Study sponsor: GSK
||Global interventional clinical studies that were ongoing or started after the formation of GSK (December 2000).
All interventional studies that are started in or after 2013.
Other studies where data are provided to researchers.
||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 of GSK Consumer Healthcare products. This is because GSK anticipate more interest from researchers in accessing data from studies of pharmaceutical medicines and vaccines.
|When studies are listed
||Within 6 months of publicationWhere a study has not been accepted for publication and publication is not, or is no longer, being progressed it will be included. of the first scientific paper from the study. (Implementation of this policy change began in April 2016)
|Additional conditions for data 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. For studies GSK conduct from 2013, patients will be asked to give permission for broader research so other research may be possible with data from these studies.
|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 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.
|Access to study documents without patient-level data
||Researchers can access clinical study documents on the GSK Clinical Study Register. If the documents needed are not available on the register then an enquiry can be submitted.
Clinical Study Reports (with personal information removed) are posted onto the GSK Clinical Study Register after the medicine studied has been approved by regulators (first approval) or terminated from development (all indications).
|Review criteria for enquiries
||Whether the studies have been published. It is GSK policy to provide access to patient level data within 6 months of publication of the first scientific paper from the study.
Whether GSK are able to provide the requested data. For example, the majority of non-interventional (or observational) studies use data from third party databases under licence 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 and 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.
|Clinical study register