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01.12.2018 | Commentary | Ausgabe 1/2018 Open Access

Trials 1/2018

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

Zeitschrift:
Trials > Ausgabe 1/2018
Autoren:
Anna C. Bibby, David J. Torgerson, Samantha Leach, Helen Lewis-White, Nick A. Maskell
Wichtige Hinweise

Electronic supplementary material

The online version of this article (doi:https://​doi.​org/​10.​1186/​s13063-017-2432-3) contains supplementary material, which is available to authorized users.

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 a two-stage consent process and using the consent stages to explicitly differentiate between trial participants and cohort participants who are providing control data. This distinction ensured compliance but had consequences with respect to costings, recruitment and the trial assessment schedule.

Conclusion

We have demonstrated that it is possible to secure ethical and regulatory approval for a CTIMP TwiC. By including certain considerations at the trial design stage, we believe this pragmatic and efficient methodology could be utilised in other CTIMPs in future.
Zusatzmaterial
Additional file 1: TILT summary and trial flow chart. (DOCX 103 kb)
13063_2017_2432_MOESM1_ESM.docx
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