To make clinical trials equitable, cancer groups evaluate restrictive eligibility criteria

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Emergent public-private partnerships (PPPs) have risen to the occasion to streamline and coordinate severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccines. With these monumental efforts have come important public discussions about equitable access and representation in clinical trials (CTs).  

Equitable access to CTs—that is, the opportunity for all patients to access CTs that may offer improved outcomes and the evidence-based standard of care treatment that CTs offer—must be a priority.Improved access in CTs will benefit individual patients, and improving inclusiveness of trial populations will benefit all patients with a given disease. Clinicians will also have greater confidence in the generalizability of CT data to make informed treatment decisions. 

Eligibility criteria (EC), the inclusion and exclusion criteria written into trial protocols by the study sponsor, are intended to ensure patient safety. Overly restrictive EC, however, are a significant impediment to enrollment and equity, because they consistently exclude certain groups, particularly older adults, racial/ethnic minorities, and patients with previous/ongoing chronic medical conditions. 

While narrow EC are not intended to discriminate against any individual or group, that is the effect, and it is unacceptable. 

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Julia Beaver, MD
Chief of medical oncology, Oncology Center of Excellence, Deputy director (acting), Office of Oncologic Diseases, FDA Center for Drug Evaluation and Research
Thomas S. Uldrick, MD
Affiliate Professor, Fred Hutchinson Cancer Research Center
Gwynn Ison, MD
Medical officer/ clinical reviewer,
FDA Office of Oncologic Diseases
Suanna S. Bruinooge, MPH
Director, Research Strategy & Operations Div., Center for Research and Analytics, American Society of Clinical Oncology
Caroline Schenkel, MSc
Manager, Research Analysis and Publications, American Society of Clinical Oncology
Edward S. Kim, MD, MBA, FACP, FASCO
Physician-in-Chief, Orange County; Vice Physician-in-Chief, City of Hope National Medical Center
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Julia Beaver, MD
Chief of medical oncology, Oncology Center of Excellence, Deputy director (acting), Office of Oncologic Diseases, FDA Center for Drug Evaluation and Research
Thomas S. Uldrick, MD
Affiliate Professor, Fred Hutchinson Cancer Research Center
Gwynn Ison, MD
Medical officer/ clinical reviewer,
FDA Office of Oncologic Diseases
Suanna S. Bruinooge, MPH
Director, Research Strategy & Operations Div., Center for Research and Analytics, American Society of Clinical Oncology
Caroline Schenkel, MSc
Manager, Research Analysis and Publications, American Society of Clinical Oncology
Edward S. Kim, MD, MBA, FACP, FASCO
Physician-in-Chief, Orange County; Vice Physician-in-Chief, City of Hope National Medical Center

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