Journal of IiME Volume 9 Issue 1 funders, drugs, disease areas, institutions, and investigators. This is highly specific and accountable information that can be used for practical good. Firstly, the very act of creating such data would allow us to name and shame poor performers, and also to reward best practice. Furthermore, those falling behind can identify and learn from those who are successfully meeting their obligations to patients. The results of the audit can also be used to inform medical decision making. While it is unwise for doctors to use their prescription pads to pursue political goals, transparency metrics for an individual drug company are valuable context for interpreting data on the benefits of their products. For example, suppose there are two treatments of apparently equal benefit in meta-analysis, but one is made by a company with a proven track record of complete transparency, with 95% of all information available, while the other is made by a company with clear record of withholding information. The clinically cautious approach is to prescribe the treatment for which the results are more reliable, from the company that is more transparent. May 2015 ●● ● “Withholding the results of clinical trials is unethical and harms patients. Those guilty of such misconduct could be banned from Professional bodies and professional regulators, similarly, can now incorporate the WHO guidance into their codes of conduct and create mechanisms to ensure it is acted upon, for example by opening formal investigations when contacted over concerns around results being withheld by individual researchers or clinicians, and triggering disciplinary action whenever audit shows that the codes have been broken. It is rare, in professional regulation, to have data on transgressions created so rapidly and so unambiguously; it would be wrong to neglect this opportunity to improve standards. Patient groups, lastly, could write open letters to all companies and researchers withholding methods and results of trials on treatments taken by their members, represent their constituencies by holding individuals to reasonable account, and again help improve compliance. conducting further trials on patients” ●● ● The Practicalities of Audit Such audit can be conducted locally, centrally, or ideally, both. Since the recent rejuvenation in policy discussion in the United Kingdom on withheld trials, there have been small local audits Audit data can also be used by ethics committees and institutional review boards (IRBs). Withholding the results of clinical trials is unethical and harms patients. Those guilty of such misconduct could be banned from conducting further trials on patients until their previous trials have been made available. Indeed, even in the absence of such audit data, it would be trivial for all IRBs to ask one simple question of all those applying to conduct a trial: “Have you been involved in any clinical trial, which completed more than 12 months ago, for which the results remain inaccessible?” conducted by various bodies, including sections of the Health Research Authority (as yet unpublished); the National Institute of Health Research (as yet unpublished); the Medical Research Council (to produce an estimate of publication bias for a 2012 UK parliamentary inquiry into trials transparency [13], but as yet unpublished); and an ongoing audit, on which I am a collaborator, covering trials in the University of Oxford. For the latter, alongside our findings, we also plan to publish our practical experiences of conducting the audit, with a boilerplate protocol that can be used by others in order to help make local audits simpler and produce comparable data. Such audits could and should be conducted and published routinely by all government research funders, Invest in ME (Charity Nr. 1114035) www.investinme.org Page 14 of 57
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