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The power of a clinical trial depends on its participants. For years, researchers have struggled to complete clinical trials and recruit sufficiently diverse patient populations to obtain results that reflect the wider population, in part because of strict guidelines about who can participate.
To engage a larger and more diverse population, an international Team on how to determine eligibility criteria for lung cancer clinical trials. The team was led by David Gerber, MD, associate director of clinical research at the Harold C. Simmons Comprehensive Cancer Center at UT Southwestern, along with the U.S. Food and Drug Administration (FDA), the National Cancer Institute, the European Medicines Agency, pharmaceutical companies, and the LUNGevity Foundation.
These recommendations, published today in JAMA Oncology , provides the first public outline of the forthcoming FDA draft guidance for lung cancer clinical trials, which is expected to make it easier to enroll more patients.
“This paper is the first public look at the FDA’s proposed changes to how we determine who can participate in lung cancer clinical trials,” Prof. Dr. Gerber, MD, Internal Medicine, Department of Hematology/Oncology at UTSW. “If these changes are successful, they could make clinical trials for lung and other cancers more robust and representative.”
Ensuring that people from diverse backgrounds participate in clinical trials is key to properly assessing how new treatments work in patients of all races and ethnicities. But today, only about 5 percent of cancer patients participate in clinical trials, and only 11 percent of cancer clinical trial participants identify as racial or ethnic minorities.
For cancer patients, participating in a clinical trial requires not only a decision to try an experimental treatment, but also time and effort to understand the trial, Participate in trials and often attend additional tests or outpatient appointments. Many researchers agree that this problem is exacerbated by complex, inconsistent, poorly explained, and overly restrictive eligibility requirements to participate in cancer clinical trials, and is underrepresented in clinical trials a key reason for the low number of minorities.
“So many clinical trials never complete enrollment, close prematurely, or fail to recruit populations that allow researchers to summarize results ,” said Dr. Gerber. “I think there’s a general recognition that eligibility criteria have become too strict.”
To address one cancer subtype – advanced stage To address this issue in non-small cell lung cancer (NSCLC), the LUNGevity Foundation convened a roundtable discussion with experts from academia, industry and regulators. The team compiled a prioritized list of eligibility categories that should be included in the description of all NSCLC clinical trials and in the recommended criteria for each category. Some of the recommendations are more lenient than those typically included in previous NSCLC trial eligibility criteria; for example, the team suggested that most patients with previous or concurrent cancer, most patients with brain metastases, and most patients with mild hepatic impairment—all These patients were likely excluded in the past – and should still be included in the trial.
The team also recommends that these categories be clearly listed in an easily searchable format on public websites promoting clinical trials.
FDA to issue draft guidance on clinical trials in NSCLC in near future and hold public comment period prior to finalization . Other interdisciplinary teams have met to standardize eligibility requirements for clinical trials in other cancer types.
If the new guidelines are effective, Dr. Gerber said, clinical trials may be easier to fill out and provide more complete and timely updates Cancer Intervention Data.
“If you can get more patients to participate in clinical trials, you are more likely to complete those trials quickly. This will lead to faster new treatments,” he said.
Other authors of the paper include Harpreet Singh and Erin Larkins of the FDA; Andrea Ferris and Upal Basu Roy of the LUNGevity Foundation; Patrick M. Forde, Johns Hopkins University; and Wendy Selig, WSCollaborative LLC.
MORE INFORMATION: David E. Gerber et al, New Approach to Simplify and Harmonize Cancer Clinical Trials — Standardized Eligibility Criteria, JAMA Oncology (2022). DOI: 10.1001/jamaoncol.2022.1664
Citation : New Recommendations Aim to Make Lung Cancer Clinical Trials More Accessible for Patients ( August 5, 2022), Retrieved August 23, 2022 from https://medicalxpress.com/news/2022-08-aim-ease-patient-access-lung.html
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