Journal of IiME Volume 9 Issue 1 positive statements require practical implementation. The solution is likely to lie in simple audit, providing better data for individual accountability. This can be delivered at low cost through a routine audit cycle to identify completed but unreported trials on all registries, with public performance tables that will incentivise trialists to ensure their registry entries reflect their compliance. Local audit will facilitate data-checking and ensure local accountability. As with all audit cycles throughout clinical practice this data must be acted on, with those who are guilty of research misconduct in withheld trials exposed to public scrutiny and local performance management; investigations automatically triggered by their professional regulators; and denied access to further trial participants. Lastly, doctors and patients can act on withheld data exposed by audit and consider avoiding treatments—or indeed whole companies—where there is clear evidence that the data on those interventions is comparatively unreliable. These are simple processes that should have been integrated into the information ecosystem of evidence-based medicine from the outset. We cannot make truly informed decisions when vitally important information on the methods and results of clinical trials is routinely withheld, and yet we have tolerated this simple, fixable, pervasive flaw in evidence-based medicine for many decades. The doctors and patients of the future may well look back on this phenomenon with amazement, much as we look back on mediaeval bloodletting. Author Contributions Wrote the paper: BG. Agrees with manuscript results and conclusions: BG. BG has read, and agrees that he meets, ICMJE criteria for authorship. References 1.Moorthy VS, Karam G, Vannice KS, Kieny M-P. Rationale for WHO's New Position Calling for Prompt Reporting and Public Disclosure of Interventional Clinical Trial Results. PLoS Med. May 2015 2015 Apr 14; 12(4): e1001819. doi: 10.1371/journal.pmed.1001819. 2.Hartung DM, Zarin DA, Guise J-M, McDonagh M, Paynter R, Helfand M. Reporting discrepancies between the ClinicalTrials.gov results database and peer-reviewed publications. Ann Intern Med. 2014 Apr 1;160(7):477–83. doi: 10.7326/M13-0480. pmid:24687070 3.Anderson ML, Chiswell K, Peterson ED, Tasneem A, Topping J, Califf RM. Compliance with Results Reporting at ClinicalTrials.gov. N Engl J Med. 2015 Mar 12;372(11):1031–9. doi: 10.1056/NEJMsa1409364. pmid:25760355 4.Ross JS, Tse T, Zarin DA, Xu H, Zhou L, Krumholz HM. Publication of NIH funded trials registered in ClinicalTrials.gov: cross sectional analysis. BMJ. 2012;344:d7292. doi: 10.1136/bmj.d7292. pmid:22214755 5.Jones CW, Handler L, Crowell KE, Keil LG, Weaver MA, Platts-Mills TF. Non-publication of large randomized clinical trials: cross sectional analysis. BMJ. 2013 Oct 29;347:f6104. doi: 10.1136/bmj.f6104. pmid:24169943 6.Simes RJ. Publication bias: the case for an international registry of clinical trials. J Clin Oncol. 1986 Oct 1;4(10):1529–41. pmid:3760920 7.Mathieu S, Boutron I, Moher D, Altman DG, Ravaud P. Comparison of Registered and Published Primary Outcomes in Randomized Controlled Trials. JAMA. 2009 Sep 2;302(9):977–84. doi: 10.1001/jama.2009.1242. pmid:19724045 8.Boutron I, Dutton S, Ravaud P, Altman DG. Reporting and Interpretation of Randomized Controlled Trials With Statistically Nonsignificant Results for Primary Outcomes. JAMA. 2010 May 26;303(20):2058–64. doi: 10.1001/jama.2010.651. pmid:20501928 9.Wieseler B, Wolfram N, McGauran N, Kerekes MF, Vervölgyi V, Kohlepp P, et al. Completeness of Reporting of Patient-Relevant Clinical Trial Outcomes: Comparison of Unpublished Clinical Study Reports with Publicly Available Data. PLoS Med. 2013 Oct8;10(10):e1001526. doi: 10.1371/journal.pmed.1001526. pmid:24115912 10.Zarin DA, Tse T, Williams RJ, Califf RM, Ide NC. The ClinicalTrials. gov results database—update and key issues. N Engl J Med. 2011;364(9):852–60. doi: 10.1056/NEJMsa1012065. pmid:21366476 11.Riveros C, Dechartres A, Perrodeau E, Haneef R, Boutron I, Ravaud P. Timing and Completeness of Trial Results Posted at ClinicalTrials.gov and Published in Journals. PLoS Med. 2013 Dec3;10(12):e1001566. doi: 10.1371/journal.pmed.1001566. pmid:24311990 12.ICMJE. ICMJE | About ICMJE | Clinical Trials Registration. 2014.http://www.icmje.org/about-icmje/faqs/clinical-trialsregistration/. Accessed 20 March 2015. 13.House of Commons Science and Technology Select Committee. Inquiry into Clinical Trials Transparency, note 305. 2013. http://www.publications.parliament.uk/pa /cm201314/cmselect/cmsctech/104/10407.htm#note305. Accessed 20 March 2015. From http://www.plosmedicine.org/article/comments/info%3Adoi% 2F10.1371%2Fjournal.pmed.1001821 Invest in ME (Charity Nr. 1114035) www.investinme.org Page 16 of 57
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