Pharmaceutical companies’ policies on access to trial data, results, and methods: audit studyBMJ 2017; 358 doi: https://doi.org/10.1136/bmj.j3334 (Published 26 July 2017) Cite this as: BMJ 2017;358:j3334
- Ben Goldacre, senior clinical research fellow1,
- Síle Lane, director of policy2,
- Kamal R Mahtani, senior clinical research fellow1,
- Carl Heneghan, professor1,
- Igho Onakpoya, research fellow1,
- Ian Bushfield, policy officer2,
- Liam Smeeth, professor3
- 1Centre for Evidence Based Medicine, Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford OX2 6GG, UK
- 2Sense about Science, London, UK
- 3London School of Hygiene and Tropical Medicine, London, UK
- Correspondence to: B Goldacre
- Accepted 3 July 2017
Objectives To identify the policies of major pharmaceutical companies on transparency of trials, to extract structured data detailing each companies’ commitments, and to assess concordance with ethical and professional guidance.
Design Structured audit.
Setting Pharmaceutical companies, worldwide.
Participants 42 pharmaceutical companies.
Main outcome measures Companies’ commitments on sharing summary results, clinical study reports (CSRs), individual patient data (IPD), and trial registration, for prospective and retrospective trials.
Results Policies were highly variable. Of 23 companies eligible from the top 25 companies by revenue, 21 (91%) committed to register all trials and 22 (96%) committed to share summary results; however, policies commonly lacked timelines for disclosure, and trials on unlicensed medicines and off-label uses were only included in six (26%). 17 companies (74%) committed to share the summary results of past trials. The median start date for this commitment was 2005. 22 companies (96%) had a policy on sharing CSRs, mostly on request: two committed to share only synopses and only two policies included unlicensed treatments. 22 companies (96%) had a policy to share IPD; 14 included phase IV trials (one included trials on unlicensed medicines and off-label uses). Policies in the exploratory group of smaller companies made fewer transparency commitments. Two companies fell short of industry body commitments on registration, three on summary results. Examples of contradictory and ambiguous language were documented and summarised by theme. 23/42 companies (55%) responded to feedback; 7/1806 scored policy elements were revised in light of feedback from companies (0.4%). Several companies committed to changing policy; some made changes immediately.
Conclusions The commitments made by companies to transparency of trials were highly variable. Other than journal submission for all trials within 12 months, all elements of best practice were met by at least one company, showing that these commitments are realistic targets.
We thank Tracey Brown, Juliet Stevens, Seb Bacon, Anna Powell-Smith, and Till Bruckner for discussions and support.
Contributors: BG conceived and designed the study. BG and SL analysed the data. IB and SL collected the policy documents. BG, SL, CH, KRM, and IO extracted the data. BG drafted the manuscript. LS supervised the project. All authors contributed to and approved the final manuscript. BG is the guarantor.
Funding: BG is funded by the Laura and John Arnold Foundation to conduct work on research integrity, including this audit. The funder had no involvement in the study design or the decision to submit.
Competing interests: All authors have completed the ICMJE uniform disclosure form at www.icmje.org/coi_disclosure.pdf and declare the following. BG has received research funding from the Laura and John Arnold Foundation, the Wellcome Trust, the NHS National Institute for Health Research (NIHR), the Health Foundation, and WHO; he also receives personal income from speaking and writing for lay audiences on the misuse of science. KRM has received funding from the NHS NIHR and the Royal College of General Practitioners for independent research projects. CH has received grant funding from WHO, the NIHR, and the NIHR School of Primary Care. He is also an advisor to the WHO International Clinical Trials Registry Platform. LS has received research funding and fees from GlaxoSmithKline and AstraZeneca, is a trustee of the British Heart Foundation (BHF), and received research funding from Wellcome, NIHR, the Medical Research Council, BHF, European Union, and a range of charity funders. He is supported by a senior clinical fellowship from Wellcome. SL and IB are employed by Sense about Science, a charity that campaigns on better use of science and evidence; SL coordinates the AllTrials campaign on trial transparency. The views expressed are those of the authors and not necessarily those of any of the funders or institutions mentioned.
Ethical approval: Not required.
Data sharing: Full coding schema, data sheet, and document archive are available at policyaudit.alltrials.net.
Transparency: The manuscripts guarantor affirms that the manuscript is an honest, accurate, and transparent account of the study being reported; that no important aspects of the study have been omitted; and that any discrepancies from the study as planned have been explained.
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