Sharing and reuse of individual participant data from clinical trials: principles and recommendations (Ohmann et al., 2017)

Ohmann C, Banzi R, Canham S, et al - Ohmann C, Banzi R, Canham S, et al. Sharing and reuse of individual participant data from clinical trials: principles and recommendationsBMJ Open 2017;7:e018647 - 2017
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  • Data management
  • Data sharing and secondary use
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10.1136/bmjopen‑2017‑018647

This BMJ Open article sets out a consensus framework for responsible sharing of individual participant data from clinical trials, focusing on non‑commercial studies. It reviews key scientific, ethical, legal and operational issues and then proposes practical ways to address them, based on a structured consensus process involving researchers, patient representatives, methodologists, information technology experts, funders and research infrastructures.

At its core are ten overarching principles that define what any individual participant data sharing framework should include. These cover: promoting and resourcing data sharing; using broad consent appropriately; de‑identifying data; applying data and metadata standards; implementing proportional access models; operating transparent request and review procedures; sharing supporting trial documents; choosing suitable repositories; and providing discovery‑level metadata. The ten principles are translated into 50 concrete recommendations grouped under seven topics:

  • Making data sharing a reality (culture, incentives, funding, infrastructure)
  • Consent for data sharing (broad consent wording, participant rights and expectations)
  • Protection of trial participants (de‑identification, pseudonymisation, re‑identification risk assessment)
  • Data standards (interoperability, data formats, metadata, use of standards such as CDISC where appropriate)
  • Rights, types and management of access (access models, governance, data use agreements, stewardship)
  • Data management and repositories (data preparation, repository maturity, long‑term preservation and governance)
  • Discoverability and metadata (public, structured metadata to support findability and reuse).

Investigators can use the ten principles as a high‑level checklist when designing their data sharing strategy, then turn to the detailed recommendations in the relevant sections (for example consent, de‑identification, access models or repositories) when drafting protocols, consent forms, data management plans or institutional policies. A glossary of key terms and references to related initiatives help readers link these recommendations to wider international work on clinical trial data sharing.

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