WHO statement on public reporting of clinical trial results announced
PLOS
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."
Essay
Funding: There is no specific funding for this work.
Competing Interests: The authors have declared that no competing interests exist.
Citation: 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
Author Affiliations:
World Health Organization, SWITZERLAND
IN YOUR COVERAGE PLEASE USE THIS URL TO PROVIDE ACCESS TO THE FREELY AVAILABLE PAPER:
http://www.plosmedicine.org/article/info%3Adoi%2F10.1371%2Fjournal.pmed.1001819
Contact:
Vasee Moorthy
World Health Organization
+41 79 540 6919
moorthyv@who.int
Perspective Article
Funding: No specific funding was received for this work. BG is currently funded by the Wellcome Trust and the Laura and John Arnold Foundation.
Competing Interests: BG has read the journal's policy and has the following conflicts: BG is a cofounder of AllTrials.net, which campaigns internationally for all trials to be registered with their full methods and results available. BG receives academic funding from the Wellcome Trust, and the Laura and John Arnold Foundation, to work on various problems, including publication bias. BG receives income from popular science books and public speaking on problems in science, including publication bias.
Citation: Goldacre B (2015) How to Get All Trials Reported: Audit, Better Data, and Individual Accountability. PLoS Med 12(4): e1001821. doi:10.1371/journal.pmed.1001821
Author Affiliations:
University of Oxford, UNITED KINGDOM
London School of Hygiene & Tropical Medicine, UNITED KINGDOM
http://www.
PLOS
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."
Essay
Funding: There is no specific funding for this work.
Competing Interests: The authors have declared that no competing interests exist.
Citation: 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
Author Affiliations:
World Health Organization, SWITZERLAND
IN YOUR COVERAGE PLEASE USE THIS URL TO PROVIDE ACCESS TO THE FREELY AVAILABLE PAPER:
http://www.plosmedicine.org/article/info%3Adoi%2F10.1371%2Fjournal.pmed.1001819
Contact:
Vasee Moorthy
World Health Organization
+41 79 540 6919
moorthyv@who.int
Perspective Article
Funding: No specific funding was received for this work. BG is currently funded by the Wellcome Trust and the Laura and John Arnold Foundation.
Competing Interests: BG has read the journal's policy and has the following conflicts: BG is a cofounder of AllTrials.net, which campaigns internationally for all trials to be registered with their full methods and results available. BG receives academic funding from the Wellcome Trust, and the Laura and John Arnold Foundation, to work on various problems, including publication bias. BG receives income from popular science books and public speaking on problems in science, including publication bias.
Citation: Goldacre B (2015) How to Get All Trials Reported: Audit, Better Data, and Individual Accountability. PLoS Med 12(4): e1001821. doi:10.1371/journal.pmed.1001821
Author Affiliations:
University of Oxford, UNITED KINGDOM
London School of Hygiene & Tropical Medicine, UNITED KINGDOM
http://www.
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