A novel clinical trial recruitment strategy for women's cancer

Abstract

Objective: To address a deficiency in clinical trial and research enrollment in gynecologic cancer studies, we launched a paper based patient research registry. To improve registry enrollment, we transitioned to an online registry and trial matching mechanism to aid women in accessing open studies.

Methods: Utilizing a validated verification platform, we designed a web-based registry and trial matching mechanism for women over age 18. Participants completed a questionnaire to provide information for trial matching. A focus group of registry participants was held 9 months after the start of the study to evaluate barriers to participation.

Results: A total of 322 women were enrolled in the online registry over a 14 month period which was a 4.3 fold increase over the paper-based registry (p<0.0001). Two hundred and sixty three (82%) women were matched to at least one study. Fifteen percent (39/263) of those eligible for studies went on to enroll. The online enrollment rate to studies was not different from that observed in the paper-based registry (26/172, p=0.934), however, the web-based registry linked participants to subsequent studies 27% more rapidly (68 (+/-98) days vs. 93 (+/-81) days for the paper-based registry, p=0.017). Focus group participants identified areas for improvement.

Conclusion: Web-based patient driven registry provides dramatic improvement in the number of participants enrolled and the time to trial linkage compared to a paper based registry at a single institution. Further studies of barriers to research participation are necessary to improve on this model.

Keywords: Clinical trial; Enrollment; Registry.