Dynamic clinical trial success rates for drugs in the 21st century.

ABSTRACT: In clinical drug development, two fundamental questions must be addressed: what is the success rate of drugs in clinical trial; how does such rate change over time. Here, a dynamic strategy for calculating clinical trial success rate (ClinSR) is proposed, which identifies that: the ClinSR has been declining since the early 21st century, yet it hits a plateau and recently starts to increase; the ClinSR for repurposed drugs is unexpectedly lower than that for all drugs in recent years; and an extremely low ClinSR is found for anti-COVID-19 drugs. In-depth analysis reports great variations among the ClinSRs of various diseases, developmental strategies, and drug modalities. A platform ClinSR.org ( https://ClinSR.org/ ), is then developed to show how ClinSRs change over time. All in all, this

SUBMITTER: Zhou Y 

PROVIDER: S-EPMC12572394 | biostudies-literature | 2025 Oct

REPOSITORIES: biostudies-literature