The US Institute of Medicine (IoM) is seeking input from researchers, clinical-trial sponsors, patients, advocacy groups, other stakeholders and the general public on a discussion framework for a study on ‘responsible’ sharing of clinical-trial data.

The IoM’s Committee on Strategies for Responsible Sharing of Clinical Trial Data expects to release a final report, to include findings and recommendations on strategies and practical approaches to trial data-sharing, in late 2014.

Along with the US National Institutes of Health, the Food and Drug Administration and charities such as The Wellcome Trust, the Medical Research Council (both UK-based) and the Doris Duke Charitable Foundation, the study is funded by a number of pharmaceutical multinationals including AbbVie, AstraZeneca, Bayer, Bristol-Myers Squibb, Eli Lilly, GlaxoSmithKline, Johnson & Johnson, Merck & Co., Novartis and Sanofi-Aventis.

Dr Joanne Waldstreicher, chief medical officer at Johnson & Johnson, is on the IoM’s committee, together with representatives of academia, patient groups, the US-based Genetic Alliance and the New England Journal of Medicine.

Last year the biopharmaceutical industry’s Chief Medical Officers’ Forum welcomed plans by the IOM, the health arm of the US National Academy of Sciences, to conduct a consensus study on responsible sharing of clinical-research data.

The initiative followed a workshop on data-sharing hosted by four groups within the IOM – the Forum on Drug Discovery, Development and Translation; the Forum on Neuroscience and Nervous System Disorders; the National Cancer Policy Forum; and the Roundtable on Translating Genomic-Based Research for Health – in October 2012.

Public workshops

The IoM will now hold two public workshops on clinical-trial data-sharing in Washington, DC on 3-4 February and 5 May 2014.

Comments on the discussion framework may be submitted to the committee at either of these workshops, or through a project website (preferably by 24 March 2014) at:

The discussion framework presents the committee’s preliminary guiding principles for data sharing. These include respecting individual trial participants whose data are shared; maximising the benefits of sharing to research participants and society while minimising harm; increasing public trust in clinical trials; and sharing data in a manner that “enhances fairness”. 

The committee has also identified key elements of data/data-sharing activities that it plans to examine in the course of the study, including which data might be shared; who provides or receives shared data; and whether access to data will be controlled.

Specific comment is sought on the following topics within the discussion framework:

  • Global Implementation and Practical Consideration – for example, how can clinical trial data be shared in a global con­text, taking into account differing national regulations on patient privacy, data exclusivity, intellectual property, etc?  

  • Timing and Prioritisation – e.g., what would be the rationale for placing a higher priority on certain types of data or analyses? Should any agreed measures apply retroactively to trials started before the data-sharing programme was launched?

  • Mitigating Risks – e.g., how to minimise the risks to patients and public health of disseminating findings from “invalid analyses” of shared clinical-trial data? What measures should be deployed to minimise privacy and confidentiality risks to trial participants?  

  • Enhancing Incentives e.g., what incentives and protections are needed to encourage clinical-trial sponsors and clin­ical investigators to continue conducting trials, but without undue restrictions on sharing of certain types of data?  

  • Measuring Impact e.g., what would be appropriate outcome measures to assess the usefulness of different models for sharing clini­cal-trial data sharing, and how could these be used to guide improvements in data sharing practices?