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. 

                                                                                                                  

 DAY ONE

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Introduction (and an extreme position statement)

CHAIR    Professor Jon Nicholl - University of Sheffield (ScHARR), UK      Video and slides

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What are TwiCs and how are they being used?

Dr Clare Relton - University of Sheffield (ScHARR), UK        Video and slides

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How do TwiCs trials fit into the Pragmatic/ Explanatory framework?  

Professor Merrick Zwarenstein - Western University (Department of Family Medicine),  Ontario, Canada      Video and slides

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Randomisation without Consent

Professor James Flory - Cornell University (Weill Cornell Medical College), New York, USA     Video and slides

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FORBOW: Experience from a prevention trial within a cohort of youth at high risk of severe mental illness

Dr Rudolf Uher - Dalhousie University, Nova Scotia, Canada   Video and slides

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UMBRELLA FIT: Experience from a trial within a hospital based breast cancer cohort

Professor Anne May,- University Medical Centre (UMC), Utrecht, The Netherlands    Video and slides

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Ethical Issues in Trials within Cohorts and other Pragmatic RCTs

Professor Scott Kim - Department of Bioethics, NIH, USA    Video and slides

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The ethics of inefficiency

Professor Shaun Treweek - University of Aberdeen (HSRU), Scotland, UK   Video and slides

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TwiCs and big data

Professor Tjeerd Van Staa - University of Manchester, UK    Video and slides

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Patient-reported outcomes in routine care: impact for TwiCs

Dr Andrew Vickers - Memorial Sloan Kettering Cancer Centre, USA        Video and slides

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TwiCs symposium - MHRA perspective

Kirsty Wydenbach - Medicines & Healthcare products Regulatory Agency (MHRA), UK    Video and slides

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Speaker Panel Discussion - Day One

Merrick Zwarenstein, Scott Kim, James Flory,  Rudolf Uher, Clare Relton    Video

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DAY TWO

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Overview of day one

CHAIR  Professor Helena Verkooijen,- University Medical Centre (UMC), Utrecht, The Netherlands   Video and slides

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Applying a proportionate approach to the process of seeking consent

Clive Collett - Health Research Authority (HRA), UK    Video  and slides

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Randomisation without consent: survey of RECs in England

Amanda Hunn - Health Research Authority, (HRA), UK     Video and slides

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Inside the REC

Sophie Welch - independent research consultant, Scotland, UK    Video and slides

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Why and when should control groups consent? 

Do ethical considerations relating to harm, burden, rights and reasonable expectations help us to answer this question?

Professor Søren Holm  - University of Manchester (School of Law - Healthcare Ethics and Law), UK     Video and slides

 

Obtaining ethics approval for the cmRCT design from 39 ethics committees in 5 countries

Dr Linda Kwakkenbos  -   McGill University, Canada    Video and slides

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What do patients understand of the cmRCT (TwiCs) design

Dr Sophie Gerlich  -  University Medical Centre (UMC), Utrecht, The Netherlands     Video and slides

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MINI TALKS

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

Dr Joanne Van Der Velden -  University Medical Centre (UMC), Utrecht, The Netherlands   Video and slides

A mental health cohort for adolescents 

Dr Petter Viksveen -  Univeristy of Stavanger, Norway   Video and slides

Trigeminal Neuralgia - medical or surgical management?

 Dr Joanne Zakrewska  -  Pain Management Centre, UCLH NHS Foundation Trust, London, UK   Video and slides

HRA endorsement of use of registries for recruitment to research

Amanda Hunn -  Health Research Authority, (HRA), UK   Video 

Patient distress and informed consent

Dr Andrew Vickers - Memorial Sloan Kettering Cancer Centre, USA   Video and slides

Some ideas for future research

Dr Clare Relton - University of Sheffield (ScHARR), UK   Video and slides

 

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Ethics Panel discussion - Day Two

Scott Kim, Søren Holm, James Flory,  Clive Collett, Amanda Hunn   Video​

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POSTERS 

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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

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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

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STAR: Using the cmRCT design to for ADHD research

Philippa Fibert, University of Sheffield, UK    Poster

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Getting past the gatekeeper: overcoming a barrier to research participation

Emily Peckham and colleagues   Poster 

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INVOLVEMENT: A mental health cohort for adolescents - project plan

Petter Viksveen, University of Stavanger, Norway       Poster 

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