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A new approach to determining admission could increase enrollment and diversity. — ScienceDaily

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A clinical trial is only as strong as its participants. For years, researchers have struggled to fill clinical trials and enroll sufficiently diverse groups of patients so that the results are relevant to the wider population, in part because of strict guidelines about who can participate.

In an effort to reach a larger and more diverse population, an international team of researchers and policymakers has written new guidelines on how to determine eligibility criteria for lung cancer clinical trials. The panel was led in part by David Gerber, MD, associate director of clinical research at UT Southwestern’s Harold S. Simmons Cancer Center, as well as representatives from the Food and Drug Administration (FDA), the National Cancer Institute, the European Medicines Agency, pharmaceutical company and the LUNGevity Foundation.

Guidelines published today in JAMA Oncologyoffer the first publicly available outline of the FDA’s upcoming draft guidelines for lung cancer clinical trials, which are expected to facilitate the inclusion of more patients.

“This article is the first public look at the FDA’s proposed changes to how we determine who can participate in lung cancer clinical trials,” said Dr. Gerber, professor of internal medicine in the UTSW Division of Hematology/Oncology. “If successful, these changes could make clinical trials for lung cancer, as well as other cancers, more powerful and representative.”

Ensuring that people from different walks of life join clinical trials is key to properly evaluating how a new treatment will work among patients of all races and ethnicities. But today, only about 5% of all cancer patients participate in clinical trials, and only 11% of cancer clinical trial participants identify themselves as racial or ethnic minorities.

For cancer patients, participating in clinical trials requires not only the decision to try an experimental treatment, but also time and energy spent understanding the trial, participating in it, and often attending additional testing or clinic appointments. Many researchers agree that complex, inconsistent, poorly explained, and overly stringent cancer clinical trial enrollment requirements exacerbate this problem and are a major reason for the low numbers of underrepresented minorities in clinical trials.

“So many clinical trials never complete enrollment, close prematurely, or fail to recruit, allowing researchers to generalize the results,” Dr. Gerber said. “I think it’s widely recognized that the eligibility criteria have become too strict.”

To address this challenge in one cancer subtype—advanced non-small cell lung cancer (NSCLC)—the LUNGevity Foundation convened a roundtable discussion with experts from academia, industry, and regulatory agencies. The team developed a prioritized list of eligibility categories that should be included in the descriptions of all NSCLC clinical trials and recommended criteria for each category. Some proposals were more lenient than what was typically included in previous eligibility criteria for NSCLC trials; for example, the team recommended that most patients with previous or concurrent cancers, most patients with brain metastases, and most patients with mild liver dysfunction—all of whom may have been excluded in the past—still be included in the trial.

The team also suggested that these categories be clearly stated on public websites that advertise clinical trials in a searchable format.

The FDA will soon publish draft guidelines for NSCLC clinical trials and conduct a public comment period before finalizing them. Other multidisciplinary groups have already convened to standardize clinical trial entry requirements for other types of cancer.

If the new guidelines are effective, Dr. Gerber said, clinical trials will likely be easier to complete and provide more complete and timely data on new cancer interventions.

“If you can get more patients into clinical trials, you’re more likely to complete those trials quickly. That will lead to new treatments faster,” 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 of Johns Hopkins University; and Wendy Selig of WSCollaborative LLC.

Dr. Gerber holds the David Bruton Jr. Professorship in Clinical Cancer Research.

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