© 2018 Trials within Cohorts    Contact: c.relton@qmul.ac.uk.  Supported  by  Wellcome Trust grant and the NIHR CLAHRC for Yorkshire & Humber 

DAY ONE - Identifying questions, learning from experience

9.30-10.00

Registration and drinks

 

10.00-10.15

Welcome and introduction 

CHAIR: Professor Jon Nicholl,  University of Sheffield, UK

 

10.15-10.40

What is the TwiCs design, and how is it being used?

Dr Clare Relton, ScHARR

University of Sheffield, UK

10.40-11.00

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

Professor Merrick Zwarenstein,

Western University, Canada

11.00-11.15

Tea and coffee

 

11.15-12.00

KEY NOTE TALK

Randomisation without consent in RCTs – review of use (and terminology discussion)

 

Professor James Flory

Weill Cornell Medical College, USA

12.00–12.30

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

 

Dr Rudolf Uher

Dalhousie University, Canada

12.30-1.00

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

 

Professor Anne May,

UMC Utrecht, Netherlands

1.00-2.00

Lunch break and poster session 1

 

 

CHAIR: Professor James Flory, Weill Cornell Medical College, USA

 

2.00-2.50

KEY NOTE TALK

Ethical Issues in TwiCs and other Pragmatic Trial Designs: An Overview

 

Professor Scott Y Kim

Dept of Bioethics, National institutes of Health (NIH), USA

2.50-3.20

KEYNOTE TALK

The ethics of inefficiency

 

Professor Shaun Treweek

University of Aberdeen, UK

3.20-3.40

Tea and coffee

 

3.40-4.10

TwiCS and big data: opportunities and challenges

 

Professor Tjeerd Van Staa

University of Manchester, UK

4.10-4.30

Patient-reported outcomes in routine care:

impact for TwiCs

 

Dr Andrew Vickers

Memorial Sloan Kettering Cancer Centre, USA

4.30-5.30

PANEL DISCUSSION

Where do we go from here?

5.30

End of day one

…..Going forward

 

Time

Item

Lead

9.00-9.30

Registration and refreshments

 

9.30-9.45

Welcome, introduction and recap

Chair – Professor Helena Verkooijen,

Utrecht Medical Centre, Netherlands

9.45-10.15

HRA guidance policy and strategy on Informed Consent for simple and efficient trials.  

Randomisation without consent: survey of UK RECs

Clive Collett, Amanda Hunn

UK Health Research Authority

10.15-10.35

Ethics boards and consent – introduction & sharing of experiences?

 

Sophie Welch

Independent research consultant

10.35-11.15

 

KEY NOTE TALK

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, UK

11.15-11.30

Tea and coffee

 

11.30-12.00

Obtaining ethics approval for the cmRCT design from 31 ethics committees in 4 countries: a challenge?

 

Dr Linda Kwakkenbos,

McGill University, Canada

12.00-12.30

What do patients understand of the TWiCs design?

 

 

Dr Sophie Gerlich,

UMC Utrecht, Netherlands

12.30-1.00

DISCUSSION

 

 

1.00-2.00

Lunch break and poster session 2

 

 

 

CHAIR   Professor Søren Holm 

 

2.00-3.00

Future directions for research

 

Challenges for future studies in fragile patients- Joanne vd Velden,

Effectiveness & acceptability of tailored disclosure? Clare Relton

Evidence of distress related to informed consent?  Andrew Vickers

SHED Share ethical debate amongst UK RECs – Amanda Hunn

 

Introduced by

Danny Young-Afat,

UMC, Utrecht, Netherlands

 

Discussion with mini (2- 10 min) presentations

 

3.00-4.00

Panel discussion and concluding remarks

 

 

4.00

End