A Multicenter Investigation of Factors Influencing Women's Participation in Clinical Trials

To identify factors that influence women's participation in clinical research.

We administered a survey in outpatient and inpatient populations of Obstetrics and Gynecology facilities of six institutions located in four states. The survey included questions regarding any of the participant's past experiences in clinical research and the factors that would influence their participation in clinical research. Analyses included descriptive statistics and a Principal Component Analysis.

The analysis included 3,773 respondents; 2,477 (68.1%) were pregnant. The majority of participants were Caucasian (1,453, 40.2%), followed by Hispanic (933, 25.8%), African American/black (744, 20.6%), other minorities (270, 7.5%), and multiracial (212, 5.9%). Ten potential motivating factors and 10 potential barriers were assessed. The greatest motivating factor was "how well research is explained" (mean = 2.87) while "risk of unknown side effects" was the greatest barrier (mean = 3.07) for women's participation in clinical trials. Among six helpful resources assessed, "material in my own language" was scored as the highest (mean = 2.8) in facilitating women's decision to participate. For "risk to the fetus/future fertility" as a barrier, pregnant women's score (mean = 3.25) was significantly higher than nonpregnant women's score (mean = 2.37).

Overall, the risk of unknown side effects discourages women in general, and the risk to the fetus/future fertility discourages pregnant women the most from participating in clinical trials. However, explaining a study well and providing written material in the patients' own language may increase their willingness to participate.