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How Will Expanded Eligibility Criteria Impact Clinical Trial Design?

How Will Expanded Eligibility Criteria Impact Clinical Trial Design?

Creating a New Cancer Research Paradigm by Broadening Eligibility Criteria

The American Society of Clinical Oncology (ASCO, a professional society for cancer clinicians and researchers) and Friends of Cancer Research (Friends, a cancer advocacy organization focused on advancing science, policy, and regulation) have been collaborating to promote broader, more inclusive cancer clinical trial eligibility criteria since 2016. On April 9, 2021, ASCO and Friends co-hosted a virtual event on the topic. Stakeholders from research sites, government, patient advocacy, and industry convened to discuss the real-world benefits and challenges to implementing a new cancer research paradigm where patients are eligible for clinical trials as the default, and only excluded when there is justifiable concern for patient safety. 

This is the second in a series of articles in which event and project participants will address audience questions submitted during the April 9 event (some questions have been edited for clarity or length). Questions were answered by Michael A. Thompson, MD, PhD, FASCO, a hematologist/oncologist and cancer researcher at Advocate Aurora Health. He is Medical Director of the Early Phase Cancer Research Program, co-PI of the Aurora NCI Community Oncology Research Program (NCORP) and is co-Director of the Oncology Precision Medicine program. He is a member of the Broadening Eligibility Criteria Phase Task Force and serves on the ASCO Board of Directors.

The first blog featured responses from Julia A. Beaver, MD. For more information about the ASCO-Friends collaboration and recommendations for broadened eligibility criteria, please visit the ASCO and Friends websites.

How does a clinical practitioner find time and energy to build clinical trials into their practice, especially when there are too many laws, regulations, and complexities associated with trials? 
MT: You get what you incentivize. Unfortunately, much of medicine has disincentives for engaging in clinical research. ASCO has been at the forefront for examining ways to improve clinical trial access, feasibility assessment, eligibility, research contracting, and other aspects. For the average oncologist it can be difficult and depends on the level of societal and institutional support provided. That said, National Cancer Institute (NCI) clinical trials are classically underfunded but don’t have contracting issues and have the NCI central Institutional Review Boards (IRB). NCORP helps with networking with the National Clinical Trials Network (NCTN) and between sites. Pharma sponsored clinical trials offer novel therapeutics and higher funding levels, but increased complexity, effort, and often proprietary, inefficient monitoring platforms and contract research organizations (CROs). Investigator initiated clinical trials are excellent for new idea testing, but require time to develop and implement, which may be limited at many sites. 
Does the sample size have to increase to accommodate the broadened eligibility criteria? Should these separate arms for those with comorbidities need to start from early phase trials to guide dose finding in such patients to then guide phase 3 trials?  
MT: It depends. Phase 1 trials vs Phase 3 trials have different primary endpoints and drug development goals. If the inclusion/exclusion criteria closely resemble the population treated, that goes a long way towards generalizability. Including comorbidities that reflect the population and do not (or do) directly affect the study drug pharmacokinetics or pharmacodynamics should be studied. Also, more complementary studies of real-world data (RWD) / real-world evidence (RWE) will be used to supplement the findings of clinical trials. 


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