Welcome to the TwiCs network where we share information about Trials within Cohorts (TwiCs) system for designing and conducting practical randomised controlled trials.
HOT PRESS
Descriptive, ethical & US regulatory analysis of the TwiCs design "Ethics and practice of Trials within Cohorts" S Kim, J Flory, C Relton
First approved CTIMP using TwiCs design - ASSESS - meso led by Anna Bibby at Bristol University.
First completed TwiCs trials published: Viksveen et al, 2017 and Viksveen et al, 2017; Cockayne et al, 2017
Forthcoming events
Introduction to TwiCs (One day course)
PCTU, Queen Mary University, London
27th April 2019
Past events
MRC HTMR Trial Conduct Webinar
2nd International Symposium on Ethics of TwiCs (ppts and videos, and full published report)
CONSORT REPORTING GUIDELINES due 2020
Extension to Improve Reporting of Trials Using Observational Cohorts, Registries and Routinely Collected Health Data
(Funded by the Canadian Institutes of Health Research and the UK NIHR Clinical Trials Unit Support Funding)
The design (Trials within Cohorts)
Trials within Cohorts (TwiCs) embed one or more randomised controlled trials within cohorts.
The term 'TwiCs' was created for the first symposium on the 'cohort multiple RCT' design. This approach to trial design (the cmRCT design) was first described in the BMJ in 2010 article in the context of healthcare. Key features of the cmRCT design are:
(I) A large observational cohort of people with the condition
(II) Regular measurement of outcomes for the whole cohort
(III) Capacity for multiple randomised controlled trials over time
The advantages of the design are that the cohort serves as a representative
pool from which eligible people can be selected and approached for trial
participation and a platform in which multiple interventions
can be tested simultaneously (efficient use of control patients, improved
comparison between different interventions) and contamination between
study arms is minimised. As the design uses patient-centred informed
consent procedure this is expected to lead to higher, more representative
recruitment.
-
Since it's publication, more than 20 studies have started using the design in
the UK, Canada, USA, France, Netherlands, Finland, and Australia; creating
systems to help address questions in a variety of fields (breast cancer,
bone metastases, rectal cancer, mental health, care of the elderly,
rare diseases, etc). The design is now being used to trial both
medicinal products (CTIMPs) and non-medicinal products.
Though originating in healthcare, the TwiCs approach to trial design can of course be used to inform decision making in any area, e.g. education, social care, crime, energy use.
This website describes key features of the TwiCs approach and links to articles describing the methodologies, and examples of use of the TwiCs
approach in hospital settings and primary care/ population based settings.
