JD Supra

Unpacking Averages: Sample Size for Clinical Trials Used to Obtain FDA Medical Device Clearance

Our latest focus is trying to bring data to bear on common questions we get asked by clients. Last month the topic was: how well does my device need to perform to get premarket clearance from FDA?
ascopubs.org

Bayesian Sample Size Planning Tool for Phase I Dose-Finding Trials

Implementation of the Time-to-Event Continuous Reassessment Method Design in a Phase I Platform Trial Testing Novel Radiotherapy-Drug Combinations—CONCORDE BayeSize applies the concept of effect size ...
TCTMD

Micell Technologies Announces Reduced Clinical Trial Sample Size for MiStent® Drug-Eluting Coronary Stent Based on Early Clinical Data

DURHAM, N.C., Micell Technologies, Inc. today announced that it has completed its review of the scheduled four-month follow-up on the first 10 patients from the DESSOLVE I first-in-human trial of the ...
Nasdaq

Trevi Therapeutics Announces Positive Outcome of the Sample Size Re-Estimation Analysis in PRISM Trial for Severe Pruritus in Patients With Prurigo Nodularis

NEW HAVEN, Conn., July 13, 2020 (GLOBE NEWSWIRE) -- Trevi Therapeutics, Inc. (Nasdaq: TRVI), a clinical-stage biopharmaceutical company focused on the development and commercialization of Haduvio ...