Overrunning in clinical trials: some thoughts from a methodological review.

ABSTRACT:

Background

In sequential and adaptive trials, the delay that happens after the trial is stopped, by a predetermined stopping criterion, takes the name of overrunning. Overrunning consists of extra data, collected by investigators while awaiting results of the interim analysis (IA). The inclusion of such extra data in the analyses is scientifically appropriate and follows regulatory advice. Nevertheless, its effect from a broader perspective is unclear.

Methods

This article aims at clarifying the overall impact of including such overrunning data, providing first a revision, and then a comparison of the several approaches proposed in the literature for treating such data. A simulation study is performed based on two real-life examples.

Results

The paper shows that overr

SUBMITTER: Baldi I 

PROVIDER: S-EPMC7374901 | biostudies-literature | 2020 Jul

REPOSITORIES: biostudies-literature