A clinical trial is only as powerful as its participants. For years, researchers have struggled to complete clinical trials and recruit patient groups diverse enough for results to reflect the entire population, in part as a result of strict guidelines on who can participate.
In an effort to include a larger and more diverse population, an international team of researchers and policymakers has drafted new recommendations on how to determine eligibility criteria for clinical trials in lung cancer. The group was led in part by David Gerber, MD, associate director of clinical research at the Harold C. Simmons Thorough Most Cancers Center at UT Southwestern, as well as representatives from the Food and Drug Administration. ), the Countrywide Most cancers Institute, the European Medicines Agency, pharmaceutical industry companies and the LUNGevity Foundation.
The recommendations, published today in JAMA Oncology , offer the first publicly available preview of the FDA’s upcoming draft clinical trial guidelines for lung cancer that should make it easier to include more people.
“This posting is the first public look at the FDA’s proposed changes to how we determine who can participate in a clinical trial for lung cancer,” said Dr. Gerber, Professor of internal medicine at the hema division tology/oncology from UTSW. “If these changes are successful, they could make clinical trials for lung cancer as well as other cancers more powerful and more representative.”
Ensure that people of diverse backgrounds joining clinical trials is essential to properly assess how well a new treatment works in patients of all races and ethnicities. But today, only approximately 5% of all patients with most cancers enroll in a clinical trial, and only 11% of clinical trial participants on most cancers identify as a racial or ethnic minority.
For cancer patients, participation in clinical trials requires not only a decision to try an experimental treatment, but also time and energy spent understanding the trial, enrolling in it, and often attending additional checkups or clinic appointments. Many researchers agree that complicated, inconsistent, poorly explained, and overly strict eligibility situations for entering a cancer clinical trial exacerbate this problem and are a major reason for the low number of underrepresented minorities in trials.
“So many clinical trials never complete recruitment, close prematurely, or fail to recruit a population that allows researchers to generalize findings,” said Dr. Gerber. “I think it is widely recognized that the eligibility criteria have become too strict.”
To tackle this issue in a subset of cancer – advanced non-small cell lung cancer (NSCLC) – the LUNGevity Foundation hosted a panel discussion with experts from academia, industry and regulatory bodies. The team put together a prioritized list of eligibility categories that should be included in the descriptions of all NSCLC clinical trials and the recommended criteria for each category. Some suggestions were more lenient than what was typically included in the eligibility criteria of previous NSCLC trials eg the team recommended that most patients with prior or concurrent cancers, most patients with metastases and most patients with mild liver impairment – all of whom likely would have been excluded in the past – should still be included in the trials.
The team also suggested that these categories are clearly presented on public websites advertising clinical trials in an easily searchable structure.
The FDA will soon publish draft clinical trial guidelines on the NSCLC and will hold a public comment period before finalizing them. Other interdisciplinary teams have already come together to standardize eligibility issues for clinical trials in other types of most cancers.
If the new guidelines are effective, Dr. Gerber said clinical trials will likely be easier to complete and will provide more complete and timely data on new interventions for most cancers.
“If you can involve more more people in clinical trials, you are more likely to complete those trials quickly. This 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 the LUNGevity Foundation Patrick M. Forde of Johns Hopkins University and Wendy Selig of WSCollaborative LLC.
Dr. Gerber holds the David Bruton, Jr. Chair in Clinical Cancer Research.