American Society of Clinical Oncology (ASCO) and Friends of Research ran a task force evaluating the impact of cancer trial clinical trial eligibility criteria on oncology-based study enrollment. They found that if a clinical trial protocol included less than 27 eligibility criteria than the clinical trial sponsor had a higher likelihood of enrollment. It would appear that at least some eligibility criteria may not actually have to be included—hence making it easier to enroll patients in a study. Listen to the Onclive interview of Edward S. Kim, MD, chair, Department of Solid Tumor Oncology, Levine Cancer Institute, Atrium Health.
Rapid Growth of Investigational Oncology Treatment Requires Great Number of Trials
The task force outcome findings were recently reported in the Journal of Clinical Oncology, October 2017. We have seen rapid growth in new and promising cancer treatments. Consequently, as the number of clinical trials increases to test them, so does the need for patients. With overly ridged eligibility criteria it would be impossible to conduct all of the existing and new trials upcoming.
Overly Rigid Inclusion/Exclusion Criteria Impedes Progress
Hence there is a growing movement within oncology research to maximize the number of patients who are eligible for clinical trials but without compromising patient safety. It is imperative within the oncology research paradigm to understand the risk and benefit calculus of patients as well.
The ASCO-led task force offered examples such as age and HIV. They studied whether a minimum age of 18 and HIV negativity should serve as exclusion criteria—and concluded that they shouldn’t. For that matter, the task force found that perhaps in some cases exclusion criteria make its way into oncology trials because they are “copied and pasted over from the previous protocol” and this helps no one. Moving forward sponsors should offer clinical rationale why particular criteria should be categorized as “exclusion” for a particular study. The net result will be that more patients will actually be eligible—and may actually benefit from advanced investigational cancer medicines.
Edward S. Kim, MD, Chair, Department of Solid Tumor Oncology, Levine Cancer Institute, Atrium Health
Call to Action: For sponsors that are involved with the rationalization and optimization of their clinical trial programs—especially in oncology—watch this Onclive video and read the report.