Journal of IiME Volume 9 Issue 1 industry sponsors, and institutions, to help ensure that all trials are reported. Central audit is also desirable, and can be readily worked into existing trial registry workflows. At present, a completed trial without an associated results report on a registry may represent a transgression, but it may also represent an administrative failure. Publishing performance data and acting upon it will incentivise trialists to update their records. Worse still, it is currently impossible to establish on clinicaltrials.gov whether a completed trial has successfully requested an extension for reporting (whatever one might think of such exemptions), because this information is not posted; if data fields on such exceptions are routinely and transparently posted in public onto the database, compliance and transparency rankings can be automatically generated at no cost. When discussing efficiencies, it is important to be clear, however, that the cost of even manual audit is trivial in comparison to the cost of conducting a randomised trial. Producing accessible knowledge for clinical decision making is the key purpose of a trial. Once a trial has been conducted—at great cost—and left unreported, then the small and final marginal cost of making its results available represents better value for money than almost any other step in the research process. What to Do about Past Trials The emphasis by WHO on having access to all trials, from the past as well as the future, is particularly important and welcome. It is clinically highly relevant because the overwhelming majority of prescriptions today are for treatments that came onto the market— and were therefore researched—over the preceding decades rather than the past five years. The question, however, is how to May 2015 ●● ● “We cannot make truly informed decisions when vitally important prioritise access to such information, since there is no sense in resources being deployed on sharing evidence that is no longer relevant to current practice. There are many options. One is to proactively release information, prioritising by some metric of clinical need, such as the number of patients affected; or usage, such as the number of prescriptions issued for that class of treatments; or even a complex model built around power calculations and the likelihood of the withheld data changing the conclusions of the best current systematic review. information on the methods and results of clinical trials is routinely withheld” ●● ● A simpler option, however, is for thorough retrospective registration of clinical trials to act as a “menu” from which doctors, researchers, and patients can request further disclosure of full methods and results, with appropriate transparency around the request and adjudication process. This is an attractive option since registration is low cost, but it does present one previously undocumented challenge. Through the AllTrials.net campaign, we are currently conducting an audit of companies’ policies on trials transparency, to create a Trials Transparency Index. In doing so, we have met a large number of individual companies to ask about gaps in their policies. One recurring theme, on the issue of retrospective registration, is that registries often require detailed administrative information (such as an IRB approval number) that is not readily traceable 20 years after a trial was completed. It may therefore be pragmatic to take a more permissive approach to completeness of certain data fields, with missing items replaced by an explanatory note where absolutely necessary, in preference to a trial not being retrospectively registered at all. Conclusion The position statement from WHO is powerful and welcome, but previous calls for registration were not enough to fix publication bias, and Invest in ME (Charity Nr. 1114035) www.investinme.org Page 15 of 57

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