Over the past 5 years, multiple stakeholders have voiced their concerns around the exclusion of pregnant women from pre- and post-licensure drug trials and the associated harms and risks of these policies.
More than 19 million women are living with HIV worldwide, and many more adolescent girls and young women are at risk of acquiring HIV – the majority of whom are of childbearing age.
Information to support optimal antiretroviral drug choices in pregnancy has rarely been available for women or their health providers, largely due to historically protectionist and conservative approaches that limit inclusion of pregnant and breastfeeding women in clinical studies.
Today WHO, the International Maternal Paediatric Adolescent AIDS Clinical Trials Network (IMPAACT) and the International AIDS Society launched a call to action so women’s voices, interests and concerns are at the centre of new investigational drug trials, and so that no woman is left without informed access to innovative drugs to treat and prevent HIV.
The call to action advocates for a paradigm shift to change traditional views of pregnant women as a vulnerable population to showing them as an important population in need of HIV services who should be included in trials to test new medicines.
This effectively moves the conversation away from speaking about protecting women from research towards a discussion of how to protect women through research and promoting fair inclusion in, rather than presumptive exclusion from, clinical drug trials.
Building on ongoing efforts by regulators, the WHO-convened Paediatric ARV Drug Optimization (PADO) and Conference on ARV Drug Optimization (CADO) groups conducted expert consultations to discuss these new principles for collecting more timely and complete data during pregnancy and breastfeeding.
These principles built on the WHO and IMPAACT network consultative processes to identify and refine optimal approaches to studying the pregnancy pharmacokinetic (PK), as well as the safety and efficacy of new HIV-related agents during pregnancy and breastfeeding.
Based on this work, a framework for accelerating inclusion of pregnant and breastfeeding women in clinical trials was developed. Implementation of this framework requires a concerted effort and urgent action by multiple stakeholders.
“This call to action puts into words the voices of women living with and at risk of HIV. Knowing that women in all their diversity will be included early in HIV drug trials will help WHO and other normative agencies make recommendations for the best and safest antiretrovirals for all pregnant and breastfeeding women and will contribute to ending AIDS as a public health threat for all populations by 2030. WHO is eager to see the principles outlined in the framework in action in the coming months,” said Meg Doherty, Director of WHO’s Global HIV, Hepatitis and STI Programmes.
“The IMPAACT network recognizes that it is time to take decisive action and accelerate the study of new antiretrovirals for prevention and treatment in pregnancy,“ said Sharon Nachman, IMPAACT Network Chair.
“We are not asking for pregnant women to be exposed to undue risks, but when we have opportunities to obtain information on a drug during pregnancy, such as when women become pregnant during trials or after safety has been ascertained, pregnant women should not be denied inclusion, especially for drugs that will be beneficial to them,“ said Mary Nyathi, Project Officer, The Ritshidze Project, South Africa.