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?
News Medical

Streamlining RSV clinical trial sample workflows

The analysis of samples containing Respiratory Syncytial Virus (RSV) in clinical trials is notoriously challenging due to the virus's inherent instability. hVIVO’s proprietary Stabilization Transport ...
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 ...
Business Wire

Amylyx Pharmaceuticals Donates CENTAUR Clinical Trial Data and Participant Samples to Help Advance Science in ALS for Future Treatments and Discoveries

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Amylyx Pharmaceuticals, Inc. today announced the donation of data from the CENTAUR clinical trial that evaluated the safety and efficacy of AMX0035 in participants ...
Nature

Smaller sample sizes for phase II trials based on exact tests with actual error rates by trading-off their nominal levels of significance and power

Sample sizes for single-stage phase II clinical trials in the literature are often based on exact (binomial) tests with levels of significance (alpha (α) <5% and power >80%). This is because there is ...
ascopubs.org

JCO Precision Oncology Conversations

JCO Precision Oncology Conversations features discussions with leading authors of JCO Precision Oncology articles, hosted by Dr. Abdul Rafeh Naqash. Join our experts in engaging conversations as they ...