A Multicenter Investigation of Factors Influencing Women\u27s Participation in Clinical Trials.

OBJECTIVE: To identify factors that influence women\u27s participation in clinical research. METHODS: 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\u27s 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. RESULTS: 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\u27s 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\u27s decision to participate. For risk to the fetus/future fertility as a barrier, pregnant women\u27s score (mean = 3.25) was significantly higher than nonpregnant women\u27s score (mean = 2.37). CONCLUSIONS: 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\u27 own language may increase their willingness to participate