Table 1

Main initiatives aimed at developing principles and recommendations for IPD sharing

A report by Technopolis to the Wellcome Trust, 201591 This described the status of existing data sharing initiatives and current research practices, and generated recommendations. The study was addressed to a funder, developed primarily by UK researchers and focused more on key considerations of data access.
A report from the Committee on Strategies for Responsible Sharing of Clinical Trial Data, in the USA, 201514 Endorsed by the Institute of Medicine, this report provided guiding principles and a framework for activities and strategies. It tried to balance the interests of all stakeholders and considered commercial as well as non-commercial trials. As pointed out in the report, many practical issues and a detailed roadmap were not discussed in detail.
A report from the Working Group on Transparency and Registration of the Nordic Trial Alliance, 201515 This report provided best practices and a dense set of recommendations for the Nordic countries, covering not only IPD but also registration and the publication of summary results and full reports.
Good Practice Principles for Sharing IPD from publicly funded clinical trials, by the MRC Hub for Trials Methodology Research, 201516 17 Endorsed by Cancer Research UK, the MRC Methodology Research Programme Advisory Group, the Wellcome Trust and the Executive Group of the UKCRC Trials Units Network. The UKā€™s National Institute for Health Research has confirmed it is supportive of the application of these practices. The document provides detailed recommendations from the UK viewpoint.
Principles for data sharing, by pharmaceutical industry bodies (PHRMA, EFPIA), 201420 These are principles for data sharing (rather than detailed guidelines) from commercial trials, together with a public commitment to making data available for sharing.
  • EFPIA, European Federation of Pharmaceutical Industries and Associations; IPD, individualĀ participant data; MRC, Medical Research Council (UK); PHRMA, Pharmaceutical Research and Manufacturers of America; UKCRC, UK Clinical Research Consortium.