A clinical trial’s effectiveness depends on its subjects. Because of the strict criteria for who can participate, researchers have battled for years to fill clinical trials and recruit enough varied patient populations for results to reflect the general community.
An international group of experts and decision-makers has produced new suggestions on how to establish eligibility standards for lung cancer clinical trials in an effort to involve a broader and more varied population.
The group was led in part by David Gerber, M.D., 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The suggestions, which were just released in JAMA Oncology, provide the first framework of a future FDA draft guidance on lung cancer clinical trials that will hopefully make it simpler to include more patients.
“This paper 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 Hematology/Oncology Division at UTSW. “If these changes are successful, they could make clinical trials for lung cancer as well as other cancers more powerful and more representative.”
To accurately assess how a new medication will function among patients of all races and ethnicities, it is imperative to make sure that people from diverse backgrounds participate in clinical studies. However, approximately 11% of cancer trial participants currently identify as members of a racial or ethnic minority, and only around 5% of all cancer patients participate in clinical trials.
For cancer patients, taking part in clinical trials necessitates not only the desire to attempt an experimental treatment but also the time and effort to learn about the trial, sign up for it, and frequently attend further testing or clinic appointments.
Numerous experts concur that the limited participation of underrepresented minorities in clinical trials is mostly due to the difficult, erratic, poorly communicated, and excessively tight qualifying standards for cancer clinical trials.
This paper 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. If these changes are successful, they could make clinical trials for lung cancer as well as other cancers more powerful and more representative.
Professor Dr. David Gerber
“So many clinical trials never finish enrollment, close prematurely, or don’t recruit a population that lets researchers generalize the results,” Dr. Gerber said. “I think there’s widespread recognition that eligibility criteria have become too stringent.”
The LUNGevity Foundation organized a roundtable discussion with specialists from academia, business, and regulatory organizations to address this issue in one disease subtype advanced non-small cell lung cancer (NSCLC).
The group put out a prioritized list of eligibility groups that ought to be mentioned in the summaries of all NSCLC clinical trials, along with suggested standards for each group. Some recommendations were more permissive than what was usually required for NSCLC trial eligibility in the past.
The researchers suggested, for example, that the majority of patients with prior or ongoing malignancies, the majority of patients with brain metastases, and the majority of patients with minor liver impairment all of whom would have likely been disqualified from trials in the past be included in trials anyway.
The group also recommended that these categories be presented in a way that is simple to search for on public websites that advertise clinical trials. The FDA will soon publish a draft of its advice on NSCLC clinical studies and invite public feedback before completing it.
To standardize eligibility standards for clinical trials of various cancer types, other interdisciplinary committees have already met. If the new recommendations are successful, clinical trials should be simpler to enroll in and provide more thorough and timely information on novel cancer treatments, according to Dr. Gerber.
“If you can involve more patients in clinical trials, you’re more likely to complete those trials quickly. That’s going to 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 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.
