The scope of work was to provide patient recruitment support services for a European epilepsy study held back by recruitment delays.

The Challenge

Lack of motivation: Sites were not motivated to meet enrolment targets, and after 23 months of active enrolment, 37% of active sites had not enrolled any patients. The rest of the sites had enrolled only 378 patients, with an average recruitment of 16.4 patients per month.

13

Months of Clintec Recruitment Support
383.%

Average patients per month
100+%

Increase to the previous average of 16.4%

The Approach

The following initiatives were undertaken to enhance recruitment at the sites.

Our Site Support Executives (SSEs) completed a site assessment questionnaire to understand the unique challenges the sites encountered in recruitment, and the strategies that had worked in the past.
A site-specific enrolment plan was developed for all sites based on the responses to the site assessment questionnaire.
The SSEs guided the sites on effective utilization of the patient recruitment tools including advertising budgets, screening tools and referral networks.
The SSEs had regular interactions with the sites through weekly calls to assess the outcome of the recruitment plan and keep the sites focussed.
Recognising the value of relationship with investigators, Clintec SSEs regularly interacted with them. Laminated inclusion / exclusion criteria cards were provided to keep the study “at the top of the mind” of both the investigators and the site staff.
The SSEs through constant guidance, support, and appreciation ensured the site staff were motivated.

The Outcome

Over 13 months of recruitment support, we recruited an additional 498 subjects to the study at an average of 38.3 patients per month – more than twice the previous average of 16.4 patients per month. The following graph illustrates the significant difference in-patient screening time before and after our appointment.

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