The World Health Organization (WHO) today issued a public statement calling for the disclosure of results from clinical trials for medical products, whatever the result. The move aims to ensure that decisions related to the safety and efficacy of vaccines, drugs and medical devices for use by populations are supported by the best available evidence.
“Our intention is to promote the sharing of scientific knowledge in order to advance public health,” said Dr. Marie-Paule Kieny, WHO Assistant Director General for Health Systems and Innovation. “It underpins the principal goal of medical research: to serve the betterment of humanity. Failure to publicly disclose trial results engenders misinformation, leading to skewed priorities for both R&D and public health interventions. It creates indirect costs for public and private entities, including patients themselves, who pay for suboptimal or harmful treatments.”.
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 suggestions around audit and accountability to help ensure appropriate reporting of trial results.
Ben 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.”.
Finally, an interesting blog post has also been written on the WHO statement by BioMed Central. This can be found here.