Useful Links

Resources to advance your trials

Discover key resources to support every stage of your adaptive clinical trial journey. From Bayesian methodologies and regulatory guidance to trial design reports and software tools, these essential references provide the insights you need to design innovative, more efficient clinical trials. Equip your team with the knowledge to innovate with confidence.

Research and innovation resources

EU-PEARL

Berry Consultants were proud to be participants in the EU-PEARL project funded by the Innovative Medicines Initiative.

Innovative Clinical Trial Resource (ICTR)

Berry Consultants were proud to be participants in the EU-PEARL project funded by the Innovative Medicines Initiative.

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.

International Society for Bayesian Analysis (ISBA)

Statistical Interest Group in Medical Devices & Diagnostics (SIGMEDD) of the American Statistical Association (ASA)

Patient-Centered Outcomes Research Institute (PCORI) Methodology Reports and Selected Guidance Documents

Guidance report

PCORI’s Standards for the Design, Conduct, and Evaluation of Adaptive Randomized Clinical Trials Guidance Document provided by Berry Consultants

Guidance report

FDA’s Guidance for the Use of Bayesian Statistics in Medical Device Clinical Trials

Guidance report

FDA’s Draft Guidance for Adaptive Design Clinical Trials for Drugs and Biologics

Guidance report