Background:
Randomized controlled trials (RCTs) provide the strongest evidence of efficacy for medical interventions. However, a major criticism about the external validity of RCT results is the under-representation of women. Previous studies on cardiovascular disease have found female representation in secondary prevention RCTs to be less than 1/3. This underrepresentation of women can lead to suboptimal conclusions regarding their care.  Currently, limited data are available regarding successful recruitment strategies for women in RCTs. It is important to understand the barriers to recruiting women in secondary prevention RCTs and to identify strategies to overcome those barriers. 

 Objective: 
To determine whether an association exists between the gender of the investigative site personnel involved in the consent process and the sex distribution of participants in NAVIGATE ESUS.

 Methods:
We plan to analyse data from 23 Canadian Navigate ESUS sites that recruited 573 participants to determine the proportion of female subjects recruited, and whether a discrepancy exists according to the gender of the primary study personnel involved in the consenting process.

Conclusion: 
A major criticism of the external validity of RCT results is the discrepancy of female to male representation. Through investigating the discrepancies and barriers to equal sex distribution in clinical research our study will help identify factors to promote female inclusion in RCTs and pave way to future studies looking at strategies to overcome these barriers.

Discrepancy of female enrolment in stroke secondary prevention studies: relationship between investigative site personnel sex and selection of participants