Under new WHO guidelines researchers will be required to report the findings of their clinical trials within 12 months and publish in a peer-reviewed journal within 24 months.
Another important feature of the WHO statement is its call for public disclosure of results from older, unreported clinical trials.
In a paper published in PLOS Medicine that explains the rationale behind the new statement Vasee Moorthy and colleagues from the WHO say it is unethical to conduct human research without publication and dissemination of the results of that research. In particular, withholding results may subject future volunteers to unnecessary risk.
“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,” they say.
In an accompanying Perspective article Ben Goldacre, from the Centre for Evidence-Based Medicine, Oxford University and co-founder of the AllTrials campaign, says the is a “landmark position statement” but cautions that “delivering definitive change… will require more than positive statements and good intentions.
“[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.”