Post-traumatic Stress Disorder-Drug Treatment (PTSD-DT) Adaptive Platform Trial (APT)
This program aims to support the development and maintenance of clinical trial infrastructure for the simultaneous and sequential testing of drug interventions to treat post-traumatic stress disorder (PTSD) in an adaptive platform trial (APT) design. The PTSD APT will test a minimum of two drugs versus a placebo in a platform design, which allows for replacement of drugs based on pre-defined rules for success or futility. Adaptive platform trials are often based on Bayesian statistical models with multiple features that improve trial efficiency and decision-making. The requirement for this program includes three focus areas.
- • Focus Area #1 (Statistical Modeling): Trial design, simulation, initiation, and execution, including drafting of key documents (e.g., statistical sections of Master Protocol, Statistical Analysis Plan, Operational Plan).
- • Focus Area #2 (Drug Selection): Operationalization and execution of a drug selection process for initial and continual selection of interventions to be tested in the APT.
- • Focus Area #3 (Clinical and Clinical Operations): Completion of the APT design, development of clinical trial infrastructure, and execution of the APT.
Project proposals are currently under evaluation. The research project award recipients will be selected from the Offerors who responded to MTEC’s Request for Project Proposals (MTEC 20-11-PTSD-DT).