Clinical trial data sharing has challenges, such as ensuring patient confidentiality and appropriate re-use of data by third parties.
Initiatives such as ClinicalStudyDataRequest.com – whereby pharmaceutical trial sponsors provide anonymised individual patient data to researchers whose proposals are assessed by an Independent Review Panel - demonstrate that there are feasible systems for secure, controlled sharing of individual patient data from industry trials.
In the following pages, we highlight some key initiatives and repositories which may provide tools and guidance for data sharing in the academic clinical trial field. Some of these are not discipline specific and are described as “generalist”; then Section 3 and Section 4 respectively outline initiatives and good practice guidelines supporting data sharing in the Clinical Research field. It is the responsibility of the investigators to ensure that any repositories/standards/tools they intend to use are appropriate for the nature of the research envisaged.