Welcome to the TwiCs network where we share information about the Trials within Cohorts (TwiCs) approach for designing and conducting practical randomised controlled trials. The Trials within Cohorts (TwiCs) approach uses infrastructures (cohorts) to facilitate the conduct of multiple randomised controlled trials. The TwiCs approach is used by researchers working in diverse settings, including primary care, secondary care and community settings.
Key features of the TwiCs approach
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A large observational cohort of people with the condition
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Repeated measurement of outcomes for the whole cohort
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Capacity for multiple randomised controlled trials over time
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Patient-centred informed consent
The TwiCs approach was developed before the wide scale adoption of electronic health record (EHR) systems. Growing IT maturity is now enabling the integration of clinical trial infrastructure into EHR systems.
Several innovative trial designs capitalising on this new landscape by embedding the randomisation process into the EHRs, linking randomisation to the moment of clinical decision making and making that randomisation optional for the clinician DARTs - Flory et al, 2023 and PROSPECTOR - Wilson et al, 2022.
These innovative designs include exhibit all the key features of the TwiCs approach and offer the potential for rapid and efficient routine treatment comparisons at scale by streamlining trial processes within EHR systems (participant screening, consent, enrolment, randomisation, intervention delivery and data collection and outcome ascertainment).
The TwiCs approach
The term 'TwiCs' was coined at the first symposium on the 'cohort multiple RCT' (cmRCT) 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 TwiCs approach are:
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A large observational cohort of people with the condition
-
Repeated measurement of outcomes for the whole cohort
-
Capacity for multiple randomised controlled trials over time
-
Patient-centred informed consent
The advantages are that the cohort serves as a representative pool from which eligible people can be selected and approached for trial participation. This provides a platform for testing multiple interventions.
The standard approach to informed consent is the 'everything up front' approach. The TwiCs approach advocates the use of a patient-centred approach to informed consent procedure - one which is more similar to how information is provided in healthcare settings where information is staged in order to maximise relevance for the patient.
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More than 80 studies have or are using the design. Researchers in the UK, Canada, USA, France, Netherlands, Finland, and Australia; are use the TwiCs design approach 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.
This website describes key features of the TwiCs approach. There is a list of examples of use of the TwiCs approach in hospital, primary care and population settings. There are also articles discussing methodological issues, reporting guidelines, ethical questions, and the role of the TwiCs approach in relation to the development of Learning Health Systems.
Though originating in healthcare, the TwiCs approach to trial design can be used to inform decision making in any area, e.g. education, social care, crime, energy use.
