For results from cancer clinical trials to be more generalizable to the real world, there needs to be some loosening of exclusion criteria, say researchers.
A new study concludes that the National Cancer Institute (NCI) is making some headway in its efforts to do this, but the study also shows potential challenges.
“Exclusion of patients with comorbidities is a major barrier for clinical trial enrollment of the diverse populations typically seen in oncology practices,” say the authors. The results show that “modernized eligibility criteria can be successfully implemented, but that consistent implementation requires sustained focused effort.”
The study was published this month in the Journal of the National Cancer Institute.
In an accompanying editorial, Peter J. O’Dwyer, MD, notes that the efforts are important, although some of the changes may be more easier said than done.
“Clearly, implementation of approaches to expanding patient access and accruing broad representation in cancer clinical trials is a widely shared goal,” said O’Dwyer, of the Abramson Cancer Center, University of Pennsylvania, Philadelphia, Pennsylvania.
“Our concern is that methodologies to accomplish the goal should facilitate, not impede, the development of new and more effective treatments, and their broad availability to the public,” he said. “Our hope is that incorporation of novel trial designs into the arc of drug development will facilitate both of these needs.”
Adherence to the Recommended Criteria Varies
The study, conducted by Andrea M. Denicoff, RN, and researchers with the NCI’s Cancer Therapy Evaluation Program (CTEP), reviewed how commonly clinical trials included language in their criteria that the agency had recommended to improve generalizability of trial results across populations.
Recommendations regarded language used for seven major eligibility criteria involving cardiac status; liver and kidney function; HIV status; prior or concurrent malignancies; treated or stable brain metastasis; and new or progressive brain metastases.
The recommendations had been proposed by the American Society of Clinical Oncology (ASCO) in collaboration with Friends of Cancer Research with input from the US Food and Drug Administration (FDA).
Among 122 protocols that were evaluated in the analysis, 69 involved clinical trials in the National Clinical Trials Network, and 44 were for trials in the Experimental Therapeutics Network. All the trials were approved between 2018 and 2020.
Among these trials, 90 involved solid tumors and 32 involved hematologic cancers. Most of the protocols (84%) included an investigational new drug with industry collaborators.
Overall, the eligibility criteria implementation ranged from 54.1% for criteria relating to prior or concurrent malignances to 93.4% for criteria relating to HIV infection.
While about 87% of the protocols contained recommended language relating to their hepatic and renal criteria for the trials, 76.2% included language relating to patients living with HIV.