Commentary: considerations for using the 'Trials within Cohorts' design in a clinical trial of an investigational medicinal product.

ABSTRACT:

Background

The 'trials within cohorts' (TwiC) design is a pragmatic approach to randomised trials in which trial participants are randomly selected from an existing cohort. The design has multiple potential benefits, including the option of conducting multiple trials within the same cohort.

Main text

To date, the TwiC design methodology been used in numerous clinical settings but has never been applied to a clinical trial of an investigational medicinal product (CTIMP). We have recently secured the necessary approvals to undertake the first CTIMP using the TwiC design. In this paper, we describe some of the considerations and modifications required to ensure such a trial is compliant with Good Clinical Practice and international clinical trials regulations. We advocate using

SUBMITTER: Bibby AC 

PROVIDER: S-EPMC5759253 | biostudies-literature | 2018 Jan

REPOSITORIES: biostudies-literature