A clinical trial is just as powerful as its participants. For years, researchers have struggled to fill clinical trials and enroll sufficiently diverse groups of patients for results to reflect the broader population, partly due to stringent guidelines on who can participate.
In an effort to incorporate a bigger and more diverse population, a world team of researchers and policymakers has written recent recommendations on learn how to determine eligibility criteria for lung cancer clinical trials. The group was led partly by David Gerber, M.D., Associate Director for Clinical Research at UT Southwestern’s Harold C. Simmons Comprehensive Cancer Center, together with representatives from the Food and Drug Administration (FDA), National Cancer Institute, European Medicines Agency, pharmaceutical firms, and the LUNGevity Foundation.
The recommendations, published today in JAMA Oncology, offer the primary publicly available outline of upcoming FDA draft guidance on lung cancer clinical trials which might be expected to make it easier to incorporate more patients.
This paper is the general public’s first take a look at the FDA’s proposed changes to how we determine who can take part in a lung cancer clinical trial. If these changes are successful, they might make clinical trials for lung cancer in addition to other cancers more powerful and more representative.”
Dr. David Gerber, Professor of Internal Medicine within the Hematology/Oncology Division at UTSW
Ensuring that folks from diverse backgrounds join clinical trials is vital to properly evaluating how a recent treatment will work amongst 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 discover as a racial or ethnic minority.
For patients with cancer, participation in clinical trials requires not only a choice to try an experimental treatment, but time and energy spent understanding the trial, enrolling in it, and infrequently attending extra testing or clinic appointments. Many researchers agree that complicated, inconsistent, poorly explained, and overly strict eligibility requirements to affix a cancer clinical trial exacerbate this problem and are a key reason for the low variety of underrepresented minorities in clinical trials.
“So many clinical trials never finish enrollment, close prematurely, or don’t recruit a population that lets researchers generalize the outcomes,” Dr. Gerber said. “I believe there’s widespread recognition that eligibility criteria have develop into too stringent.”
To tackle this problem in a single cancer subtype – advanced non-small cell lung cancer (NSCLC) – the LUNGevity Foundation convened a roundtable discussion with experts from academia, industry, and regulatory bodies. The team assembled a prioritized list of eligibility categories that ought to be included within the descriptions of all NSCLC clinical trials and advisable criteria for every category. Some suggestions were more lenient than what has typically been included in previous NSCLC trial eligibility criteria; as an example, the team advisable that the majority patients with prior or concurrent cancers, most patients with brain metastases, and most patients with mild liver impairment – all of whom would likely have been excluded up to now – still be included in trials.
The team also suggested that these categories be clearly laid out on public web sites promoting clinical trials in an easily searchable format.
The FDA shall be releasing draft guidance on NSCLC clinical trials within the near future and hold a public comment period before finalizing them. Other interdisciplinary teams have already convened to standardize eligibility requirements for clinical trials of other cancer types.
If the brand new guidelines are effective, Dr. Gerber said clinical trials will likely be easier to fill and supply more complete and timely data on recent cancer interventions.
“When you can involve more patients in clinical trials, you are more likely to finish those trials quickly. That is going to guide to recent 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.
Source:
UT Southwestern Medical Center