|About||We are a science-led global healthcare company with a special purpose: to help people do more, feel better, live longer.|
|Studies Listed for Sharing||
|When Studies are Available for sharing||Within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data. (Implementation of this policy change began in April 2016). Where a study has not been accepted for publication and publication is no longer being progressed, it will also be included.|
|Additional Conditions for Access||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. Where additional data security and governance requirements can be met by researchers (in addition to those specified in the standard Data Sharing Agreement) GSK may provide access to the relevant data subset outside the data access system.|
|What information will be provided||Where available, the following anonymized 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 were completed in or after 2007.
🗹 Protocols with any amendments. This describes the objectives, design, methodology, statistical considerations, and organization of a clinical study. The protocol is part of the appendices of the clinical study report.
🗹 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. 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).
|Questions or enquiries||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.|
|Data Request Review Process||Consistent with expectations of good scientific practice, researchers can request access to our studies by providing a research proposal with a commitment to publish their findings. The research proposal is reviewed by an independent review panel. This is a team of external independent experts who were appointed by the Wellcome Trust.|
|Review Criteria for Data Requests||
|Clinical Study Register or Website||https://www.gsk-studyregister.com/|