Designing a response-over-continuous-intervention (ROCI) randomised trial: Implementation in the Phase 2C part (duration ranging) of the PARADIGM4TB trial.

ABSTRACT:

Background/aims

Treatments for tuberculosis (TB) are often long and complicated. Standard 2-arm non-inferiority trials have been used to evaluate shorter durations of treatment regimens. The new response-over-continuous-intervention (ROCI) trial design has recently been proposed as a practical alternative for optimising some continuous aspect (e.g. treatment duration) of treatment administration.

Methods

We demonstrate the use of simulation for designing a ROCI trial in the TB setting. We use the Phase 2C part (duration ranging) of the PARADIGM4TB trial as a case study to illustrate the simulation procedure and the important design considerations to be explored in simulation. Phase 2C of PARADIGM4TB aims to optimise durations of novel treatment regimens, compared to a 6-mont

SUBMITTER: Pham TM 

PROVIDER: S-EPMC7619081 | biostudies-literature | 2025 Aug

REPOSITORIES: biostudies-literature