Equitable Access to Clinical Trials: How Do We Achieve It?

Author:

Acuña-Villaorduña Ana1,Baranda Joaquina Celebre2,Boehmer Jessica3,Fashoyin-Aje Lola4,Gore Steven D.5

Affiliation:

1. Cancer Immunotherapy Program, Tisch Cancer Institute, Mount Sinai School of Medicine, New York, NY

2. Early Phase Research, Clinical Research Center, University of Kansas Cancer Center, Fairway, KS

3. Oncology Center of Excellence (OCE), US Food and Drug Administration, Silver Spring, MD

4. Office of Oncologic Diseases, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD

5. Early Therapeutics Clinical Trial Network, Investigational Drug Branch, Cancer Therapy Evaluation Program, National Cancer Institute, Shady Grove, MD

Abstract

The mismatch between the study populations participating in oncology clinical trials and the composition of the targeted cancer population requires urgent amelioration. Regulatory requirements can mandate that trial sponsors enroll diverse study populations and ensure that regulatory revue prioritizes equity and inclusivity. A variety of projects directed at increasing accrual of underserved populations to oncology clinical trials emphasize best practices: broadened eligibility requirements for trials, simplification of trial procedures, community outreach through patient navigators, decentralization of clinical trial procedures and institution of telehealth, and funding to offset costs of travel and lodging. Substantial improvement will require major changes in culture in the educational and professional practice, research, and regulatory communities and will require major increases in public, corporate, and philanthropic funding.

Publisher

American Society of Clinical Oncology (ASCO)

Subject

General Medicine

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