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

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

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 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

• Introduction to the theme
  Charles Weijer, Western University, Canada
• Case study 1: Ethical issues of the PolyIran study: A cluster randomized trial nested within Golestan cohort study
  Gholamreza Roshandel, Golestan Research Center of Gastroenterology and Hepatology, Iran
• Case study 2: Lessons from an adaptive multi-arm multi-stage trial of strategies for improving linkage into HIV care or prevention in Malawi
  Augustine Choko, Malawi-Liverpool Wellcome Trust Clinical Research Programme/London School of Hygiene & Tropical Medicine, UK

 

Theme 2: Stepped wedge

• Introduction to the theme
  Rieke van der Graaf, University Medical Centre Utrecht, Netherlands
• Case study 3: ‘¡Que Vivan Las Madres!’: Scaling up an integrated approach to reduce maternal and perinatal mortality in Northern Guatemala – A stepped-wedge cluster randomised trial (SW-CRT)
  Karla Hemming, University of Birmingham, UK and Guillermo Ambrosio, Epidemiological Research Centre in Sexual and Reproductive Health (CIESAR), Guatemalan Ministry of Public Health
  
• Case study 4: ATMIYATA: Testing effectiveness of counselling delivered by community volunteers to people with common mental health issues in rural parts of Gujarat, India: Step Wedged Cluster Randomized Trial (SWCRT)
  Kaustubh Joag, Indian Law Society

 

Theme 3: Adaptive platforms

• Introduction to the theme (video only)
  Ross Upshur, University of Toronto, Canada
• Case study 5: The design and implementation of an adaptive platform trial for the treatment of Ebola in West Africa
  Scott Berry, Berry Consultants, USA
• Case study 6: Critically ill children and adaptive trials for comparative effectiveness research
  Srinivas Murthy, University of British Columbia, Canada 

 

Pecha Kucha

• Alternative clinical trial designs for research on hypertensive disorders of pregnancy in low resource settings
  Shivaprasad Goudar, KLE University’s Jawaharlal Nehru Medical College, India
• A quantitative framework for balancing ethical tradeoffs in vaccine study design during highly fatal, emerging infectious disease epidemics
  Steven Bellan, University of Georgia, USA
• Ethical issues of alternative clinical trial designs and methods in Myanmar
  Khine Zaw Oo, Defence Services Medical Research Centre, Myanmar 
• Alternate to clinical trial design for Ayurveda in chronic non-communicable diseases, in non-emergency settings
  Vina Vaswani, Yenepoya University Mangalore, India
• Paving the way: Better understanding of the Egyptian research ethics committees, and regulatory authority for alternative clinical trial designs
  Hany Sleem, National Hepatology and Tropical Medicine Research Institute, Egypt
• Ethics of alternative clinical trial methods in LMIC research: The Gambia Hepatitis Intervention Study experience (GHIS)
  Gibril Ndow, Imperial College London/MRC Unit The Gambia

 

Summary of day 1

• Anant Bhan, Yenepoya Medical College, India
• Teck Chuan Voo, National University of Singapore

 

Theme 4: Controlled human infection models

• Introduction to the theme
  Nick Day, Mahidol Oxford Tropical Medicine Research Unit, Thailand
• Case study 7: Control of invasive Salmonella in Africa and Asia – Is there a role for establishing controlled human infection models in endemic countries?
  Meriel Raymond, Oxford University, UK
• Case study 8: Experiences and perceptions of study participants in a malaria challenge study in Kilifi, Kenya
  Dorcas Kamuya, KEMRI-Wellcome Trust Research Programme, Kenya
• Case study 9: The case of Zika virus human challenge studies
  Ricardo Palacios Gomez, Butantan Institute, Brazil

 

Theme 5: Current guidance and regulation: Regional perspectives

• Current international ethical guidance and regulations on use of alternative research designs
  Rieke van der Graaf, University Medical Centre Utrecht, Netherlands
• CHIMS: What does it mean to be a responsible research funder?
  Katherine Littler, Wellcome, UK
  
• Response from different regional perspectives and open discussion (video only):
  • East Africa – Claude Kirimuhuzya, Kampala International University, Uganda
  • Caribbean – Derrick Aarons, Caribbean Public Health Agency, Trinidad and Tobago
  • Latin America – Carla Saenz, Pan American Health Organisation, USA
  • Southeast Asia – Cristina Torres, Forum for Ethical Review Committees in the Asian and Western Pacific Region, Philippines

 

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

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.