The Pregnancy and Medicine Initiative has talked a lot about the data gap around pregnancy and medication. We’ve also highlighted how hard it can be to collect such information. Practical and ethical roadblocks exist which can hinder the gathering of this vital data but it’s crucial that a way around it is found.
A large-scale study in Europe is attempting to do just that. Pregnant women from the UK, Poland, Denmark, and the Netherlands were invited to sign up for a study by the Innovative Medicines Initiative (IMI) and the PROTECT consortium (Pharmacoepidemiological Research on Outcomes of Therapeutics by a European Consortium), led by the European Medicines Agency.
The study looked into whether it’s possible to collect data directly from pregnant women without the intervention of healthcare professionals, and whether this data is of high enough quality to be used for research purposes. The study was designed to find out whether women would sign themselves up to take part and if they would then choose to share sensitive information about themselves such as recreational drug use, alcohol consumption, and smoking.
Dr. Stella Blackburn, alternate coordinator of the study, says that a number of factors lie behind the gap in knowledge around pregnancy and medication. For ethical reasons, most clinical trials either exclude women who could become pregnant or require them to use effective contraception. Importantly, it tends to be only the problematic results which get reported.
“Most doctors will only report spontaneously to a pharmaceutical company when they think that there is a likelihood that the medicine has caused harm,” Dr. Blackburn says. “This is important for safety reasons but from a research perspective, it creates bias because the outcome of the pregnancy is known. It also requires someone to be suspicious that the medicine may have caused harm. This means that information on happy outcomes is much rarer. After the birth, women are unlikely to report to a company that they took their medicine and had a perfectly normal baby.”
For this reason, studies like PROTECT are vital in that they will amass data from a whole spectrum of women. Both those who go on to have good outcomes and those who run into health difficulties with their pregnancies will be included.
Results are still being analyzed from the 2,000 participants who took part but, so far, it looks as though valuable data has been gathered. One thing the study has proved is that self-enrolment seems to work.
“Although there is quite a high drop-out rate, several hundred women continued reporting throughout their pregnancy at a fraction of the cost of using traditional methods of primary data collection,” Dr. Blackburn says. “It also looks as if this enabled collection of some data that is not found in electronic health records.”
“This method could potentially be used for hard to research groups such as adolescents, people working anti-social hours, and other people who don’t see the same doctor or practice regularly.”
“Imagine having enough data to be able to start to infer causality, identify risk factors and in effect have the ability to provide women with information about which drugs are safe or less safe during pregnancy so that they, and their healthcare professionals, can make choices on the basis of reliable information.”
This study has shown that it is possible to recruit women without the intervention of healthcare professionals, while collecting good quality data. The potential is exciting. However, Dr. Blackburn says that change is still needed within the established channels of research.
It’s about patient safety
“Information about pregnancy and medication use is desperately important,” she says. “As a start, I would like to see all women who become pregnant during clinical trials followed up until the end of their pregnancy. At the moment, many women leave the trial as soon as they become pregnant and so useful data is lost.”
“I would like doctors to report any medication exposure during pregnancy before the outcome of pregnancy is known. Since most medicines do not harm the fetus, this would provide a lot of data, which could be used to reassure women. At the moment, data is more likely to be collected on the basis of harm than on no effect.”
“Finally, I would like to see a change in the pharmaceutical industry. Some companies seem to worry that collecting data could lead to problems. However, I believe that to be a short-sighted approach and that contributing to patient safety should be the goal.”
“We need to change attitudes so that data collection becomes the norm as it is in everyone’s interest to know which medicines can, or more rarely cannot, be taken during pregnancy.”
The Innovative Medicines Initiative (IMI) is a public-private partnership between the European Union and the European Federation of Pharmaceutical Industries and Associations (EFPIA). PROTECT consists of 35 partners, a mix of EFPIA companies, EU regulatory authorities, academic institutions, the International Alliance of Patients’ Organizations and small and medium companies.