INVESTIGATOR TRAINING PRESENTATION

1
Benefits of Collaboration Clinical Trial
Recruitment Ernie Stefanelli, Project Manager
Oncology
September 30, 2006
2
Optimizing Patient Recruitment

• Choose appropriate sites
• Develop an effective patient recruitment plan
• Track patient enrollment
• Resolve problems involving slow recruitment

3
Site Selection

• Choose sites with experience
• Geographically dispersed sites
• Vary the type of site used (Community vs.
  Academic)
• Ensure sites see the appropriate patient
  population
• Competing studies
• Patient enrollment expectations

4
How to Recruit Patients

• Develop an effective recruitment plan
• How many patients can a site recruit and follow?
• What are the sources of these patients?
• Patient Databases
• Referrals
• Use of Screening Tools
• Worksheets
• Chart Flags
• Advertise

5
Examples of Advertisements

• Newspaper ads
• Radio/TV Commercials
• Pre-scripted/approved material
• Internet
• Clinicatrials.gov
• Support Groups
• Hospital Website
• Other options
• Mailings
• Flyers

6
Tracking Patient Recruitment

• Pre Screening and Screening Logs
• Review results on a regular basis
• Are potential patients being seen?
• Reasons for patients who fail screening
• Evaluation of screen failure rate
• Evaluate entry criteria for rigidity

7
Sample Screening Log
8
Resolve Patient Recruitment Issues

• Are there trends in screen failures?
• Protocol Amendments
• Are sites not seeing patients?
• Close unproductive sites/Add new sites
• Discuss new strategies with investigators
• Advertise
• New patient sources
• Other Motivational Techniques
• Newsletters to sites
• Study Teleconferences

9

• Thank You