The World Health Organization has called for the results of clinical trials to be made publicly available within a year of trial completion, ScienceInsider reports.
In a statement, the WHO says that this move could help to ensure that the best available evidence underlies the use of drugs, medical devices, and vaccines.
"[I]t is unethical to conduct human research without publication and dissemination of the results of that research," WHO's Marie-Paule Kieny and colleagues write in a PLOS Medicine essay about the organization's position. "In particular, withholding results may subject future volunteers to unnecessary risk."
The agency is calling for clinical trials to be registered with ClinicalTrials.gov, the EU Clinical Trials Register, or other national registries, and that the main findings of a trial should be submitted to a peer-reviewed journal — preferably an open-access one — within a year of the completion of data collection and published within two years, ScienceInsider reports. Key findings, it adds, should also be made available at that clinical trial registry within a year.
A Pharmaceutical Research & Manufacturers of America spokesperson tells Ed Silverman at Pharmalot that "the industry has committed to providing summary results on all trials in patients for marketed drugs and discontinued research programs."
Others say that the WHO's statement doesn't go far enough, Silverman adds. Yale University's Harlan Krumholz says the WHO statement is "articulating an aspiration. But they might suggest a consequence to non-compliance."