Advancing Inclusion of Pregnant and Lactating Women in Clinical Trials in Low- and Middle-Income Countries (LMICs)

Lester Chinery of Concept Foundation in Switzerland with Medicines for Malaria Venture will support creation of an LMIC collaboration that enables inclusion of pregnant and lactating women in LMIC clinical trials, so these women will have broad access to well-studied, effective, and safe medical products. The need for such trials and pregnancy-related equitable access arises because of pregnancy-specific conditions, new or pre-existing illnesses in pregnancy, and the impact of pregnancy itself on medicines and their effects. The collaboration will be initiated through a meeting to explore the issue by understanding the perspectives of LMIC regulators, including their views on the barriers and the required data to overcome them. The meeting will also integrate the recommendations of relevant ongoing international initiatives, including determining how to implement the most urgent recommendations in LMICs. The next step would be creation of an LMIC task force to build and sustain momentum.