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The 2nd 'Trials within Cohorts' (TwiCs) international symposium is being held in London supported by the Wellcome Trust and CLAHRC Yorkshire and Humber. This symposium will explore the ethical issues relating to TwiCs - particularly the ‘cohort multiple RCT’ (cmRCT) design, a design which embeds multiple trials within a cohort or register, tailoring the information disclosed to participants according to their group allocation.
Building on the first TwiCs symposium (2014), this second symposium brings together triallists, leaders in bioethics, informed consent research and ethics board experts to discuss and debate key ethical questions relating to the design:
- o Should patients be told about treatments that they will have no access to if they are in the usual care control group?
- o What should people ‘in a trial’ be told if their care is not affected in anyway by the trial?
- o Should people be told prospectively (or retrospectively) that their treatment will decided by chance?
Triallists with experience of TwiCs designs in a range of healthcare settings (hospital and primary care) will describe and discuss their experiences with ethics boards, trial funders, clinicians, the public and patients, and methodological research in relation to the TwiCs approach..
This symposium will contribute to the future direction of pragmatic trial design and ethics research in this field.
The symposium objectives are to:
o Share experiences of the design from key perspectives (patients, clinicians, ethics boards, ethicists)
o Share good practice
o Discuss how TwiCs relate to the current ethical framework
o Provide a forum in which to discuss and debate ethical issues
o Explore the potential of TwiCs approach to transform healthcare systems into learning healthcare environments.
o Identify future directions for conceptual and empirical research
Professor James Flory - Cornell University (Weill Cornell Medical College - Graduate School - Medical Sciences)
Professor Scott Kim - Department of Bioethics, NIH, USA
Professor Rudolf Uher - Dalhousie University (Department of Psychiatry)
Prof Merrick Zwarenstein - Western University (Department of Family Medicine)
Professor Lenny Verkooijen,- Utrecht Medical Centre
Professor Anna May,- Utrecht Medical Centre
Dr Joanne van der Velden - Utrecht Medical Centre
Professor Jon Nichol - University of Sheffield (ScHARR)
Dr Clare Relton - University of Sheffield (ScHARR),,
Professor Shaun Treweek - University of Aberdeen (HSRU),
Amanda Hunn & Clive Collett - Health Research Authority (HRA),
Professor Soren Holm - University of Manchester (School of Law - Healthcare Ethics and Law)
Sophie Welch - indpendent research consultant