A proposal to open the results of clinical trials to the public is an encouraging move toward transparency, but the American Heart Association President cautions that how that information is shared and how patients and clinicians are protected from mistakes should be a key part of any change.
The Department of Health & Human Services’ proposed rule would expand the reporting requirements for ClinicalTrials.gov to results on all trials required to register on the database. Reporting requirements are currently only for drugs and devices that are approved, licensed or cleared for use.
The rule also expands what information is accessible. Other than first-phase studies and small feasibility investigations of devices, all trials involving drugs and equipment regulated by the Food and Drug Administration would be subject to the proposed reporting requirement.
A separate proposal by the National Institutes of Health would apply the expanded reporting proposal to all trials funded by NIH. Public comments on that draft policy are being collected until Feb. 19.
“The field of medicine is a complex and fast-moving one,” said Dr. Elliott Antman, AHA president and a senior physician in Brigham and Women’s Hospital’s Cardiovascular Division. He also is professor of medicine at Harvard Medical School. “It’s not possible for each and every investigator to be aware of the results of all trials. So, having some mechanism for providing that information to the scientific community is a laudable goal.”
But Antman said patient anonymity, and companies and scientists who stake their careers and businesses on the products of raw data from years of research should also be protected from having the information used incorrectly.
Hundreds of clinical trials a year test new treatments or diagnostics, compare therapies or help ferret out new knowledge about cures or disease. Thousands of people participate in trials each year.
The objective for any change should be to share information so researchers aren’t duplicating efforts and re-inventing the wheel, said Antman, who has been doing clinical trials for 30 years. It is important to pool the data in ways that create a greater understanding and move toward effective therapies for people with heart disease and stroke, tailored to patients’ needs, he said.
Officials from the NIH and HHS have said the scientific community has a “disappointing record” of sharing clinical trial results, according to a viewpoint published in the Journal of the American Medical Association. The article said a “recent analysis of 400 clinical studies revealed that 30 percent had not shared results through publication or through results reporting in ClinicalTrials.gov within 4 years of completion. This is a serious issue and the proposed rule underscores the intent of NIH to take strong action to promote timely dissemination of clinical trial results.”
In Europe, officials plan on making even more clinical data available. The European Medicines Agency voted to publish clinical reports “that underpin the decision-making on medicines” beginning as early as this summer. Under the policy, users can get general information about data online after a registration process. Those who want the information for academic or non-commercial research provide more detailed information. The EMA is beginning with clinical trial reports, but will include the release of anonymized patient data in coming years.
That is where issues of transparency can become tricky, Antman said. Patients should have a clearer understanding of how their information will be used and safeguards to protect their identity.
Also, companies who have been working for years to bring a device or drug to market, or research investigators and faculty members who invest time and their careers in projects, should be protected from their information being co-opted for commercial use.
“People might do more harm than good by not doing the correct analysis or interpretation,” Antman said. “They might not know how to do it right or have a vested interest in showing the results of the trial as something else, and pick and choose what they analyze.”
One solution could be appointing a person or committee as a “learned intermediary” that would be a kind of clearinghouse for information. That step could review the request and the data to ensure the entity making the information request had the skills and the intent to do a proper analysis.
“The American Heart Association is actively discussing the issue of data sharing and helping set the rules that govern how this is to be done so as to achieve the benefits without putting patients and clinicians who care for them at risk of erroneous information,” Antman said.