What's Happening?
The British Pharmacological Society (BPS) has issued a position statement advocating for the routine inclusion of pregnant and breastfeeding women in clinical research, where it is safe and appropriate. This call addresses the historical exclusion of these
groups from clinical trials, which has resulted in limited data on medication safety and efficacy for pregnant and breastfeeding women and their infants. The BPS highlights that over 80% of women in the UK take at least one medication during pregnancy or breastfeeding, yet the lack of evidence leaves healthcare professionals and patients without the necessary information to make informed decisions. The statement recommends the introduction of a 'pregnancy and breastfeeding investigation plan' as part of the medicines licensing framework, greater use of post-marketing and real-world data, and improved education for healthcare professionals on medication use and safety during pregnancy.
Why It's Important?
The inclusion of pregnant and breastfeeding women in clinical trials is crucial for ensuring the safety and efficacy of medications used by these groups. The current lack of data can lead to poor health outcomes for both mothers and infants, as seen during the COVID-19 vaccine trials. By addressing this gap, healthcare professionals can provide more accurate and consistent advice, reducing the risk of women refusing important medications that are safe during pregnancy. This move also reflects a broader need for investment in women's health research, which can have long-term benefits for population health. Ensuring that pregnant and breastfeeding women are included in research can lead to better treatment options and improved health outcomes for future generations.
What's Next?
The Medicines and Healthcare products Regulatory Agency (MHRA) in the UK conducted a consultation on how international guidance supporting the inclusion of pregnant and breastfeeding women in trials could be applied domestically. The conclusions from this consultation are still awaited. The BPS's recommendations, if implemented, could lead to significant changes in how clinical trials are conducted, potentially influencing global practices. Stakeholders, including healthcare professionals, researchers, and policymakers, will need to collaborate to ensure that the inclusion of these groups in clinical trials is done safely and responsibly.
