Wellcome Trust and EDCTP will sponsor a symposium as part of the programme of the American Society for Tropical Medicine and Hygiene’s annual conference.
Dr Pauline Beattie (EDCTP) and Professor Mike Turner (Wellcome Trust) will chair the session with the following speakers:
Ruth Faden (Berman Institute of Biomedical Ethics, Johns Hopkins University, USA): ‘Social, ethical and legal implications of research in pregnant women during the Zika outbreak’;
Khátia Munguambe (University Eduardo Mondlane & Centre for Health Research of Mozambique, Mozambique):
‘Community engagement in the context of clinical trials on reproductive health’and child health’.
Victor Mwapasa (College of Medicine-University of Malawi, Malawi): ‘
Practical challenges with implementing studies involving pregnant women in an African setting with high HIV and malaria prevalence’;
Rose McGready (University of Oxford and Shoklo Malaria Research Unit, Thailand):
‘Effects of malaria and other tropical infections on maternal and child heath’.
Conducting clinical trials in low and middle income countries (LMICs) is essential to deliver new and improved medical interventions that are safe, effective, appropriate and accessible for the affected population. Pregnant women and their unborn children in LMICs are particularly vulnerable to a range of infections that can lead to significant mortality and morbidity to mother and baby. There is a need to develop medical products to prevent and treat infection in pregnancy and that can be implemented effectively in LMICs.
However, the systematic exclusion of pregnant women from clinical trials conducted by product developers, as well as the challenges (scientific, ethical, social, cultural) of conducting research in pregnant women limit the development, testing and approval of safe, affordable and effective products for pregnant women. Furthermore, such trials can be costly and of long duration where extended infant follow-up post-trial is included. There is a need to maximise the impact of research through collaboration and data sharing from individual trials conducted in pregnant women.
This symposium focuses on the practical challenges faced and lessons learned by researchers conducting clinical trials in pregnant women in LMICs. The presentations will focus on malaria, HIV and Zika infection in pregnant women and will share practical experiences from sub-Saharan Africa (Malawi and Mozambique), Asia (Thailand) and South America (Brazil).
The symposium will include a final discussion session to summarize recommendations on best practice for conducting clinical trials in pregnant women, including consideration of good participatory practices, ethical and social aspects, as well as how such research can best be conducted in a collaborative network (North and South).
The symposium should be of interest to individuals and organisations dealing directly with clinical trials in LMICs and working in the field of maternal and child health.