Overview

The Trials within Cohorts (TwiCs) approach combines observational and experimental research methods (observational cohorts + randomised controlled trials) in order to create an efficient infrastructure for the implementation of multiple trials. The approach was first described in 2010 as the ‘cohort multiple’ RCT (cmRCT) design (Relton & Nicholl et al) and subsequently refined by Young-Afat et al, (2016).  CONSORT guidelines for reporting Trials Using Cohorts and Routinely Collected Data are currently in development (Kwakkenbos et al, 2018).

Course content

This practical one-day course will provide participants with an understanding of the key features of the TwiCs approach to pragmatic trial design. 

The day will include information and guidance on how to plan studies using this approach, how to analyse TwiCs trials, different ways to approach informed consent, how to obtain HRA and MHRA approvals, and how to report TwiCs trials. Course participants will be provided with a wide range of examples of UK and international studies of the TwiCs approach (e.g. mental health, cancer, musculoskeletal diseases). We will discuss the strengths and weaknesses of the TwiCs approach compared to the standard approach to pragmatic trial design and other innovative approaches to trial design which also leverage existing databases for trials (e.g. randomised registry trials, electronic health record/ point-of-care trials, administrative trials and platform trials.)

In the afternoon there will be a ‘Your Own TwiCs’ session. In this session you will engage in small group work, and design your own TwiCs under the supervision of the tutors. Please bring any ideas and material you have from your field of research

Tutors

Dr Clare Relton - Senior Lecturer in Clinical Trials, Pragmatic Clinical Trials Unit, Queen Mary University, London

Professor Helena Verkooijen  - Professor Evaluation of Image-guided Interventions Imaging Division, University Medical Center, Utrecht, Netherlands

Who this course is for

Anyone involved in the design, conduct, analysis or reporting of pragmatic trials in the academic or NHS sector. The course will be of interest to all triallists, including principal investigators, trial managers, early career researchers and PhD students

 Location: PCTU, Yvonne Carter Building, 58 Turner Street, E1 2AB

Availability: Limited places                                                                                  

Cost: £200 external, £150 for QMUL staff                                                                                                                                                                 

For further information and to register your interest please contact pctu-courses@qmul.ac.uk