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 ...
Business Wire

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

- Amylyx Adds Data from CENTAUR to the Anonymized PRO-ACT Database, the Largest ALS Clinical Trial Dataset Ever Created - Company Also Donates Patient Samples from CENTAUR to theNortheast ALS ...
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 ...