A retrospective analysis of conditional power assumptions in clinical trials with continuous or binary endpoints.

ABSTRACT:

Background

Adaptive clinical trials may use conditional power (CP) to make decisions at interim analyses, requiring assumptions about the treatment effect for remaining patients. It is critical that these assumptions are understood by those using CP in decision-making, as well as timings of these decisions.

Methods

Data for 21 outcomes from 14 published clinical trials were made available for re-analysis. CP curves for accruing outcome information were calculated using and compared with a pre-specified objective criteria for original and transformed versions of the trial data using four future treatment effect assumptions: (i) observed current trend, (ii) hypothesised effect, (iii) 80% optimistic confidence limit, (iv) 90% optimistic confidence limit.

Results

The hypo

SUBMITTER: Edwards JM 

PROVIDER: S-EPMC10035140 | biostudies-literature | 2023 Mar

REPOSITORIES: biostudies-literature