WHO: Release All Research Data!

In a further sign of an epochal change in medical research, the World Health Organization has renewed its call for researchers to report all the results from clinical trial research. While there has been great deal of discussion about why clinical trial registration and reporting is an ethical imperative for academia and industry, the argument has only slowly begun to resolve into concrete steps, many of which are either current or prospective, meaning they only affect current or new research.

Which is why one of the most significant aspects of the WHO statement is its insistence that clinical trial data from the past be brought out into the sunlight: “Unreported clinical trials conducted in the past are to be disclosed in a publicly available, free to access, searchable clinical trial registry.” The rationale, explained in an article in PLOS Medicine, is that it is not just unethical to engage patients in clinical trials and then not to reveal the results, it could expose future patients to unnecessary risk, waste resources, and distort health regulation and recommendation.

Asked about the WHO statement, Richard Stephens a cancer patient and clinical trial participant told Sense About Science that it was “hugely welcome.”

“Patients,” he said, “who choose to take part in clinical trials believe that by doing so, we are helping other patients in the future. We do not expect the knowledge to be kept secret or the help for others to be denied. It is immoral to recruit patients to clinical trials and then not report or share the results. We hope the call from the WHO will be taken up by everyone who can help uncover hidden information.”

BEUC, a consumer umbrella group which represents 40 independent national consumer organisations from 31 European countries in Brussels, called the new WHO statement “a landmark move for consumers.”

In addition to its position on older clinical trials, the WHO statement calls for improvements in current trial registration, peer-review publication within 12 months of the trial being completed and open access to the paper, with a 24-month limit for journals that do not provide open access. The WHO also called for the inclusion of Trial ID/Registry data with all publication—a small but vital technical component of making trials searchable through medical databases.