Decision-Making Criteria and Methods for Initiating Late-Stage Clinical Trials in Drug Development From a Multi-Stakeholder Perspective: A Scoping Review.

ABSTRACT: The decision-making process in drug development involves "go/no-go" decisions, particularly at the transition from early to late-stage trials. While the decisions are solely made by drug developers, they must take into account the perspectives of multiple stakeholders-such as regulatory agencies, HTA bodies, payers, patients, and ethics committees-to ensure well-informed and robust decision-making. These perspectives influence key considerations, including resource allocation, risk mitigation, regulatory compliance, etc. To support this process, quantitative methodologies, including Bayesian and hybrid frequentist-Bayesian approaches, have been introduced to improve decision-making. However, these methodologies often do not fully account for the diverse priorities and needs of all stakehol

SUBMITTER: Jiang C 

PROVIDER: S-EPMC11924168 | biostudies-literature | 2025 Apr

REPOSITORIES: biostudies-literature