American Association for Cancer Research
10780432ccr203853-sup-252829_2_supp_6785650_qlc9py.docx (20.96 kB)

Supplementary Table S1 from Modernizing Clinical Trial Eligibility Criteria: Recommendations of the ASCO-Friends of Cancer Research Laboratory Reference Ranges and Testing Intervals Work Group

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journal contribution
posted on 2023-03-31, 23:16 authored by Alexander I. Spira, Mark D. Stewart, Suzanne Jones, Elaine Chang, Anitra Fielding, Nicole Richie, Laura S. Wood, Michael A. Thompson, Lee Jones, Abhilasha Nair, Brandon A. Mahal, David E. Gerber

Published manuscripts supporting 23 of the 26 approvals were retrieved (as of March 2020) and the eligibility criteria specifics for each trial were extracted from each manuscript.





In clinical research, eligibility criteria promote patient safety and optimize the evidence generated from clinical trials. However, overly stringent eligibility criteria, including laboratory requirements, may limit enrollment, resulting in delayed trial completion and potentially limiting applicability of trial results to a general practice population. Starting in 2018, a working group consisting of experts in direct patient care, the FDA, industry, and patient advocacy developed recommendations to guide the optimal use of laboratory reference ranges and testing intervals in clinical trial eligibility criteria and study procedures. The working group evaluated current eligibility criteria across different clinical trial phases and performed a literature review to evaluate the impact of and justification for laboratory test eligibility requirements and testing intervals in clinical trials. Recommendations were developed on the basis of the goals of promoting safety and optimizing the evidence generated, while also expanding eligibility and applicability, and minimizing excess burden of trial participation. In general, we found little variation over time and trial phase in laboratory test requirements, suggesting that these eligibility criteria are not refined according to ongoing clinical experience. We propose recommendations to optimize the use of laboratory tests when considering eligibility criteria. Tailoring the use of laboratory test requirements and testing intervals may increase the number and diversity of patients in clinical trials and provide clinical data that more closely represent the general practice populations.See related commentary by Giantonio, p. 2369

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