A recent study published in Trials Journal has identified several factors influencing male recruitment in a multi-site randomized behavioral clinical trial. The research sheds light on the disparities in participation rates between men and women and offers insights into strategies for improving male engagement in clinical research.
The study, which examined data from a large sample of individuals, revealed that men with specific health conditions and lifestyle factors were more likely to participate in the trial. Specifically, men who self-reported fasting glucose levels indicative of prediabetes (100-125 mg/dL) showed a greater likelihood of attending information sessions (OR = 1.69, p = 0.005). Additionally, men with higher self-efficacy regarding physical activity (OR = 1.24, p = 0.002) and those with major food allergies or dietary preferences (OR = 1.97, p = 0.03) also demonstrated increased interest in attending these sessions.
Predictors of Trial Enrollment
Further analysis revealed that Hispanic ethnicity was significantly associated with lower odds of attending baseline examinations for men (OR = 0.51, p = 0.04). In contrast, men with elevated A1c levels (5.7-6.4%), current prescriptions for fibrates (OR = 2.34, p = 0.01), fasting glucose between 100 and 125 mg/dL (OR = 1.68, p = 0.03), and triglycerides over 150 mg/dL (OR = 1.95, p = 0.003) were all positively associated with trial enrollment.
Racial Disparities in Enrollment
Notably, race emerged as a significant factor influencing trial enrollment for both sexes. Black respondents were less likely to enroll in the trial compared to White respondents (OR = 0.41, p = 0.0032 for males; OR = 0.55, p < 0.0001 for females). This finding underscores the persistent racial disparities in clinical trial participation and highlights the need for targeted interventions to address these inequities.
Implications for Clinical Trial Design
The study's findings have important implications for the design and implementation of clinical trials. Understanding the factors that influence male recruitment can help researchers develop more effective strategies for engaging men in clinical research. Tailoring recruitment efforts to address the specific needs and concerns of different demographic groups may also help to improve diversity and representation in clinical trials, ultimately leading to more generalizable and impactful research findings.
According to the study, while there was a significant difference in proportions attending an info session after being tentatively eligible (58.3% in males vs. 66.5% females; p < 0.001), no significant differences were found in proportions of males and females for baseline attendance or trial enrollment.
