Pregnant women have traditionally not been included in clinical trials. Similarly to children or prisoners, pregnant women are seen as a vulnerable population. But, is it more harmful to include pregnant women in large scale clinical trials or more harmful to exclude them from these trials? Researchers who support the participation of pregnant women in clinical studies reference occurrences where studies in pregnant women could have prevented harm such as thalidomide use in the 1960’s.
The percentage of females in clinical studies has increased to almost half of participants since the 1990’s. Despite government support and discussion since the 1970’s, clinical trials remain reluctant to include pregnant women. An analysis of registered clinical trials (2011-2012) carrying out long-term follow-up on marketed medications found that only 5% of these trials included pregnant women.
Roadblocks for Clinical Researchers and Pregnant Participants
The basis of this reluctance by clinical researchers involves multiple components including concern over fetal harm, legal liability, special regulations that govern the use of pregnant women in research, participation rates, and complicated maternal physiology during pregnancy. Investigators also have difficulty interpreting federal regulations governing research in pregnant women. These regulations require reasonable expectations of benefit and not harm to the pregnant mother and no greater than minimal risk to the fetus; however, confusing language makes interpretation difficult (ex. “minimal risk” and “prospect of direct benefit”).
Clinical investigators should address women’s fear and concerns in order to increase clinical study participation. There are many roadblocks that prevent women from starting and continuing in clinical trials. Individual factors may include fear and time constraints; community-related factors may include limited visibility of available studies and influence from family and friends; and societal factors may include federal regulations, liability, and negative incidents publicized in the media.
How Can We Safely Increased the Participation of Pregnant Women?
The National Institutes of Health (NIH) Office of Research on Women’s Health decided on three important areas of change that could improve the inclusion of pregnant women in clinical trials: classify pregnant women as medically complex and not as vulnerable; clarify regulations and make it easier for those running clinical trials to understand requirements for having pregnant women in their studies; and promote a pregnancy research agenda that focuses on important research topics such as preeclampsia, diabetes, and high blood pressure in pregnancy.
The American Congress of Obstetricians and Gynecologists (ACOG) advocates for the inclusion of pregnant women in clinical studies because of the potential to learn new information that can help women and their fetuses. Careful study planning, maternal informed consent, consideration of risks versus benefits in each participant, and any other necessary safeguards should be in place before enrolling pregnant women in clinical trials.
Next Steps for Pregnant Women Interested in Participating in a Clinical Trial
Participation in a clinical trial is a voluntary decision for a pregnant woman. There may be cases where a pregnant woman or her fetus is faced with a serious medical condition with few options other than wait-and-see or participation in a clinical trial. Even in these circumstances, women should not feel pressure to participate in a clinical trial based on an emotional decision. Before participating in a clinical trial, women should be informed of any risks or benefits, know their options, and should fully understand what involvement in a clinical trial means.
Clinical trials are governed by significant oversight. This oversight is intended to protect human participants. Clinical trials generally have a regulatory and ethical committee that oversees research activity and ensures that regulations are followed. Clinical trials are also required to obtain informed consent from participants, maintain and monitor safety data, and provide specialized education for researchers on how to conduct human trials.