Evaluation of the Fill-it-up-design to use historical control data in randomized clinical trials with two arm parallel group design.

ABSTRACT:

Purpose

In the context of clinical research, there is an increasing need for new study designs that help to incorporate already available data. With the help of historical controls, the existing information can be utilized to support the new study design, but of course, inclusion also carries the risk of bias in the study results.

Methods

To combine historical and randomized controls we investigate the Fill-it-up-design, which in the first step checks the comparability of the historical and randomized controls performing an equivalence pre-test. If equivalence is confirmed, the historical control data will be included in the new RCT. If equivalence cannot be confirmed, the historical controls will not be considered at all and the randomization of the original study will be e

SUBMITTER: Wied S 

PROVIDER: S-EPMC11382532 | biostudies-literature | 2024 Sep

REPOSITORIES: biostudies-literature