Reducing clinical trial eligibility barriers for patients with MDS: an icMDS position statement.

ABSTRACT:

Abstract

Excessively restrictive inclusion and exclusion criteria in clinical trials are one of many barriers to clinical trial enrollment for patients with myelodysplastic syndromes/neoplasms (MDSs). Many organizations are developing efforts to increase clinical trial eligibility; yet, several recent publications focused on patients with MDS suggest that many patients with this disease may be excluded from clinical trials unnecessarily. Clinical trial eligibility should reflect the phase of the study and risks of the agent being studied. Phase 3 trials should be less restrictive than early-phase trials to represent the real-world population as closely as possible. We hypothesize that many clinical trials, particularly phase 3 trials, have unnecessarily restrictive eligibility crit

SUBMITTER: Borate U 

PROVIDER: S-EPMC11969261 | biostudies-literature | 2025 Mar

REPOSITORIES: biostudies-literature