the data. For example, there may be issues related to the size of databases from genetic studies.

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

Risk-based approach (both qualitative and quantitative) to minimise risk of patient re-identification, derived from the industry best practices from PhUSE, TransCelerate, and Regulatory Guidance from EMA and Health Canada. The overall aim is for a pragmatic balance, ensuring an acceptably low risk of re-identification whilst retaining data utility.

The basic datasets researchers will access may look different from those submitted to regulators or used in publication(s) due to de-identification. As such, in some cases, researchers may not be able to completely duplicate the results of analyses.

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