12th Forum – Bangkok, Thailand, 28-29 November 2017

Theme of the Meeting
Ethics of alternative clinical trial designs and methods in LMIC research
Organisers
The Wellcome Trust and Mahidol Oxford Tropical Medicine Research Unit

 

Supported by:

  • The Wellcome Trust
  • Medical Research Council-United Kingdom (MRC UK)
  • Bill & Melinda Gates Foundation
  • National Institutes of Health

Planning Committee

Members of the Planning Committee for this meeting were:

  • Phaik Yeong Cheah, The Mahidol Oxford Tropical Medical Research Unit (MORU), Thailand;
  • Nicholas Day, MORU, Thailand;
  • Katherine Littler, Wellcome Trust, UK;
  • Patricia Njuguna, KEMRI-Wellcome Trust programme, Kenya;
  • Annette Rid, King’s College London, UK;
  • Patricia Saidón, Instituto de Investigación en Salud Pública (IDISA), Argentina;
  • Ross Upshur, University of Toronto, Canada;
  • Rieke van der Graff, University Medical Center Utrecht, Netherlands;
  • Charles Weijer, Western University, Canada.

 

Programme and Presentations

Programme details

Click here to view the conference booklet, including case study summaries.

 

Presentations

Videos of the presentations are available here.

 

Keynote: HIV prevention trials in the era of PREP: Impact on trial designs and the ethics of standard of care in low/middle income settings
Glenda Gray, South African Medical Research Council

 

Theme 1: Cluster randomised trials

 

Theme 2: Stepped wedge

 

Theme 3: Adaptive platforms

 

Pecha Kucha

 

Summary of day 1

 

Theme 4: Controlled human infection models

 

Theme 5: Current guidance and regulation: Regional perspectives

 

Theme 6: Current guidance and regulation: Gaps and creative solutions

  • Informing ethical evaluations of adaptive clinical trials through simulation
    Roger Lewis, University of California, USA
  • Panel and open discussion (video only):
    • Rieke van der Graaf, University Medical Centre Utrecht, Netherlands
    • Roger Lewis, University of California, USA
    • Phaik Yeong Cheah, Mahidol Oxford Tropical Medicine Research Unit, Thailan
    • Charles Weijer, Western University, Canada
    • Patricia Saidon, Instituto de Investigación en Salud Pública Argentina

 

Key themes panel (video only)

  • Paul Ndebele, Medical Research Council, Zimbabwe
  • Anant Bhan, Yenepoya Medical College, India
  • Carla Saenz, Pan American Health Organisation, USA
  • Rachel Knowles, Medical Research Council, UK
  • Mike Parker, Oxford University, UK

 

Conclusions, presentation of poster award and GFBR award (video only)

  • Paul Ndebele, Medical Research Council, Zimbabwe and Anant Bhan, Yenepoya Medical College, India

Reports
A background paper was prepared in advance of the meeting and provides an overview of the field and the key ethical issues raised by this important topic.

A meeting report is available, along with a slide deck that participants are very welcome to use when presenting on the meeting back home.

In addition, the papers from this meeting were published in a two part Supplement in Trials. Part 1 contains an Editorial, the meeting summary and papers on stepped wedge cluster randomised trial design and controlled human infection models. Part 2 contains a paper on cluster randomised trials.

We are very interested to hear about participants’ post-meeting activities. Please do keep us up-to-date by emailing gfbr@wellcome.ac.uk.


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