Incorporating external controls in the design of randomized clinical trials: a case study in solid tumors.

ABSTRACT:

Background

The use of historical external control data in clinical trials has grown in interest and needs when considering the design of future trials. Hybrid control designs can be more efficient to achieve the same power with fewer patients and limited resources. The literature is sparse on appropriate statistical methods which can account for the differences between historical external controls and the control patients in a study. In this article, we illustrate the analysis framework of a clinical trial if a hybrid control design was used after determining an RCT may not be feasible.

Methods

We utilize two previously completed RCTs in nonsquamous NSCLC and a nationwide electronic health record derived de-identified database as examples and compare 5 analysis methods on ea

SUBMITTER: Damone EM 

PROVIDER: S-EPMC11529009 | biostudies-literature | 2024 Nov

REPOSITORIES: biostudies-literature