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

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.

The usage of population and disease registries as pre-screening tools for clinical trials, a systematic review

“…A typical pre-screening process may include an internal check of the hospital medical journals in paper format, a review of electronic medical journals, a review of medical journals sent via traditional mail in case of a referral, direct emails from patients emailing a research team, and more [ 27 – 30 ]. This creates a pool of information derived from several sources, with no standardized system assuring quality and replicability, not allowing an audit trail for quality assurance and control, and overall creating inequitable trial access for patients [ 31 ]. Clinical trial eligibility criteria will often include both demographic data and disease specific information.…”