PLOS Medicine: Rationale for WHO's New Position Calling for Prompt Reporting and Public Disclosure of Interventional Clinical Trial Results 2015-04-29


"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clinical trial results reporting, it also defines reporting timeframes, calls for results-reporting of older but still unpublished trials, and outlines steps to improve linkages between clinical trial registry entries and their published results.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] ... In its statement, WHO has outlined the need for reporting to occur in two modalities. The first is for the main findings of clinical trials to be submitted for publication in a peer-reviewed journal within 12 months of study completion (defined as the final data collection date for the primary outcome measure), with a further 12 months allowed from first submission to publication. Thus the key indicator for tracking will be journal publication of results within 24 months of study completion. Additionally, the key outcomes (defined in the statement) should be made publicly available within 12 months of study completion by posting to the results section of the primary clinical trial registry. If the registry does not allow posting, then the results should be posted on another easily accessible website. Another important feature of the WHO statement is its call for public disclosure of results from older, unreported clinical trials ..."


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Tags: oa.plos oa.who oa.policies oa.clinical_trials oa.medicine oa.biomedicine oa.editorials oa.pharma

Date tagged:

04/29/2015, 07:56

Date published:

04/29/2015, 03:56