Participant characteristics and exclusion from phase 3/4 industry funded trials of chronic medical conditions: meta-analysis of individual participant level data.

ABSTRACT:

Objectives

To assess whether age, sex, comorbidity count, and race and ethnic group are associated with the likelihood of trial participants not being enrolled in a trial for any reason (ie, screen failure).

Design

Bayesian meta-analysis of individual participant level data.

Setting

Industry funded phase 3/4 trials of chronic medical conditions.

Participants

Participants were identified using individual participant level data to be in either the enrolled group or screen failure group. Data were available for 52 trials involving 72 178 screened individuals of whom 24 733 (34%) were excluded from the trial at the screening stage.

Main outcome measures

For each trial, logistic regression models were constructed to assess likelihood of screen failure in peop

SUBMITTER: Lees J 

PROVIDER: S-EPMC11085787 | biostudies-literature | 2024

REPOSITORIES: biostudies-literature