Do pregnant women and people have opportunities to participate in clinical trials?

An exploratory survey of NIHR HTA-funded trialists

Rebekah Burrow is leading this research.

While I was pregnant I struggled to find information about how safe the medicine I would normally take was, for me and my growing baby. I also struggled to find information about whether the medicine would work less well, or differently, while I was pregnant. I talked to Professor Mike Clarke who developed the idea for this piece of research with me.

What is the problem?

Pregnant women and people are included in clinical trials when the trial is testing something related to the pregnancy, or birth, that might help the mother, birthing parent, or baby. Clinical trials are a type of research. Clinical trials need to study people (participants) who are representative of real patients. When they do, we can work out how safe and effective the interventions (maybe a medicine or a test) being trialed are, for real patients.

Pregnant people are not allowed to take part in most clinical trials. For example, they are often excluded from trials testing a drug to manage depression, a vaccine to prevent COVID, or a test for urinary tract infections.

Many pregnant people have common medical conditions. Without evidence from clinical trials, doctors and midwives often don’t know if the care they would normally give is safe. They often don’t know if the care they would normally give works as well when someone is pregnant.

Sometimes, this means doctors and midwifes do not give normal care that is safe and effective. Without this care, babies are more likely to be born prematurely, or die. Women and pregnant people are more likely to die. There are lots of reasons why pregnant people are not included all clinical trials, like knowing something tested in the trial is dangerous for a growing baby. But some clinical trials have proved it is possible to include pregnant people, even in tricky situations. Many pregnant people would like to be given the choice of whether or not to take part in clinical trials. They say they want to help other people, or they hope it will provide better care, or some other benefit for them or their baby.

Public organisations in the UK who spend money on research tell researchers to make their research inclusive of "under-served groups". Women, women of child-bearing age, and pregnant women and people are under-served groups. Including under-served groups is an ethical principal that clinical trialists (researchers who carry out clinical trials) promise to uphold.

One organisation in the UK, the National Institute for Health and Care Research, spends money on lots of clinical trials. These trials are the sort of trials that doctors rely on to know how to treat patients. We do not know much about how many of these clinical trials include pregnant people. We know they are the most likely clinical trials to include people who are pregnant.

What research did we do?

This research is an survey. A survey is a method used to collect information by asking a group of people questions. This online survey collects information from researchers who carry out clinical trials (clinical trialists) who were given money by the National Institute for Health and Care Research. The survey asks the clinical trialists about:

• whether their clinical trials include pregnant people
• why clinical trialists included or excluded pregnant people
• how pregnant people are included, or excluded

What did we find out?

We found 120 clinical trials being carried out. 88 of these trials could have included pregnant people. Researchers working on 81 of these trials answered our survey questions. 34 of these 81 trials excluded pregnant people. 40 of the 81 trials included pregnant people in at least some of the trial. For 7 trials it was not clear if pregnant people were allowed to take part, or not. When clinical trialists excluded pregnant people, it was most often to keep them or their growing baby safe. However, sometimes clinical trialists wanted to include people who were pregnant, and in spite of the fact that it was safe, were not able to do so. 8 trials described doing something on purpose to include pregnant people.

What does this mean?

Of the 120 clinical trials most did not include pregnant people. Most trials that did include pregnant people did not do anything to try to help them participate in the trial. Other trials are even less likely to include pregnant people.

What are we doing about it?

We have:

• told the National Institute for Health and Care Research about our results
• published our work for other researchers to read
• started the next piece of research to systematically collect what work has already been done

We are asking for funding to carry out more research that will support clinical trialists to include pregnant people in their clinical trials.

Patient and Public Involvement

We talked to women with experience of pregnancy. We asked about their experiences while pregnant, including their access to treatments, information about treatments, and participation in research. We also asked about their opinions of, and interest in, research to increase inclusion in research during pregnancy. We asked one contributor to review our results and the way that we had reported them.