Clinical trials generate systematic and vital information about the efficacy, safety and quality of medical interventions. However, there has been much discussion about the degree to which trial results and the underpinning data are currently made available to researchers outside of the team that conducted the original trial.
The primary aims of this study, commissioned by the Wellcome Trust in April 2014, were to develop an understanding of the types of novel clinical research that may be possible using individual participant data (IPD) from clinical trials, and to develop case studies of existing and future examples of such research and its benefits. The study also aimed at assessing the potential level of demand for a broader access model for such clinical trial data, and whether there are appreciable differences between the academic and commercial research communities in terms of needs and use of clinical trial data.
We examined the history and set-up of existing data sharing initiatives, their current research use, and impacts achieved. We also gathered views regarding the current barriers to research using IPD and the need for broader access to IPD, via a central access point or otherwise, by consulting researchers from commercial and non-commercial entities, staff of clinical trial data repositories, and individuals affiliated with clinical research such as representatives of funding organisations and patient groups. Further questions gauged the perceived level of importance of various characteristics of a future access model, in order to allow researchers from the academic, non-profit, and industrial sectors to contribute data and share research benefits, while protecting patient privacy and respecting the wishes of trial participants regarding re-use of their data.
Technopolis Group provided a set of recommendations, based on the evidence gathered, to contribute to discussions about the key mechanisms and practicalities that would need to underlie a broader access model for clinical trial data. It is hoped that increasing access to clinical trial data will contribute to fully exploiting existing research data for the benefit of the scientific community and, ultimately, the patient.
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