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Center for Global Research Data

Our Members

GSK

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 
  • Global interventional clinical studies which evaluate medicines that were ongoing or started after the formation of GSK (December 2000).
  • Local interventional studies which evaluate medicines that started in or after 2013. 
  • GSK Consumer Healthcare studies with a primary completion date from January 1, 2018.  
  • Other studies where data are provided to researchers. 
Exceptions
  • Clinical studies where data labels and/or supporting documents are not in English. 
  • Clinical studies of rare diseases. This is because anonymization of these data is more difficult to achieve. For these studies, GSK will assess the feasibility of anonymization as part of the review of enquiries. 
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
  • 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.
Anonymization Standards  
Clinical Study Register or Website   https://www.gsk-studyregister.com/

 

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