DALLAS – August 4, 2022 – A clinical trial is as powerful as its participants. For years, researchers have struggled to fill clinical trials and enroll sufficiently diverse groups of patients for results that reflect the wider population, in part because of strict guidelines about who can participate.
David Gerber, MD
In an effort to include a larger and more diverse population, an international team of researchers and policymakers has written new recommendations on how to determine eligibility criteria for lung cancer clinical trials. The group was led in part by David Gerber, MD, Associate Director for Clinical Research at UT Southwestern’s Harold C. Simmons Comprehensive Cancer Center, along with representatives from the Food and Drug Administration (FDA), National Cancer Institute, European Medicines Agency, pharmaceutical companies and the LUNGevity Foundation.
The recommendations, published today in JAMA Oncologyprovide the first publicly available outline of upcoming FDA guidelines for lung cancer clinical trials that are expected to make it easier to admit more patients.
“This article is the public’s first look at the FDA’s proposed changes to how we determine who can participate in a lung cancer clinical trial,” said Dr. Gerber, professor of internal medicine in the Department of Hematology/Oncology of UTSW. “If these changes are successful, they could make clinical trials for lung cancer and other cancers more powerful and representative.”
Ensuring that people from different backgrounds participate in clinical trials is essential to properly evaluate how a new treatment will work in patients of all races and ethnicities. But today, only about 5% of all cancer patients enroll in a clinical trial, and only 11% of cancer clinical trial participants identify as a racial or ethnic minority.
For patients with cancer, participating in clinical trials requires not only the decision to try an experimental treatment, but also the time and energy spent understanding the trial, participating in it, and often attending additional tests or clinic appointments. Many researchers agree that complicated, inconsistent, poorly explained and too strict eligibility requirements to participate in a cancer clinical trial exacerbate this problem and are a major reason for the low number of underrepresented minorities in clinical trials.
“So many clinical trials never terminate enrollment, close prematurely, or recruit a population that allows researchers to generalize the results,” said Dr. Gerber. “I think there is widespread recognition that the eligibility criteria have become too strict.”
To address this issue in one cancer subtype – advanced non-small cell lung cancer (NSCLC) – the LUNGevity Foundation hosted a roundtable with experts from academia, industry and regulatory authorities. The team compiled a prioritized list of eligibility categories to be included in the descriptions of all NSCLC clinical trials and recommended criteria for each category. Some suggestions were milder than what is typically included in previous NSCLC trial eligibility criteria; for example, the team recommended that most patients with previous or concurrent cancers, most patients with brain metastases, and most patients with mild hepatic impairment — all of whom would likely have been excluded in the past — should still be included in studies.
The team also suggested clearly listing these categories on public websites that advertise clinical trials in an easily searchable format.
The FDA will release draft guidelines for clinical trials of NSCLC in the near future and hold a public comment period before finalizing them. Other interdisciplinary teams have already met to standardize eligibility requirements for clinical trials with other cancer types.
If the new guidelines are effective, said Dr. Gerber that clinical trials will likely be easier to complete and provide more complete and timely data on new cancer interventions.
“If you can involve more patients in clinical trials, you are more likely to complete those trials quickly. That will lead to new treatments more quickly,” he said.
Other authors of the article include Harpreet Singh and Erin Larkins of the FDA; Andrea Ferris and Upal Basu Roy of LUNGevity Foundation; Patrick M. Forde of Johns Hopkins University; and Wendy Selig of WS Collaborative LLC.
dr. Gerber holds the David Bruton, Jr. Professorship in Clinical Cancer Research.
About UT Southwestern Medical Center
UT Southwestern, one of the nation’s premier academic medical centers, integrates cutting-edge biomedical research with exceptional clinical care and education. The institution’s faculty has received six Nobel Prizes and includes 26 members of the National Academy of Sciences, 17 members of the National Academy of Medicine, and 14 Howard Hughes Medical Institute Investigators. Its full-time faculty of more than 2,900 members is responsible for pioneering medical advances and is committed to quickly translating science-based research into new clinical treatments. UT Southwestern physicians provide care in more than 80 specialties to more than 100,000 hospitalized patients, more than 360,000 emergency care cases, and oversee nearly 4 million outpatient visits per year.