Focus on sharing individual patient data distracts from other ways of improving trial transparency.

Journal article

The International Committee of Medical Journal Editors (ICMJE) recently reiterated its commitment to improving trial transparency by sharing individual patient data from randomised trials.1 2 But, although sharing individual patient data contributes to transparency, it is not sufficient by itself. Trial transparency requires a data sharing package, which begins with trial registration and contains other elements such as protocols, summary results, and other trial materials.

Valuable as sharing individual patient data can be,3 discussion about it has hijacked the broader conversation about data sharing and trial transparency.4-6 For example, we identified 76 articles published in the six leading general medical journals that had “data” and “sharing” in their title and were about clinical trials. In 64 (84%) articles, the content was focused on individual patient data and did not mention any of the other components of trial transparency (see appendix on bmj.com).

Much of the discussion has focused on the complexities and practical problems associated with sharing individual patient data and on the processes and systems needed for responsible data sharing.6-9 However, many of the data sharing activities that are needed for trial transparency are not complex. We believe that trying to solve the complex issues around availability of individual patient data should not eclipse or distract from a more pressing problem: the unavailability of even summary data and protocols from all controlled trials. Current estimates are that around 85% of research is avoidably “wasted” because of design flaws, poor conduct, non-publication, and poor reporting.10 Focusing efforts and attention on making individual patient data accessible might paradoxically exacerbate this waste in research. We argue that simpler and more cost efficient activities should be prioritised.

Authors: Hoffmann, T; Glasziou, P; Beller, E; Goldacre, B; Chalmers, I

• Publication status: Published
• Peer review status: Peer reviewed
• Publisher: BMJ Publishing Group
• Journal: BMJ
• Volume: 357
• Pages: j2782
• Publication date: 2017-06-01
• Acceptance date: 2017-02-13
• DOI: 10.1136/bmj.j2782
• EISSN: 1756-1833
• ISSN: 0959-8138
• Pmid: 28642275
• Language: English
• Keywords: Humans; Periodicals as Topic; Access to Information; Information Dissemination; Clinical Trials as Topic