Hope is Not a Strategy: Using Robust Real-World Evidence to Make Better Clinical Development Decisions.

ABSTRACT: Clinical development delays and failures do not serve public health. Reliance solely on expert opinion or historical patterns rather than evidence from representative, real-world point-of-care data about the indication results in suboptimal trial design, missed opportunities, and uninterpretable findings. Investment in real-world evidence (RWE) generation to build a deep, comprehensive, and current understanding of the characteristics, care, and outcomes of the indicated population is essential to improving clinical development decision making. Despite the recognized value of RWE, this evidence generation is not done systematically. Here we make integrated RWE generation more compelling and practicable by addressing concerns we have heard from biopharma leaders and, for emerging RWE leader

SUBMITTER: Gatto NM 

PROVIDER: S-EPMC12579674 | biostudies-literature | 2025 Nov

REPOSITORIES: biostudies-literature