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

Variability and Sample Size Requirements of Quality-of-Life Measures: A Randomized Study of Three Major Questionnaires

Predictive Value of Bone Resorption and Formation Markers in Cancer Patients With Bone Metastases Receiving the Bisphosphonate Zoledronic Acid To compare the variability and sample size requirements ...
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 ...
Morningstar

Trevi Therapeutics Announces Positive Outcome from Sample Size Re-estimation Resulting in No Change to the Current Sample Size for the Phase 2b CORAL Trial in Idiopathic ...

The trial has reached 75% of the targeted enrollment, and topline results continue to be expected in the first half of 2025 NEW HAVEN, Conn., Dec. 12, 2024 /PRNewswire/ -- Trevi Therapeutics, Inc.