Framework for accelerated inclusion of pregnant women in pre-licensure clinical trials

Goal

Pharmacokinetic and preliminary safety data on all new HIV agents in pregnancy to be available when a drug is approved. 

The framework includes the following key principles:

  • Involve women of childbearing potential affected by HIV from the identification of research questions through the study design, recruitment, conduct and dissemination of results.
  • Perform non-clinical developmental and reproductive toxicology studies earlier during drug development for all new HIV agents.
    • Fertility and early embryonic development and embryo- fetal development studies should be completed during or no later than the end of the Phase 2 registrational trials.
    • Pre- and postnatal development studies should be completed during early phase 3 or no later than the end of the Phase 3 registrational trial.
  • Women who become pregnant in pre-licensure trials should be given the option to make an informed choice to stay on the study drug once early non-clinical fertility and early embryonic development and embryo-fetal development studies are completed, with no negative signals and dosing being established in non-pregnant women.
  • Enrol pregnant women in specific studies to determine pregnancy pharmacokinetic and preliminary safety, as soon as late non-clinical pre- and postnatal development studies are completed with no negative signals, for all new HIV agents.
  • Investigate adverse pregnancy and birt=h outcomes through dedicated pregnancy safety studies for all new priority HIV agents identified through the Conference on Antiretroviral Drug Optimization as soon as dosing in pregnancy is confirmed.
  • Expand the active surveillance of drug safety in pregnancy to enable systematic and rapid detection of adverse maternal, pregnancy and birth outcomes, especially rare events such as birth defects.