PAHO’s Regional Program on Bioethics and Quality and Regulation of Medicines and Health Technologies Unit offered a new seminar in the series focused on clinical trials.
This session addressed key aspects and regional challenges for the ethical inclusion of pregnant participants in clinical trials.
English-Spanish translation was available.
The videos from previous seminars are available from PAHO's Portal of Clinical Trials of the Americas.
- To examine critical ethical considerations and region-specific challenges associated with the inclusion of pregnant women in clinical trials
PRELIMINARY AGENDA
Welcome and Opening
Carla Saenz (PAHO) opens the session.
Presentations:
- Carla Saenz – Regional progress and challenges in conducting research with pregnant participants (10 minutes)
- Flor Muñoz – The role of clinical trials during pregnancy in promoting maternal and child health (15 minutes)
- Carleigh Krubiner – Weighing risks and benefits in pregnancy-related research (15 minutes)
- Christiane Santiago Maia – Key aspects of ICH E21 for research involving pregnant participants and challenges in its implementation (15 minutes)
Panel Discussion and Audience Q&A (1 hour)
Moderator: Sarah Carracedo
Following these presentations, all the speakers will have approximately one hour of discussion. This will be conducted in an informal, conversational format, drawing on questions submitted by attendees throughout the session.
Closing Remarks
Carla Saenz
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Panelists |
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Flor M. Munoz, MD Associate Professor of Pediatrics, Infectious Diseases Molecular Virology and Microbiology Baylor College of Medicine Transplant Infectious Diseases Texas Children’s Hospital
Flor M. Muñoz, MD, MSc, is an associate professor of pediatrics, infectious diseases, and molecular virology and microbiology at Baylor College of Medicine and Texas Children’s Hospital in Houston, TX. She also chairs the institutional review board at Baylor College of Medicine. She is a physician-scientist with research activities focusing on the evaluation of vaccine safety and efficacy in special populations including pregnant women, children, and people with compromised immune systems, as well as the epidemiology and treatment of respiratory pathogens such as RSV, influenza, SARS-CoV2, and pertussis. She is a member of the NFID Board of Directors and serves on the Vaccines and Related Biological Products Advisory Committee of the Food and Drug Administration.
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Carleigh Krubiner Bioethics and Global Health Policy Expert | Bioethics Lead at Wellcome Trust, London, UK.
Krubiner is the Bioethics Lead at Wellcome. In this role, she helps proactively embed consideration of the ethical, social, and cultural dimensions of research as an underpinning approach to how we support science and improve health for everyone. She also oversees a portfolio of strategic investments in global bioethics infrastructure and community building, which includes various professional bioethics networks, funded research centres, and global convenings.
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Christiane Santiago Maia Specialist in Regulation and Health Surveillance.
She is a nurse with a PhD in health sciences. She has been working at Anvisa (Brazilian Health Regulatory Agency) for 20 years and she is representing Anvisa in the Experts Working Group of the ICH E21 Guide.
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