November 2024 • PharmaTimes Magazine • 30-31
// CLINICAL TRIALS //
Born again
How new data collection methods are reshaping drug safety research during pregnancy
Drug safety during pregnancy is a sensitive topic with a convoluted history. Pregnant women have typically been excluded from clinical trials due to complex ethical and medical issues associated with the risks posed to unborn babies.
However, medical treatments for pregnant women still require robust evidence of safety and effectiveness, which can be difficult to source in the absence of trial data.
To get a sense of the complexity of this issue, it’s worth looking at its history. A stark example is the thalidomide disaster of the late 1950s and early 1960s. Thalidomide – a sedative used for morning sickness – led to horrific birth defects for hundreds of thousands of children throughout Europe.
This event shook the confidence of an entire generation of pregnant women and their healthcare providers.
More recently during the COVID-19 pandemic, vaccines were produced and tested at remarkable speed and scale.
Many pregnant women experienced heightened vaccine anxiety due to the limited safety data available for their group.
Although many women were eager to protect themselves and their babies from the virus, concerns about potential long-term effects on the foetus or newborn led to vaccine hesitation.
History lesson
Vaccine hesitation played out against a backdrop of evidence that suggested that contracting COVID-19 posed a heightened risk to pregnant women, especially in terms of the development of long COVID, a multi-systemic condition.
The history of this issue, and the recent example of COVID-19 in particular, raise a broader point. In the UK, hundreds of thousands of babies are born each year, and more than 50% of expectant mums will need to take some kind of medication when pregnant.
For those living with pre-existing conditions like type 2 diabetes, autoimmune diseases, or mental health conditions such as anxiety or depression, stopping treatment is simply not an option as it risks compromising the mother’s health, which can indirectly harm the foetus.
Even newborns and infants can be impacted by the development of something like postpartum depression.
Still, without comprehensive data around drug safety, many pregnant women feel nervous about continuing to take certain medications.
Clearly, advancements in how we test and trial drugs for pregnant women – as well as how we communicate about drug safety – continue to be critical. Such advancements are well under way.
Data dimensions
To understand the changing landscape for drug safety research during pregnancy, let’s look at how this issue has traditionally been approached.
Due to pregnant women generally being excluded from randomised controlled trials of medications, researchers must rely on other data sources, like real-world studies, to determine the safety and efficacy of medications for this group. However, such methods are often less reliable due to confounding factors and bias.
Despite this, there are extensive data registries that look at the impact of certain drugs on the pregnant mother, the developing foetus and the outcome of the pregnancy itself.
‘Advancements in how we test and trial drugs for pregnant people, as well as how we communicate about drug safety, continue to be critical’
These registries typically follow a mother and child for up to two years to ensure no complications arise, including developmental issues that may not manifest until late infancy or toddlerhood.
In the UK, pregnancy registries such as the Medicines and Pregnancy Registry, a collaboration between NHS England and the Medicines and Healthcare Regulatory Agency (MHRA), offer a better understanding of the use, benefits and risks of medicines taken during pregnancy.
Certain medical conditions, such as epilepsy or diabetes, also have dedicated registries, which are often run by health charities or research institutions.
Although registries provide deep insights into the mother-baby journey, they are costly to establish and maintain, and the results can be delayed as the data must accumulate over time. However, registries are not the only options available to researchers.
With technological advances, the medical sector now produces rich, multifaceted databases that use secondary data to understand how treatment protocols affect the mother-foetus pair.
Such databases build on previously unavailable data collection techniques like drug microdosing, organ-on-a-chip technology and earlier foetal monitoring.
Of course, new data collection techniques must continue to balance the health and safety of the mother and baby, but they do show particular promise in providing a more informed research landscape.
Analyse this
It’s not just medical research procedures that have improved for pregnant women specifically. Other data sources have played a key role.
Wearable devices and sensors, which have been thrust into the mainstream in recent years, have enhanced maternal and foetal health monitoring in a non-invasive, continuous manner.
The data collected from such devices provide a detailed breakdown on various physiological parameters such the mother’s heart rate, sleep patterns and physical activity – all crucial nuggets of information when assessing risk factors associated with certain medications or illnesses.
What’s more, recent advances in machine learning (ML) and artificial intelligence (AI) have expanded the possibility of what can be done with these data.
AI and ML promise faster, more accurate analysis of large data sets (real-world data from clinical studies, electronic health records and patient reports) to identify patterns such as the impact of specific medications on pregnancy outcomes.
Together, these technologies enable healthcare providers and pharmaceutical companies to better assess risks, tailor drug communication materials and prioritise awareness campaigns to ensure safer medication use during pregnancy.
Life-enhancing
Of course, finding reputable information about the safety of medicines, chemicals and radiological exposures during pregnancy is critical.
Fortunately, the UK Teratology Information Service has numerous databases and resources that patients and healthcare providers can consult.
The Safer Medicines in Pregnancy and Breastfeeding Consortium brings together 16 leading organisations under a common pledge to meet the information needs of pregnant and breastfeeding women and their healthcare professionals through accessible, clear and consistent advice.
There’s still some way to go in a comprehensive understanding of drug safety during pregnancy. Fully harnessing data advancements requires thoughtful communication to pregnant women (and their partners) about where and when risks associated with medications exist (or don’t exist).
With that said, resources on real-time exposures are greatly improving the rounding out of this knowledge, benefiting thousands of mothers and babies.
Dr Meg Richards is Executive Director at Panalgo. Go to panalgo.com
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