Rationale for WHO's New Position Calling for Prompt Reporting and Public Disclosure of Interventional Clinical Trial Results

Abstract

On April 14, 2015, the World Health Organization (WHO) published a new statement on the public disclosure of clinical trial results (S1 Text) [1].The WHO statement not only re-affirms the ethical imperative of clinical trial results reporting, it also defines reporting timeframes, calls for results-reporting of older but still unpublished trials, and outlines steps to improve linkages between clinical trial registry entries and their published results.This updates and expands WHO's 2005 statement that "the registration of all interventional trials is a scientific, ethical, and moral responsibility" [2].WHO's 2005 statement called for all interventional clinical trials to be registered.Subsequently, there has been an increase in clinical trial registration prior to the start of trials.This has enabled tracking of the completion and timeliness of clinical trial reporting.There is now a strong body of evidence showing failure to comply with results-reporting requirements across intervention classes, even in the case of large, randomised trials [3][4][5][6][7].This applies to both industry and investigator-driven trials.In a study that analysed reporting from large clinical trials (over 500 participants) registered on clinicaltrials.govand completed by 2009, 23% had no results reported even after a median of 60 months following trial completion; unpublished trials included nearly 300,000 participants [3].Among randomised clinical trials (RCTs) of vaccines against five diseases registered in a variety of databases between 2006-2012, only 29% had been published in a peer-reviewed journal by 24 months following study completion [4].At 48 months after completion, 18% of trials were not reported at all, which included over 24,000 participants.In another study, among 400 randomly selected clinical trials, nearly 30% did not publish the primary outcomes in a journal or post results to a clinical trial registry within four years of completion [5].The Declaration of Helsinki and other statements have outlined the compelling reasons why interventional clinical trials should be reported in a timely fashion [8][9][10].In brief, not reporting clinical trial results is likely to lead to dissemination bias.This bias has the following major adverse consequences:• It affects understanding of the scientific state of the art.• It leads to inefficiencies in resource allocation for both research and development and financing of health interventions.• It creates indirect costs for public and private entities, including patients themselves, who pay for suboptimal or harmful treatments.• It potentially distorts regulatory and public health decision making.