The American Medical Association (AMA) has joined the AllTrials initiative, giving the campaign for clinical trial data transparency a formidable ally with the largest physician membership in the U.S.
“The AMA joining AllTrials represents an incredible step forward for clinical trial transparency, and the U.S. arm of this initiative,” says Lauren Quattrochi, PhD, director of AllTrials USA.
The AMA’s support shows that the issue of clinical trial transparency is vitally important for practicing physicians and the integrity of medicine, she tells IRB Advisor.
“Doctors need all the information when they are making treatment decisions for their patients, and this is impossible if the data on current medications are compromised by the failure to register trials and report results,” says Quattrochi, who directs the initiative as a project of Sense About Science, based in Brooklyn, NY. “We can work toward accomplishing this level of transparency if those involved in making the daily, patient-tailored treatment decisions are well-informed.”
The AMA’s Medical Student Section called for enhanced clinical trial transparency and support of the AllTrials initiative at the association’s 2015 Interim House of Delegates meeting. The delegates adopted a policy during the meeting to support the timely dissemination of clinical trial data, improved enforcement deadlines for sharing these results, and expanded registration for clinical trials to improve clinical practice and policy. After getting the green light from its board of trustees, the AMA recently joined the AllTrials initiative.
“The AMA strongly supports improving the timeliness and accessibility of clinical trial data to reduce the duplication of research and help inform future research — ultimately improving health outcomes for patients,” AMA President Steven J. Stack, MD, said in a statement.
Founded in the U.K., the AllTrials campaign — a varied group of patient advocates, medical associations, and academia — brought their crusade for clinical trial transparency to the United States in July 2015. They argue that many clinical trials, involving hundreds of thousands of patients, have never reported results. AllTrials calls for all past and present clinical trials to be registered and their full methods and summary results reported.
“In the U.S., we are keen to build on the evident enthusiasm among medical students for trial transparency,” Quattrochi says. “Medical students are our next generation of doctors, and their expertise will help move their respective fields forward — but not unless they have the data they need to make appropriate decisions. By focusing their attention on this issue now, we believe these doctors will help build a more transparent future for medicine.”
In addition to a total blackout of trial results, another concern is that data that shows efficacy or benefit in one portion of a clinical trial may be revealed independently. AllTrials is not seeking regulation or government mandates for clinical trial data disclosure. Instead, the group has adopted a strategy of activism, historical inevitably, and coercion that urges the medical industry to get on board.
“There is no excuse for clinical trials not to be registered and their results reported in a timely manner,” Quattrochi says. “Clinical trial participants would benefit from their data [being] accessible. Even if the trial does not alleviate or cure their ailment, the outcome may help others down the road.”
Withholding trial data from physicians could also contribute to needless duplication in research with little medical benefit.
“Moreover, how do we as researchers know that we haven’t missed an opportunity to explore a novel therapy or discover a new application for a drug if previous work has been kept unpublished?” she says.
AMA joins 641 patient advocacy groups, professional societies, medical organizations, and thousands of patients worldwide in supporting the global AllTrials campaign.
“We have barely scratched the surface for what is possible,” Quattrochi says. “America is just one country where clinical trial data has been left on the cutting room floor. We aim to expand into every major country and assist their medical, research, and patient communities into building a better infrastructure to capture and responsibly share data.”
AMA joins other U.S. physician-based groups that have endorsed AllTrials, including the American College of Physicians and the American Academy of Family Physicians.
“Our next step here in the U.S. is to continue to build a dialogue around clinical trial transparency among patient advocacy groups, scientific societies, academic institutions, and pharmaceutical researchers,” she says. “We can collectively act as a catalyst for a cultural shift that will promote all trial results to be shared for the greater good.”