Viewpoint: Unnecessary clinical trial exclusions deny patients life-saving treatment

Unnecessarily excluding patients from clinical trials due to strict eligibility requirements forces a number of sick patients to be denied opportunities to test life-saving treatments, argues David Gerber, MD, in a STAT op-ed.

Dr. Gerber, associate director for clinical research at the Harold C. Simmons Comprehensive Cancer Center at UT Southwestern Medical Center in Dallas, noted the FDA's upcoming public meeting, which will address issues related to clinical trial eligibility criteria. The meeting will allow researchers, study sponsors, patients and the general public to share their experiences and urge regulators to revisit the criteria.

"Despite repeated calls in recent years to simplify clinical trial criteria, they continue to grow more complex," Dr. Gerber wrote. "In a study my colleagues and I published last year, we found that over the past 30 years, the average number of eligibility criteria in lung cancer trials sponsored by the National Cancer Institute grew by 50 percent to an average of more than 25."

As cancer treatments continue to become more targeted, the clinical trial's investigators and sponsors, often academic researchers or pharmaceutical companies, have to refine the protocol for selecting participants, Dr. Gerber noted.

"Still, every exclusion criterion must be evaluated critically and justified as being directly relevant to preserving patient safety or producing a quality scientific outcome," he added.

Dr. Gerber's study found a number of clinical trials added restrictions related to the risks of new treatments. However, these trials frequently neglected to remove restrictions that were no longer relevant.

These growing exclusions are decreasing the number candidates who can participate in trials and resulting in drug development delays, Dr. Gerber noted. Currently, Dr. Gerber said, fewer than 2 percent of adult cancer patients in the U.S. are treated in clinical trials.

"If clinical trials enroll only a highly select minority of patients, we may not be able to generalize their results to a broader population of individuals who have the disease," Dr. Gerber wrote. "Allowing more patients to be enrolled in trials will speed the medical innovation process, allow more sick people to access potentially beneficial therapies, and produce more generalized results."

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