Journal of IiME Volume 9 Issue 1 How to Get All Trials Reported: Audit, Better Data, and Individual Accountability Editorial comment: Although Invest in ME share little in common with this author’s views on ME we do feel this article about the publication of research data is useful and would be interesting if applied to the publicly funded PACE Trial, where data has been refused to be released to the public despite Freedom of Information requests. In this week’s PLOS Medicine, the World Health Organization (WHO) publishes a landmark position statement, requiring all trials to make their methods and results available [1]. This represents important progress on a longstanding and global structural problem that has a clear, negative impact on patient care. The best currently available evidence shows that the methods and results of clinical trials are routinely withheld from doctors, researchers, and patients [2–5], undermining our best efforts at informed decision making. From this point forward, whenever the methods and results of a trial are withheld, doctors, patients, researchers, campaigners, and health care providers will be able to point at an unambiguous statement from WHO. Delivering definitive change, however, will require more than positive statements and good intentions. The first quantitative data demonstrating publication bias in clinical trials—and clear call for trial registries—was published in 1986 [6]. Anyone withholding the methods and results of a clinical trial is already in breach of multiple codes and regulations, including the Declaration of Helsinki, various promises from industry and professional bodies, and, in many cases, the United States Food and Drug Administration (FDA) Amendment Act of 2007. Indeed, a recently published cohort study of trials in clinicaltrials.gov found that more About the Author Ben Goldacre Senior Clinical Research Fellow, Centre for EvidenceBased Medicine, Department of Primary Care Health Sciences, University of Oxford, Oxford, United Kingdom Research Fellow, Department of Non-communicable Disease Epidemiology, London School of Hygiene & Tropical Medicine, London, United Kingdom DOI: 10.1371/journal.pmed.1001821 Citation: Goldacre B (2015) How to Get All Trials Reported: Audit, Better Data, and Individual Accountability. PLoS Med 12(4): e1001821. doi:10.1371/journal.pmed.1001821 Published: April 14, 2015 Copyright: © 2015 Ben Goldacre. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited Funding: No specific funding was received for this work. BG is currently funded by the Wellcome Trust and the Laura and John Arnold Foundation. Competing interests: BG is a co-founder of AllTrials.net, which campaigns internationally for all trials to be registered with their full methods and results available. BG receives academic funding from the Wellcome Trust, and the Laura and John Arnold Foundation, to work on various problems, including publication bias. BG receives income from popular science books and public speaking on problems in science, including publication bias. Provenance: Commissioned; not externally peer reviewed Invest in ME (Charity Nr. 1114035) www.investinme.org Page 12 of 57 May 2015

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