Posted by Michael Wonder on 22 Nov 2017
Broadening eligibility criteria to make clinical trials more representative: American Society of Clinical Oncology and Friends of Cancer Research Joint Research Statement
22 November 2017 - Excessive or overly restrictive eligibility criteria can slow trial accrual, jeopardise the generalisability of results, and limit understanding of the intervention’s benefit-risk profile.
ASCO, Friends of Cancer Research, and the US FDA examined specific eligibility criteria (ie, brain metastases, minimum age, HIV infection, and organ dysfunction and prior and concurrent malignancies) to determine whether to modify definitions to extend trials to a broader population. Working groups developed consensus recommendations based on review of evidence, consideration of the patient population, and consultation with the research community.
To maximise the generalisability of results, trial enrolment criteria should strive for inclusiveness. Rationale for excluding patients should be clearly articulated and reflect expected toxicities associated with the therapy under investigation.
