Strict Eligibility Criteria May Stymie Clinical Trials

Strict inclusion and exclusion criteria ensure randomized, controlled clinical trials produce valuable results with minimal risk to participants. However, nearly 20 percent of publicly-funded cancer clinical trials in the U.S. never produce results because investigators are unable to enroll enough patients. Overly strict entry criteria might be partly to blame, according to a report published in Nature.

Researchers and regulators have turned their attention to eliminating unnecessary rules that could be limiting patients’ access to investigational treatments. The U.S. Food and Drug Administration (FDA) will meet with stakeholders to discuss restrictive eligibility criteria later this month. An October 2017 joint report between the FDA, the American Society of Clinical Oncology, and Friends of Cancer Research identified common criteria for cancer-trial eligibility that could be changed, including:

  • People with HIV often live as long as those without the virus and should be included in many cancer trials.
  • Restrictions on people with organ dysfunction were put in place when cancer treatments were more broadly toxic and might not be necessary for the more targeted drugs available today.
  • Because adolescents metabolize drugs differently, the age of eligibility for adult cancer trials should be lowered from 18 to 12.

For more on the challenges of designing a clinical trial that is both internally and externally valid, read the October 2016 feature from ASH Clinical News.

Source: Nature, April 3, 2018.