Other Useful Links

Below are useful links and resources:

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 ReportThe 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). 

National Biomarker Development Alliance (NBDA)

Unknown Hazard Reduction

RUSH College Football Ratings

International Society for Bayesian Analysis (ISBA)

ISBA's New Section on Biostatistics and Pharmaceutical Statistics

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

Guidance Reports:
The Clinical Trials Transformation Initiative's (CTTI) Recommendations for Data Monitoring Committees

President's Council of Advisors on Science and Technology (PCAST) released its latest report:  Report to the President on Propelling Innovation in Drug Discovery, Development, and Evaluation

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FDA's Draft Guidance for Adaptive Design Clinical Trials for Drugs and Biologics