Background
The era of precision oncology increases the potential for limitations in clinical trial participation due to molecular profiling of participants’ tumors. Narrow eligibility criteria can exclude too many people, leading to study results that may not inform treatment options for the diverse groups of people with a particular cancer. Therefore, it is important for investigators to carefully consider whether each eligibility criterion in a clinical trial is too narrow and would unnecessarily exclude people.
Eligibility criteria must be as broad as safely possible to achieve diverse and representative populations in future clinical trials.
A 2017 joint statement from the American Society of Clinical Oncology (ASCO) and Friends of Cancer Research (Friends) outlined recommendations from four working groups to expand and modernize clinical trial eligibility. These working groups provided recommendations and protocol template language to expand eligibility for the following criteria:
- Brain metastases
- Age < 18
- HIV infection
- Prior and concurrent malignancies and organ dysfunction, including cardiac, liver, and kidney function
Implementation of the Expanded Eligibility Recommendations
DCTD’s Cancer Therapy Evaluation Program (CTEP) has played a major role towards implementing the ASCO and Friends recommendations. CTEP’s efforts included:
- Providing updated template language to principal investigators for implementing the proposed expanded criteria into their clinical trial protocols. However, in late 2018 and early 2019, most CTEP-approved protocols had not adopted the ASCO/Friends recommendations.
- Forming a CTEP pilot implementation team to review and require that study teams provide scientific justification for departure from the recommendations. The pilot led to 80-90% of trials implementing more inclusive eligibility. (1)
- Incorporating the additional 2021 ASCO and Friends recommendations in protocol templates to further expand eligibility criteria in the areas of performance status, prior therapies allowed, concomitant medications, washout periods, and testing intervals. (2)
Conclusions
Reducing restrictive eligibility criteria makes it possible to enroll more participants to trials and finish enrollment faster. This helps ensure that trial are more streamlined and efficient. CTEP continues to monitor eligibility criteria and work to ensure the least restrictive criteria are used in NCI-supported clinical trials.