Other Useful Links
Below are useful links and resources:
BayesPOModel: This link provides the folder for STAN and JAGS files for simulating clinical trials for ordinal endpoints using a Bayesian progression model.
Antibiotic Platform Design: The ADAPT trial is an ARLG funded project to investigate the design of a Bayesian Adaptive platform trial for evaluating antibiotics in areas of unmet medical need.
MOST Trial Design Report: The Multi-arm Optimization of Stroke Thrombolysis (MOST) Stroke Trial is a five-arm, adaptive Phase III trial for demonstrating whether any of four treatments improve 90-day functional outcomes in stroke patients when given in addtion to intravenous rt-PA. This document describes the design and statistical models in detail and illustrates the design with an example simulated trial and simulated operating characteristics. The trial is being proposed to the NIH Stroke Trials Network (NIH StrokeNet).
International Society for Bayesian Analysis (ISBA)
Statistical Interest Group in Medical Devices & Diagnostics (SIGMEDD) of the American Statistical Association (ASA)
Massachusetts Institute of Technology’s (MIT) New Drug Development Paradigms (NEWDIGS) Program
Patient-Centered Outcomes Research Institute (PCORI) Methodology Reports and Selected Guidance Documents
PCORI’s Standards for the Design, Conduct, and Evaluation of Adaptive Randomized Clinical Trials Guidance Document provided by Berry Consultants
FDA’s Guidance for the Use of Bayesian Statistics in Medical Device Clinical Trials
FDA’s Draft Guidance for Adaptive Design Clinical Trials for Drugs and Biologics