The International Council for Harmonisation (ICH) is developing a globally harmonized guideline on studying therapeutics in pregnant and breastfeeding individuals sometime this year, which should fill a much-needed void in understanding how drugs work in this population, Julia Djonova, head of advanced therapy medical products at Swissmedic, said at the DIA Europe 2025 meeting on Tuesday.
During the meeting, other health officials also described ICH’s efforts on patient engagement.
Djonova said that work on ICH E21 will continue this year and that the ICH working group developing the guidance is planning to host face-to-face soon on the topic. A final ICH E21 concept paper was endorsed by the ICH Management Committee in June 2023. Djonova said she is “optimistic” about the chances of ICH eventually signing off on the guideline.
She said there are several schools of thought on this ethically-charged issue: one school of thought says including pregnant women in medication research is too risky, while many bioethicists and researchers feel that excluding those populations from research poses other dangers. Without guidance, most treatments used during pregnancy or while breastfeeding are based on expert opinion.
Yet there is a growing awareness of the need to generate data for these populations. Djonova pointed out that most therapeutics have not been studied in these patients, including treatments for conditions that can coexist with pregnancy, such as diabetes mellitus, hypertension, and psychiatric disorders. As a consequence, there is little understanding of how treatments might affect this group.
Insufficient clinical trial data can result in either a lack of treatment options or the discontinuation of existing treatments, which may harm patients. This situation can potentially increase the risk of morbidity and mortality from both acute and chronic illnesses, as these conditions are not adequately studied in the relevant populations.
She stated that this is a “very complex topic with many regulatory, scientific, and ethical considerations.”
Patient centric guidelines
Gabriela Zenhäusern, head of stakeholder engagement at Swissmedic and ICH Assembly vice-chair, explained how ICH is also focusing its efforts on patient engagement. These include the adoption of a concept paper on an ICH E22 guideline on general considerations for patient preference studies. The paper was initiated following the ICH reflection paper to propose a guideline to advance patient-focused drug development.
This follows up on earlier efforts to promote patient engagement, including the adoption of the ICH E8(R1) guideline on general considerations for clinical trials. The guidance recommends that sponsors consult with patients or patient organizations during drug development to ensure that patients’ perspectives are captured in clinical trials. It also highlights that involving patients early in the study design is likely to increase trust in the study and improve recruitment and patient adherence. The E8(R1) guideline was adopted in October 2021.
The ICH E19 guideline is another recent effort. This document promotes a patient-centric approach to safety data collection in late-stage premarketing or postmarketing studies. It provides harmonized guidance on how to implement a targeted approach for this data collection. This guideline was adopted in September 2022.
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