Introduction

Pregnant and breastfeeding women have traditionally been excluded from clinical trials of new drugs, including antiretrovirals for HIV treatment and prevention and medicines for treating hepatitis and sexually transmitted infections (STIs). This has led to a lack of safety data and long delays in access to medicines for use in these populations.

Over the past few years multiple stakeholder groups have expressed concerns about the exclusion of these populations from clinical studies and have voiced support for a more considered and inclusive approach. The key issues are discussed in detail in a JIAS supplement on approaches to enhance and accelerate investigation of new HIV drugs in pregnancy. 

Building on the work of the United States Task Force on Research Specific to Pregnant Women and Lactating Women (PRGLAC) and the Pregnancy and HIV/AIDS: Seeking Equitable Study (PHASES) project, WHO and IMPAACT convened 2 workshops in 2020 and 2021. These resulted in the publication of a call to action and development of specific guidance on the timing and design of studies of new drugs for treating and preventing HIV and other conditions in pregnant women. A new framework to accelerate the inclusion of pregnant and breastfeeding women in pre-licensure clinical trials was developed, with the goal of having pharmacokinetic (PK) and preliminary safety data on all new HIV agents in pregnancy available at the time of drug approval. 

To facilitate a shift in practice, several strategic actions have been put forward, including the idea of a toolkit for research in pregnancy and breastfeeding. The purpose of this living toolkit is to support researchers, programme implementers and other stakeholders by providing an inventory of materials to enable inclusion and collection of data on pregnant and breastfeeding women within clinical studies and other research settings.

In this toolkit, although the terms ‘woman’ and ‘mother’ are used, we recognise that some people who experience pregnancy do not identify as women or mothers. This toolkit is meant to be inclusive of all who experience pregnancy, regardless of their gender identity.

While most documents provided here come from the HIV prevention and treatment fields, many will have value for those engaged in research in other disease areas. The intention is to expand the toolkit to encompass additional study materials and resources from the STI and viral hepatitis fields. New materials will be added as they become available.

Objectives

The objectives of this toolkit are:

1. to provide access to supporting documentation on the rationale for and ethics of including pregnant and breastfeeding women in research;
2. to provide a repository of materials to enable and support the inclusion of pregnant and breastfeeding women in research; and
3. to facilitate collection of pregnancy and breastfeeding data by providing guidance on standardized measurements and definitions relating to pregnancy and breastfeeding exposures and outcomes.  

Partnerships and funding

This project is supported by WHO with input from an international group of experts from the WHO HIV, Hepatitis and STIs Pregnancy and Breastfeeding Therapeutics Working Group. 

Key references

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Approaches to accelerating the study of new antiretrovirals in pregnancy, Abrams EJ, Calmy A, Fairlie L, et al, J Int AIDS Soc., 25: e25916.

Disrupting the status quo to achieve early inclusion of pregnant women in studies of new agents for prevention and treatment of HIV infection, Abrams EJ, Penazzato M., J Int AIDS Soc., 25: e25927.