Problem:
Small biotech firm had projected to enrol 180 patients in 6 months but only half the number had been randomized by 4 months. Extension of the recruitment deadline was not possible as it would impact several important milestones downstream including a presentation of data at a meeting in 6 months to a panel of investors and venture capitalists who would decide on continuation of venture financing.

Approach:
Organized a “deep dive” brainstorming session with all internal study stakeholders and the client to determine root cause and next steps. Separately, organized a meeting with all study principal investigators to get their feedback on recruitment challenges.

Recommendations:
The results of these meetings enabled project manager to strengthen the Patient Recruitment Plan and outline a set of key deliverables and timelines as follows:

• Mass re-initiation of “stalled” sites and site closure thereafter if no enrolment within 30-days
• Identification / initiation of additional sites throughout remaining enrolment period
• Visits by client representative and project manager to selected sites where recruitment was still lagging after 30 days.
• Enhanced site communications regarding study goals:
  
  1. Study Coordinator teleconferences where laggard sites where able to discuss success strategies with vanguard sites
  2. Frequent fax-bursts and newsletters
  3. Weekly calls from team members to trouble-shoot enrolment challenges
  4. Mid-study investigator rejuvenation meeting
• Revised Investigator Contracts to increase frequency of payments and offer recruitment bonuses based on patient randomization milestones.
• Worked closely with DSMB to make necessary protocol amendment and CRF changes, to simplify inclusion/ exclusion criteria and to ultimately enhance patient safety and site “buy-in”
• Recruitment professional worked with each site to craft a targeted advertising campaign.
• Tracked enrolment on a daily basis and provided site-by-site updates to monitors to discuss with their sites during weekly sites calls.

Results:
Recruitment deadline was only exceeded by two weeks and the study ultimately over enrolled by 10 patients which proved very helpful later in the trial when patient drop-out rate was found to be slightly higher than projected thereby preserving the power of the study.

 

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