On the Concepts, Methods, and Use of "Probability of Success" for Drug Development Decision-Making: A Scoping Review.

ABSTRACT: Drug development is a lengthy process with considerable uncertainty at each milestone. Several trials are needed to progress to confirmatory evaluation and establish a positive benefit-risk balance. One of the critical milestones is the decision to progress to phase III based on phase II trial results. Use of probability of success is becoming standard in pharmaceutical companies to support this decision. However, the lack of consistency in terminology makes it difficult to assess the comparative value of different approaches. By leveraging the availability of high-quality external data (e.g., real-world data, historical clinical trial data, etc.), probability of success-based procedures may further improve decision-making. We performed a scoping review of approaches to calculate the proba

SUBMITTER: Cetinyurek Yavuz A 

PROVIDER: S-EPMC11924160 | biostudies-literature | 2025 Apr

REPOSITORIES: biostudies-literature