The World Health Organization (WHO) have announced a new statement on the public disclosure of clinical trial results which updates and expands a previous statement that noted the "the registration of all interventional trials is a scientific, ethical, and moral responsibility." The new statement includes timelines by which researchers are expected to report clinical trials results. In an Essay published in this week's PLOS Medicine Vasee Moorthy and colleagues from the WHO outline the rationale behind the new statement.
A new element in the WHO statement is the definition of timelines for researchers to report the main findings of clinical trial results: by posting to the results section of the primary clinical trial registry within 12 months of study completion, and by publishing within a peer-reviewed journal within 24 months of study completion.
The authors conclude, "WHO calls for ethics committees, regulatory authorities, professional bodies, sponsors, investigators, and funding agencies to act in their jurisdictions to ensure results from all interventional clinical trials are reported and publicly disclosed."
In an accompanying Perspective article, also published in PLOS Medicine, Ben Goldacre, from the Centre for Evidence-Based Medicine, Oxford University and co-founder of the AllTrials campaign, hails the announcement as a "landmark position statement" but cautions that "delivering definitive change... will require more than positive statements and good intentions."
In his article Dr Goldacre sets out practical suggestions around audit and accountability to help ensure appropriate reporting of trial results.
Dr Goldacre notes, "[the statement] represents important progress on a long-standing and global structural problem that has a clear, negative impact on patient care. The best currently available evidence shows that the methods and results of clinical trials are routinely withheld from doctors, researchers, and patients... undermining our best efforts at informed decision making. From this point forward, whenever the methods and results of a trial are withheld, doctors, patients, researchers, campaigners, and health care providers will be able to point at an unambiguous statement from WHO."
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Moorthy VS, Karam G, Vannice KS, Kieny M-P (2015) Rationale for WHO's New Position Calling for Prompt Reporting and Public Disclosure of Interventional Clinical Trial Results. PLoS Med 12(4): e1001819. DOI: 10.1371/journal.pmed.1001819