Table 1.

Basic framework to accelerate clinical data generation for antiretroviral use in pregnancy

	Action item
1	Develop a pregnancy data acceleration plan for each early-stage compound
2	Accelerate completion of reproductive toxicity assessments (EFD, PPND and FEED) and accelerate pharmacokinetic and modelling assessments
3	Phase 1b and 2 trials: include more individuals of childbearing potential (contraception or sterilization required) to allow meaningful data collection; must discontinue if pregnancy occurs
4	Phase 3 trials: recommend, but do not require, use of contraception by individuals of childbearing potential
5	Phase 3 trials: once effective dosing in individuals of childbearing potential is established and sufficient safety data are known, allow individuals to continue treatment if they become pregnant
6	Develop a regulatory strategy for each compound, and engage relevant health authorities through development (usual process) to align on process for an evidence-based pregnancy data acceleration plan; align early, if possible, on labelling options and requirements
7	Develop a data collection and statistical strategy for each compound that allows for early and consistent participation of individuals of childbearing potential in clinical studies, and for data handling options for individuals who become pregnant in phase 3 (e.g. sample size adjustments, pre-specified analysis plans, sensitivity analyses for primary or secondary endpoints, pharmacokinetic sampling strategies and study extension into the postpartum period)
8	Consider planning a dedicated trial during pregnancy and lactation to be conducted once sufficient safety data are available from phase 3 (pre- or post-approval)
9	Engage and consult with community representatives early and consistently
10	Publish data as early as possible to inform decision-making by healthcare providers

EFD embryo-foetal development, FEED fertility and early embryonic development, PPND pre- and post-natal development