Patient Enrollment for Major Depressive Disorder

April 27, 2015

Project Background

Clariness recently assisted a sponsor with recruitment of patients for Phase II-III studies involving a promising treatment for major depressive disorder. As a large, global program, the scope involved five continents and 12 countries. Initially, Clariness was asked to manage patient enrollment in every country outside of North America, where recruitment was contracted to a domestic provider.

Challenges

Protocol requirements posed several recruitment challenges. Inclusion criteria specified non-responders to prospective anti-depressant therapy. The screening and qualification process needed to objectively determine non-response was lengthy and complex. Due to an expected high screen failure rate, a surplus of pre-qualified referrals were necessary.

Clariness Approach

As a first step, the Clariness team recommended a mix of online recruitment tactics that began with outreach to patients who had already signed up in ClinLife® (Clariness’ proprietary patient recruitment technology that operates in more than 40 countries). Other targeted tactics included:
• Banner and text ads were placed on websites based on demographics of trial population and caregivers
• Ads were shown within a specific radius around clinical trial centers
• Ads were started/stopped for a site based on referral volume
• Local language ads and ClinLife websites were customized for each country
The nature of indication also required a high level of patient support from Clariness’  enrollment specialists who diligently contacted potential patients and provided follow-up communication through the pre-qualification process. An in-depth understanding of patient motivation as well as their ability to address patient concerns about study participation overcame a major hurdle to patient enrollment success.
Five months into recruitment, Clariness also took over US recruitment efforts, in addition to the 11 other countries already part of the project, after traditional recruitment tactics employed by the US-based vendor generated few high cost, low-yield results.

Results

In the end, Clariness’ recruitment approach definitively outperformed expectations by reducing timelines, boosting patient enrollment and using cost-effective tactics:
• Enrollment timelines were shortened by seven months.
• Actual number of sites-weeks was approximately half of planned.
• Recruitment efforts generated twice as many scheduled patients than planned.
• The advertising cost per response was two times less than planned.
• Even with accelerated recruitment efforts and a shortened timeline in the US, total recruitment expenses came in under budget.

Katherine CloningerPatient Enrollment for Major Depressive Disorder