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A new policy laid out by the U.S. Department of Health and Human Services is aimed at improving clinical trials.
Clinical trials are not currently operating to their full potential, says Francis Collins, M.D., Ph.D., National Institutes of Health (NIH) director. So, the U.S. Department of Health and Human Services (HHS) announced new requirements for registering and recording trial results online, hoping that this will drive more patient participation and increase information sharing.
With fewer than 5 percent of patients with cancer participating in clinical trials, Vice President Joe Biden, who is directing the federal Cancer Moonshot effort, says the time is ripe for such an improvement. In fact, a number of trials fail because they do not meet their enrollment targets and are therefore unable to provide meaningful results.
One big problem has been that patients and practitioners alike have difficulty locating the appropriate trials. Collins explains that the new federal policy should make this information more accessible: “It tells you what the trial is about, what kind of individuals would qualify, what exclusions, who’s the person to contact … all that information is there.”
Additionally, all trials must be registered in the clinicaltrials.gov database within 21 days of the first participant enrolling. Third-party sites will also be able to spread the information to their constituencies through a new application programming interface, allowing patient advocacy groups, cancer centers, and researchers to build web applications and search engines to improve access to trial information.
Aside from increasing patients’ ability to find trials, having more information can help researchers in designing their own trials, avoiding duplicate trials and be able to focus instead on unmet needs.
The new rule also has requirements once a trial has been completed. For NIH trials, Collins reported, “we know about a third of them never end up in publication,” and thus, the results of those trials cannot be found by interested parties. Now, results must be published within 12 months of collecting the last data point which will help to inform both clinicians and patients on medical decisions. Moreover, it is important that not just trials with positive results are published and accessible to the research community and other stakeholders.
Nearly 900 public comments helped to inform the new rule. Although it doesn’t account for smaller trials such as phase 1 and feasibility studies, the NIH enacted a complementary rule that will cover smaller trials as well as behavioral studies.
The goal of the new policy is for “increased access to information and transparency about the research” that NIH supports, according to Collins. “We believe people have interests and rights to see everything that’s being supported through their taxpayer money.” The NIH is the largest public funder of clinical trials in the United States, investing more than $3 billion annually.
FDA Commissioner Robert M. Califf, M.D., added in a statement that the people who volunteer for clinical trials should have “their participation honored by ensuring that the existence of trials and their results are available to all patients and their healthcare providers, as well as researchers.”
The effort also involves comprehensive compliance and enforcement provisions. Aside from potential civil monetary penalties, institutions receiving federal funding that do not adequately register and report may have clinical trial funding withheld.
In a commentary published in the Journal of the American Medical Association, authors from the NIH, including Collins, note that despite the impressive research gains NIH-funded clinical trials have achieved, “fundamental changes are needed to reflect science and society’s movement to increase efficiency, accountability, and transparency in clinical research.”
These authors and others spearheading the initiative hope this new guidance covering the “lifespan” of the clinical trial, will improve the way in which investigators develop ideas for new trials, how NIH reviews and selects them for funding, and ensure that trial results are shared “broadly and rapidly.”
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