WIKIMEDIA, VMENKOVTen years ago, following on the creation of its International Clinical Trials Registry Platform, the World Health Organization (WHO) called for all researchers to deposit clinical trial details into freely accessible registries before initiating any study, and to make any results publicly available trial completion. This week, the WHO reiterated its position, noting that sharing information related to clinical trials “is a scientific, ethical and moral responsibility.”
Details such as the enrollment, timeframe, and objectives of clinical trials should be made public before the studies begin, according to the WHO, and should be updated if changed. Following the completion of a trial, the organization has called for researchers to submit their results for publication in peer-reviewed journals within 12 months.
“Failure to publicly disclose trial results engenders misinformation, leading to skewed priorities for both R&D and public health interventions,” Marie-Paule Kieny, WHO assistant director general for health systems and innovation, said in an April 14 statement. “It creates indirect costs for public and private entities, including patients themselves, who pay for suboptimal or harmful treatments.”
“Delivering definitive change will require more than positive statements and good intentions,” Ben Goldacre of the University of Oxford wrote in a PLOS Medicine opinion piece. Goldacre proposed an audit system to ensure participation and accountability. “As with all audit cycles throughout clinical practice this data must be acted on, with those who are guilty of research misconduct in withheld trials exposed to public scrutiny and local performance management; investigations automatically triggered by their professional regulators; and denied access to further trial participants,” he wrote.