Clinical Research with Pregnant Women: Investigator Insights on Success

Abstract

The lack of clinical research in pregnancy negatively impacts the ability to provide therapeutic treatments and preventions to pregnant women. This study explores the experiences of investigators who have successfully conducted clinical research in pregnancy to identify factors that facilitate success. Semi-structured, in-depth interviews were conducted with seven biomedical investigators affiliated with the University of Washington. A content analysis was conducted to extract concepts and themes identified by the investigator participants. Four major themes were identified from content analysis: investigator motivations for doing research in pregnancy; financial, scientific, design and legal considerations; relationships; and qualities of a successful investigator. These categories of themes were then analyzed to identify eight factors that enhance the likelihood of successful research in pregnancy. This pilot study identified factors that contribute to successful clinical research with pregnant women. Future research will expand the analysis of investigators’ experiences and add examination of the experiences of IRB-affiliated individuals and ethics consultants who have distinct insights into the ethical and legal dimensions of research in pregnancy.