On August 8, ASCO and Friends of Cancer Research (Friends) submitted recommended language to the U.S. Food and Drug Administration (FDA) for five guidance documents on ways to broaden eligibility criteria for cancer clinical trials. The recommendations are part of an ASCO and Friends collaboration to broaden eligibility for participating in clinical trials by addressing five specific areas: minimum age requirements for trial enrollment; HIV/AIDS status; brain metastases; organ dysfunction; and prior and concurrent malignancies.
Eligibility criteria lay out the characteristics that potential clinical trial participants must meet to participate and often include age; current health status; gender; medical history; and particular type of cancer and its stage. By defining the characteristics of the study population in this way, researchers can better understand the efficacy and toxicity of the study treatment and minimize the impact of confounding factors on interpretation of the study results. However, with more stringent eligibility criteria, fewer patients qualify to participate, making the results less applicable to treat the more diverse patient populations seen in routine clinical practice.
ASCO and Friends launched a collaborative effort in early 2016 to modernize eligibility criteria to promote greater patient participation in cancer clinical trials. The five areas were identified where eligibility criteria were most likely to restrict a patient’s participation in a trial but least likely to affect the safety of participants. Working groups of researchers, patient advocates, regulators, and industry representatives examined each of the areas and made recommendations on modifying the specific inclusion and exclusion criteria that often restrict participation of patients. ASCO and Friends also worked closely with the FDA throughout the project.
In October 2017, the two organizations published a joint research statement providing a comprehensive examination of eligibility criteria for cancer clinical trials with recommendations to address eligibility criteria in these five specific areas. To help implement these recommendations, ASCO and Friends next drafted the August 8 guidance documents with rationale and instructions for expanding eligibility criteria.
The FDA plans to review the ASCO/Friends recommended language as the agency finalizes draft guidance documents to release for public comment. ASCO and Friends will announce when the draft guidance documents are available for comment and develop comments for submission.