Distributive randomization: a pragmatic fractional factorial design to screen or evaluate multiple simultaneous interventions in a clinical trial.

ABSTRACT:

Background

In some medical indications, numerous interventions have a weak presumption of efficacy, but a good track record or presumption of safety. This makes it feasible to evaluate them simultaneously. This study evaluates a pragmatic fractional factorial trial design that randomly allocates a pre-specified number of interventions to each participant, and statistically tests main intervention effects. We compare it to factorial trials, parallel-arm trials and multiple head-to-head trials, and derive some good practices for its design and analysis.

Methods

We simulated various scenarios involving 4 to 20 candidate interventions among which 2 to 8 could be simultaneously allocated. A binary outcome was assumed. One or two interventions were assumed effective, with various

SUBMITTER: Haviari S 

PROVIDER: S-EPMC11340141 | biostudies-literature | 2024 Mar

REPOSITORIES: biostudies-literature