ASCO and Friends of Cancer Research (Friends) are calling for the use of more inclusive eligibility criteria for cancer clinical trials in a new Special Series in the Journal of Clinical Oncology (JCO). The series provides a comprehensive examination of eligibility criteria for cancer clinical trials with recommendations to address eligibility criteria in five specific areas: minimum age requirements for trial enrollment; HIV/AIDS status; brain metastases, organ dysfunction; and prior and concurrent malignancies. These five areas were identified as most likely to restrict a patient’s participation in a trial but least likely to affect the safety of participants.
Working groups comprise researchers, patient advocates, regulators, and industry representatives generally found that concerns that have contributed to the historic exclusion of certain groups of patients are often not supported by data. In addition, since drugs are usually not tested in these specific patient populations until extensive preliminary study has been completed—or after the drug has been approved—arbitrarily excluding these patients limits their access to novel cancer agents and, thus, their ability to benefit from emerging advances in cancer treatment.
ASCO and Friends also worked closely with the U.S. Food and Drug Administration throughout the project to address this crucial issue. The organizations will continue to work with clinical trial sponsors and regulators to turn these recommendations into action and identify additional opportunities to safely expand eligibility criteria for oncology trials.
Access the series for the full recommendations and analyses online in JCO at ascopubs.org/JCO.