Safe and Ethical Inclusion of Pregnant and Breastfeeding Women in Clinical Trials: a New ICH Guideline and a WHO Task Force
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) has released a draft guideline, ICH E21 (available here), focusing on the inclusion of pregnant and breastfeeding women in clinical trials. At the same time the WHO is establishing a Task Force to improve this its activity in this area. These initiatives both aim to address a longstanding gap in clinical research involving these populations.
Historical exclusion
Historically, pregnant and breastfeeding women have been excluded from clinical trials due to concerns about potential risks to the foetus and breastfed infant. An analysis by the Global Observatory on Health Research and Development found that only 4% of clinical trials recorded in the International Clinical Trials Registry Platform (ICTRP) over the past decade included pregnant women. This leaves many without treatment options or relying on off-label use of medicines, as well as significant gaps in evidence on the safety and efficacy of medicines and vaccines for these populations.
Key Aspects of the Draft Guideline
The new ICH E21 guideline seeks to provide a globally accepted framework and best practices for the inclusion and retention of pregnant and breastfeeding women in clinical trials. The objective is to generate robust data that can inform safer and more effective treatment options for these populations.
- Risk-Benefit Evaluation: The guideline emphasises the importance of evaluating the risks and benefits of including pregnant and breastfeeding women in clinical trials. This includes considering potential impacts on the foetus and the breastfed infant.
- Informed Consent: Ensuring that participants provide informed consent is crucial. The guideline outlines the need for clear communication about the potential risks and benefits, enabling participants to make well-informed decisions.
- Protocol Design: Practical guidance is provided for designing clinical trial protocols that include pregnant and breastfeeding women. This includes considerations for data collection, safety monitoring, and follow-up for both mother and child.
- Regulatory Compliance: The guideline aligns with other ICH and pharmacovigilance guidelines to ensure comprehensive regulatory compliance. This includes obtaining necessary approvals and adhering to the usual ethical standards.
WHO Initiative for Ethical Inclusion
The World Health Organisation (WHO) is also focusing on this issue. It has established a new global Task Force to address it, aiming to improve the ethical inclusion of pregnant and breastfeeding women in clinical trials over the next five years. The Task Force is intended to serve as a collaborative platform to align WHO approaches in promoting safe and ethical inclusion of pregnant women, reduce duplication, and foster partnerships with international stakeholders to overcome regulatory, ethical, and operational barriers.
Implications for Clinical Research
The inclusion of pregnant and breastfeeding women in clinical trials is expected to enhance the understanding of how medicinal products affect these populations. If successful, this will lead to more informed treatment decisions, improved patient outcomes, and the development of safer therapeutic options.
For pharmaceutical companies, the new guideline presents an opportunity to expand their research and development efforts to include these underrepresented populations. By doing so, they can contribute to a more inclusive and comprehensive body of clinical evidence, while remaining confident that they are acting responsibly.
Opportunity to provide input
The draft ICH E21 guideline marks a pivotal moment in clinical research, addressing the critical need for data on the safety and efficacy of medicinal products for pregnant and breastfeeding women. As this guideline moves through the consultation process, there is an opportunity for stakeholders to engage and provide feedback to ensure its successful implementation.
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