TY - JOUR
T1 - Modernizing eligibility criteria for molecularly driven trials
AU - Kim, Edward S.
AU - Bernstein, David
AU - Hilsenbeck, Susan G.
AU - Chung, Christine H.
AU - Dicker, Adam P.
AU - Ersek, Jennifer L.
AU - Stein, Steven
AU - Khuri, Fadlo R.
AU - Burgess, Earle
AU - Hunt, Kelly
AU - Ivy, Percy
AU - Bruinooge, Suanna S.
AU - Meropol, Neal
AU - Schilsky, Richard L.
N1 - Publisher Copyright:
© 2015 by American Society of Clinical Oncology.
PY - 2015/9/1
Y1 - 2015/9/1
N2 - 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.
AB - 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.
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U2 - 10.1200/JCO.2015.62.1854
DO - 10.1200/JCO.2015.62.1854
M3 - Article
C2 - 26195710
AN - SCOPUS:84941370336
SN - 0732-183X
VL - 33
SP - 2815
EP - 2820
JO - Journal of Clinical Oncology
JF - Journal of Clinical Oncology
IS - 25
ER -