title: Modernizing Eligibility Criteria for Molecularly Driven Trials.
abstract: As more clinical trials of molecularly targeted agents evolve, the number of eligibility criteria seems to be increasing. The importance and utility of eligibility criteria must be considered in the context of the fundamental goal of a clinical trial: to understand the risks and benefits of a treatment in the intended-use patient population. Although eligibility criteria are necessary to define the population under study and conduct trials safely, excessive requirements may severely restrict the population available for study, and often, this population is not reflective of the general population for which the drug would be prescribed. The American Society of Clinical Oncology Cancer Research Committee, which comprises academic faculty, industry representatives, and patient advocates, evaluated this issue. Evaluation results were mixed. Most physicians agreed that excessive eligibility criterias slow study enrollment rates and prolong the duration of enrollment; however, this hypothesis was difficult to validate with the data examined. We propose the organization of a public workshop, with input from regulatory bodies and key stakeholders, with the goal of developing an algorithmic approach to determining eligibility criteria for individual study protocols, which may help guide future investigators and companies in streamlining eligibility criteria in the era of molecularly driven therapy.
authors.affiliation: Edward 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.
authors.forename: Edward S
authors.initials: ES
authors.lastname: Kim
authors.affiliation: Edward 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.
authors.forename: David
authors.initials: D
authors.lastname: Bernstein
authors.affiliation: Edward 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.
authors.forename: Susan G
authors.initials: SG
authors.lastname: Hilsenbeck
authors.affiliation: Edward 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.
authors.forename: Christine H
authors.initials: CH
authors.lastname: Chung
authors.affiliation: Edward 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.
authors.forename: Adam P
authors.initials: AP
authors.lastname: Dicker
authors.affiliation: Edward 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.
authors.forename: Jennifer L
authors.initials: JL
authors.lastname: Ersek
authors.affiliation: Edward 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.
authors.forename: Steven
authors.initials: S
authors.lastname: Stein
authors.affiliation: Edward 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.
authors.forename: Fadlo R
authors.initials: FR
authors.lastname: Khuri
authors.affiliation: Edward 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.
authors.forename: Earle
authors.initials: E
authors.lastname: Burgess
authors.affiliation: Edward 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.
authors.forename: Kelly
authors.initials: K
authors.lastname: Hunt
authors.affiliation: Edward 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.
authors.forename: Percy
authors.initials: P
authors.lastname: Ivy
authors.affiliation: Edward 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.
authors.forename: Suanna S
authors.initials: SS
authors.lastname: Bruinooge
authors.affiliation: Edward 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.
authors.forename: Neal
authors.initials: N
authors.lastname: Meropol
authors.affiliation: Edward 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.
authors.forename: Richard L
authors.initials: RL
authors.lastname: Schilsky
mesh_terms: D000465:Algorithms; D000970:Antineoplastic Agents / Q000494:pharmacology*; D014408:Biomarkers, Tumor / Q000235:genetics / Q000378:metabolism; D002986:Clinical Trials as Topic / Q000379:methods / Q000592:standards / Q000639:trends; D006801:Humans; D008495:Medical Oncology / Q000639:trends*; D058990:Molecular Targeted Therapy; D009369:Neoplasms / Q000188:drug therapy* / Q000235:genetics / Q000378:metabolism; D018579:Patient Selection; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; D014408:Biomarkers, Tumor