The roadmap to integrate diversity, equity, and inclusion in hematology clinical trials: an American Society of Hematology initiative

ABSTRACT: Clinical trial design for classical hematologic diseases is difficult because samples sizes are often small and not representative of the disease population. The American Society of Hematology initiated a roadmap project to identify barriers and make progress to integrate diversity, equity, and inclusion into trial design and conduct. Focus groups of international experts from across the clinical trial ecosystem were conducted. Eight issues identified include (1) harmonization of demographic terminology; (2) engagement of lived experience experts across the entire study timeline; (3) awareness of how implicit biases impede patient enrollment; (4) the need for institutional review boards to uphold the justice principle of clinical trial enrollment; (5) broadening of eligibility criteria; (6) decentralized trial design; (7) improving access to clinical trial information; and (8) increased community physician involvement. By addressing these issues, the hematology community can promote accessible and inclusive trials that will further inform research, clinical decision-making, and care for patients.