International symposium on the ethics of 'Trials within Cohorts' (TwiCs) Nov 2016, London, UK
Building on the first symposium , this second TwiCs symposium brought together both bioethicists and regulators with triallists using (or planning to use) the TwiCs approach. The objectives of the two day symposium were to share experiences of the design and good practice, discuss how TwiCs relate to the current ethical framework, provide a forum for debating ethical issues, explore the potential of the TwiCs approach to create learning healthcare environments, and to Identify future directions for conceptual and empirical research. Below are the videos, slides and posters from the event.
Introduction (and an extreme position statement)
What are TwiCs and how are they being used?
How do TwiCs trials fit into the Pragmatic/ Explanatory framework?
Randomisation without Consent
FORBOW: Experience from a prevention trial within a cohort of youth at high risk of severe mental illness
UMBRELLA FIT: Experience from a trial within a hospital based breast cancer cohort
Ethical Issues in Trials within Cohorts and other Pragmatic RCTs
The ethics of inefficiency
TwiCs and big data
Patient-reported outcomes in routine care: impact for TwiCs
TwiCs symposium - MHRA perspective
Kirsty Wydenbach - Medicines & Healthcare products Regulatory Agency (MHRA), UK Video and slides
Speaker Panel Discussion - Day One
Merrick Zwarenstein, Scott Kim, James Flory, Rudolf Uher, Clare Relton Video
Overview of day one
Applying a proportionate approach to the process of seeking consent
Randomisation without consent: survey of RECs in England
Inside the REC
Why and when should control groups consent?
Do ethical considerations relating to harm, burden, rights and reasonable expectations help us to answer this question?
Obtaining ethics approval for the cmRCT design from 39 ethics committees in 5 countries
What do patients understand of the cmRCT (TwiCs) design
Future directions for Empirical and Conceptual Research
CHAIR Danny Young-Afat - University Medical Centre (UMC), Utrecht, The Netherlands Video
cmRCT in a fragile patient population
A mental health cohort for adolescents
Trigeminal Neuralgia - medical or surgical management?
HRA endorsement of use of registries for recruitment to research
Amanda Hunn - Health Research Authority, (HRA), UK Video
Patient distress and informed consent
Some ideas for future research
Ethics Panel discussion - Day Two
Scott Kim, Søren Holm, James Flory, Clive Collett, Amanda Hunn Video
The Importance of oversigh in TwiCs: experiences from the Community Ageing Research 75+ study
Lesley Brown, Bradford Institute for Health Research, UK Poster
Ethical challenges for TwiCs in low and middle income countries
Kate Chatfield, Centre for Professional Ethics, University of Central Lancashire, UK Poster
Ethical Issues in a TwicS study in early Psoriatic Arthritis
Laura Coates et al, University of Oxford, UK Poster
Multiple trials within the cmRCT design; an example within a colorectal cancer cohort
Alice Couwenberg1, et al, University Medical Center, Utrecht, Netherlands Poster
STAR: Using the cmRCT design to for ADHD research
Philippa Fibert, University of Sheffield, UK Poster
Getting past the gatekeeper: overcoming a barrier to research participation
Emily Peckham and colleagues Poster
INVOLVEMENT: A mental health cohort for adolescents - project plan
Petter Viksveen, University of Stavanger, Norway Poster
The 2nd TwiCs international symposium was supported by funding from the Wellcome Trust and NIHR CLAHRC Yorkshire and Humber.