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

Anna C. Bibby*, David J. Torgerson, Samantha Leach, Helen Lewis-White, Nick A. Maskell

*Corresponding author for this work

Research output: Contribution to journalComment/debate (Academic Journal)peer-review

1 Citation (Scopus)
317 Downloads (Pure)

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.

Original languageEnglish
Article number18
Number of pages6
JournalTrials
Volume19
DOIs
Publication statusPublished - 8 Jan 2018

Keywords

  • Clinical trial of an investigational medicinal product
  • Cohort multiple randomised controlled trials
  • Trials within cohorts
  • Two-stage consent

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