The International Committee of Medical Journal Editors (ICMJE) recently proposed the new rules that would require authors to share clinical trial data as a prerequisite for manuscript publication.
According ICMJE, the goal is to improve the benefits to society, which come from these patient’s efforts.
“Participants in clinical trials have voluntarily put themselves at risk on the promise that their efforts would be used to help others,” Dr. Darren Taichman, MD, PhD, Secretary, ICMJE, and Executive Deputy Editor of Annals of Internal Medicine, told OutsoucringPharma.com.
“We have an obligation to keep that promise by ensuring that as much as possible is learned from their selfless efforts. Making the data generated from their efforts available is part of keeping that promise.”
Improving clinical trials
According to Taichman, data sharing has the potential to speed important secondary analyses and the creation of new hypotheses.
“The sharing of de-identified individual patient data will foster the combining of data, when appropriate, from other sources to answer questions any single source would be unable to adequately address,” he says.
It will also help prevent research overlaps that could otherwise be avoided.
Yet, perhaps most importantly to CROs, more readily available information would help assure trial participants that their efforts are being maximized, “thereby helping to address concerns that might otherwise make it difficult to conduct future trials,” adds Taichman.
“It may help identify and/or clarify the risks and benefits of interventions, thereby informing therapeutic choices as well as the conduct of future trials.”
Implementation and enforcement
Implementing a standard of data sharing would be a complex undertaking, and one that would require the efforts of many stakeholders.
Taichman tells us journal editors could help promote data sharing by altering the requirements of the papers they publish.
“To uphold these requirements, editors may check that a data sharing plan has been stated at the time of trial registration,” he says.
“Editors may also check that the authors of submitted manuscripts make clear that the data underlying the results they wish to publish in the journal will be shared according to the previously registered data sharing plan.”
Additionally, if editors learn that data sharing plans aren’t being met, and inquiries are made, they may publish concern notices or even a retraction if appropriate.
“Those who fail to live up to their previously stated data sharing plans may find that editors do not trust their statements in the future,” explains Taichman.
Trial sponsors would also be key – providing resources to allow sharing and enforcing agreements to ensure that obligations are met.
Ultimately, sharing clinical trial data will involve the efforts of many, including study participants, researchers, trial sponsors, journals, and regulatory bodies.
The ICMJE is currently seeking feedback before it adopts any new data sharing requirements. If implemented, it anticipates the requirement would go into effect for clinical trials enrolling participants beginning one year after the ICMJE adopts the new policy.
Comments should be made by April 2016 at www.icmje.org.