@article{7646829c272d4748860031b1da515502,
title = "Modernizing clinical trial eligibility criteria: Recommendations of the ASCO⇓friends of cancer research prior therapies work group",
abstract = "Purpose: Restrictive eligibility criteria induce differences between clinical trial and “real-world” treatment populations. Restrictions based on prior therapies are common; minimizing them when appropriate may increase patient participation in clinical trials. Experimental Design: A multi-stakeholder working group developed a conceptual framework to guide evaluation of prevailing practices with respect to using prior treatment as selection criteria for clinical trials. The working group made recommendations to minimize restrictions based on prior therapies within the boundaries of scientific validity, patient centeredness, distributive justice, and beneficence. Recommendations: (i) Patients are eligible for clinical trials regardless of the number or type of prior therapies and without requiring a specific therapy prior to enrollment unless a scientific or clinically based rationale is provided as justification. (ii) Prior therapy (either limits on number and type of prior therapies or requirements for specific therapies before enrollment) could be used to determine eligibility in the following cases: a) the agents being studied target a specific mechanism or pathway that could potentially interact with a prior therapy; b) the study design requires that all patients begin protocol-specified treatment at the same point in the disease trajectory; and c) in randomized clinical studies, if the therapy in the control arm is not appropriate for the patient due to previous therapies received. (iii) Trial designers should consider conducting evaluation separately from the primary endpoint analysis for participants who have received prior therapies. Conclusions: Clinical trial sponsors and regulators should thoughtfully reexamine the use of prior therapy exposure as selection criteria to maximize clinical trial participation.",
author = "Osarogiagbon, {Raymond U.} and Vega, {Diana Merino} and Lola Fashoyin-Aje and Suparna Wedam and Gwynn Ison and Sol Atienza and {de Porre}, Peter and Tithi Biswas and Holloway, {Jamie N.} and Hong, {David S.} and Wempe, {Madison M.} and Schilsky, {Richard L.} and Kim, {Edward S.} and Wade, {James L.}",
note = "Funding Information: The working group acknowledges Drs. Wayne Rackoff (Janssen) and Lee Krug (Bristol Myers Squibb) for their insightful contribution to the initial development of the concepts discussed in this article. R.U. Osarogiagbon was supported by NIH 2UG1CA189873-06. Funding Information: R.U. Osarogiagbon reports grants from NIH; other from American Cancer Society, Eli Lilly, Gilead Sciences, and Pfizer; and personal fees from Association of Community Cancer Centers, Biodesix, AstraZeneca, and Triptych Healthcare Partners outside the submitted work, as well as a patent for US10,338,073B2 issued to R.U. Osarogiagbon, US10,422,801 issued to R.U. Osar-ogiagbon, and DE202012013719.0 issued to R.U. Osarogiagbon, and is founder of Oncobox Device Inc. D.M. Vega reports nonfinancial support from Aetion outside the submitted work. P. De Porre reports employment with Johnson & Johnson. J.N. Holloway reports employment with Caris Life Sciences. D.S. Hong reports research/ grant funding from AbbVie, Adaptimmune, Aldi-Norte, Amgen, Astra-Zeneca, Bayer, BMS, Daiichi Sankyo, Eisai, Erasca, Fate Therapeutics, Genentech, Genmab, Funding Information: Ignyta, Infinity, Kite, Kyowa, Lilly, Loxo, Merck, MedImmune, Mirati, miRNA, Molecular Templates, Mologen, Navier, NCI-CTEP, Novartis, Numab, Pfizer, Seattle Genetics, Takeda, Turning Point Therapeutics, Verstatem, and VM Oncology; travel, accommodations, expenses from Bayer, Loxo, miRNA, Genmab, AACR, ASCO, and SITC; consulting, speaker or advisory role to Alpha Insights, Acuta, Amgen, Axiom, Adaptimmune, Baxter, Bayer, Boxer Capital, COG, Ecor1, Genentech, GLG, Group H, Guidepoint, HCW Precision, Infinity, Janssen, Merrimack, Medscape, Numab, Pfizer, Prime Oncology, Seattle Genetics, ST Cube, Takeda, Tavistock, Trieza Therapeutics, and WebMD; and other ownership interests with Molecular Match (advisor), OncoResponse (founder), and Presagia Inc (advisor). R.L. Schilsky reports grants from AstraZeneca, Bayer, Boehringer Ingelheim, Bristol Myers Squibb, Genentech, Lilly, Merck, and Pfizer outside the submitted work. E.S. Kim reports personal fees from AstraZeneca, Boehringer Ingelheim, and Roche outside the submitted work. No disclosures were reported by the other authors. Publisher Copyright: 2021 American Association for Cancer Research.",
year = "2021",
month = may,
day = "1",
doi = "10.1158/1078-0432.CCR-20-3854",
language = "English (US)",
volume = "27",
pages = "2408--2415",
journal = "Clinical Cancer Research",
issn = "1078-0432",
publisher = "American Association for Cancer Research Inc.",
number = "9",
}