Personal physicians as study investigators: impact on patients' willingness to participate in clinical trials.

Background: We asked whether patients are more willing to participate (WTP) in a cardiovascular drug trial if their personal rather than an unfamiliar physician were engaged as the study investigator.

Methods: We approached 1440 randomly selected patients from 13 Maryland-based outpatient cardiology and general medicine clinics to complete an 86-item self-administered questionnaire. We then asked respondents their WTP if their personal rather than an unfamiliar physician were the study investigator, as well as their trust in physicians and quality of their health care experiences.

Results: Of 1132 patients eligible, 789 (70%) patients responded and 666 had complete data. Patients were "very likely/likely" to participate in the study 56% of the time if conducted by their personal compared to only 36% if by an unfamiliar physician (p<0.0001). After adjusting for age, race, gender, and socioeconomic and health status, only the presence of a family member or friend in health care was positively associated with "very likely/likely" WTP with unfamiliar physician (OR, 95% CI=1.42, 0.99-2.03). If by a personal physician, however, trust in physician (1.57, 1.16-2.11, per 1/5 unit increase), rating of health care quality (1.18, 1.06-1.31 per 1/10 unit increase), and having a family member or friend in health care (1.57, 1.16-2.11) were important predictors of WTP.

Conclusion: Patients are much more likely to enroll in a clinical trial if their personal physician is engaged as a study investigator, which could relate to the importance of communication, trust, and familiarity with the health care system.