Researchers Call for Revised Clinical Trial Criteria

Nearly 20 percent of publicly funded U.S. cancer clinical trials cannot enroll enough participants for the study to continue, and researchers are looking to revise eligibility criteria as a potential solution.

Representatives from the U.S. Food and Drug Administration (FDA) met with stakeholders in Washington, DC, on April 16 to discuss how restrictive eligibility criteria for clinical trials could be limiting patient access to experimental treatments, and the agency plans to use this discussion to develop guidelines for drug makers.

Some researchers say using templated protocols leads to a “copy-and-paste” approach to inclusion and exclusion criteria in clinical trials, which could needlessly restrict participation.

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 amended, without harming participants or the integrity of the trial. Their recommendations included:

  • People with HIV should be eligible for many cancer trials because these patients often live as long as those without the virus.

  • 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 similarly to adults, 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 December 2016 feature from ASH Clinical News.

Sources: Ledford H. Cancer researchers push to relax rules for clinical trials. Nature. 2018;556:12-3; Nature News, April 3, 2018.