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Modernizing Eligibility Criteria for Molecularly Driven Trials.
Edward S Kim1, David Bernstein2, Susan G Hilsenbeck2
1Edward S. Kim, Jennifer L. Ersek, and Earle Burgess, Levine Cancer Institute, Carolinas HealthCare System, Charlotte, NC; David Bernstein, Suanna S. Bruinooge, and Richard L. Schilsky, American Society of Clinical Oncology, Alexandria, VA; Susan G. Hilsenbeck, Dan L. Duncan Cancer Center, Baylor College of Medicine; Kelly Hunt, University of Texas MD Anderson Cancer Center, Houston, TX; Christine H. Chung, Johns Hopkins University School of Medicine, Baltimore; Percy Ivy, National Cancer Institute, Bethesda, MD; Adam P. Dicker, Sidney Kimmel Medical College and Cancer Center at Thomas Jefferson University, Philadelphia, PA; Steven Stein, Novartis, East Hanover, NJ; Fadlo R. Khuri, Winship Cancer Institute, Emory University, Atlanta, GA; and Neal Meropol, University Hospitals Case Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center, Case Western Reserve University, Cleveland, OH. edward.kim@carolinashealthcare.org.
Excessive clinical trial eligibility criteria can limit patient populations and drug applicability. A proposed algorithmic approach aims to streamline criteria for molecularly targeted therapies.
Area of Science:
- Oncology
- Clinical Trial Design
- Pharmacogenomics
Background:
- Increasingly complex eligibility criteria in molecularly targeted agent clinical trials.
- Potential disconnect between trial populations and real-world patient demographics.
Purpose of the Study:
- To evaluate the impact of eligibility criteria on clinical trial populations.
- To propose methods for streamlining criteria in molecularly driven therapy trials.
Main Methods:
- Evaluation by the American Society of Clinical Oncology Cancer Research Committee.
- Analysis of physician agreement on the effects of excessive criteria.
Main Results:
- Mixed evaluation results regarding the utility and impact of eligibility criteria.
- Physician consensus that stringent criteria impede enrollment, though data validation was challenging.
Conclusions:
- Excessive eligibility criteria may hinder trial enrollment and limit generalizability.
- Proposal for a public workshop to develop an algorithmic approach for optimizing trial eligibility criteria.
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