Randomized controlled trials: who fails run-in?

ABSTRACT:

Background

Early identification of participants at risk of run-in failure (RIF) may present opportunities to improve trial efficiency and generalizability.

Methods

We conducted a partial factorial-design, randomized, controlled trial of calcium and vitamin D to prevent colorectal adenoma recurrence at 11 centers in the United States. At baseline, participants completed two self-administered questionnaires (SAQs) and a questionnaire administered by staff. Participants in the full factorial randomization (calcium, vitamin D, both, or neither) received a placebo during a 3-month single-blinded run-in; women electing to take calcium enrolled in a two-group randomization (calcium with vitamin D, or calcium alone) and received calcium during the run-in. Using logistic regression m

SUBMITTER: Rees JR 

PROVIDER: S-EPMC4966775 | biostudies-literature | 2016 Jul

REPOSITORIES: biostudies-literature