Modernizing Eligibility Criteria for Molecularly Driven Trials.

Authors

• Edward S Kim
• David Bernstein
• Susan G Hilsenbeck
• Christine H Chung
• Adam P Dicker
• Jennifer L Ersek
• Steven Stein
• Fadlo R Khuri
• Earle Burgess
• Kelly Hunt
• Percy Ivy
• Suanna S Bruinooge
• Neal Meropol
• Richard L Schilsky

Publication/Presentation Date

9-1-2015

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.

Volume

33

Issue

25

First Page

2815

Last Page

2820

ISSN

1527-7755

Published In/Presented At

Kim, E. S., Bernstein, D., Hilsenbeck, S. G., Chung, C. H., Dicker, A. P., Ersek, J. L., Stein, S., Khuri, F. R., Burgess, E., Hunt, K., Ivy, P., Bruinooge, S. S., Meropol, N., & Schilsky, R. L. (2015). Modernizing Eligibility Criteria for Molecularly Driven Trials. Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 33(25), 2815–2820. https://doi.org/10.1200/JCO.2015.62.1854

Disciplines

Business Administration, Management, and Operations | Health and Medical Administration | Management Sciences and Quantitative Methods

PubMedID

26195710

Department(s)

Administration and Leadership

Document Type

Article