Antibiotic Platform Design

The ADAPT trial is an ARLG (Antibacterial Resistance Leadership Group) funded project to investigate the design of a Bayesian Adaptive platform trial for evaluating antibiotics in areas of unmet medical need. Led by Roger Lewis and Brad Spellberg, the ADAPT group has investigated trial designs to allow more efficient evaluation of antibiotics intended to treat resistant infections across a variety of infection sites (HAP, VAP, cUTI, IA). The central feature of ADAPT is a platform trial that will simultaneously evaluate multiple drugs at once, providing efficiency in control arm allocation, cleaner comparisons between drugs, and a stable network for evaluating multiple drugs over many years. The design incorporates additional innovative features such as sharing information across infection sites and early stopping of drugs at infection sites where poor (or good) performance is observed. Together these features can be used to significantly (sometimes up to 50%) reduce the sample sizes requires over a population of drugs to be evaluated, as compared to separate trials for each drug in each infection site.

The ARLG ADAPT invited participants can be found here:  Invited Participants

A summary presentation of work to date (as of July 2016) is included below:
ADAPT Summary Presentation

Links to related publications:
-- The Platform Trial - An Efficient Strategy for Evaluating Multiple Treatments

-- Efficiencies of Platform Clinical Trials: A Vision of the Future

-- I-SPY 2 - A Glimpse of the Future of Phase 2 Drug Development?

-- A Response Adaptive Randomization Platform Trial for Efficient Evaluation of Ebola Virus Treatments

-- Bayesian Hierarchical Modeling of Patient Subpopulations: Efficient Designs of Phase II Oncology Clinical Trials

For more information about the Antibiotic Platform Design and other Platform Trials, contact us here.