BOX 3-1a Targeted Strategies to Manage Patient Recruitment
Steps for trial leadership:
Refine the patient eligibility criteria.
Understand the preparation time necessary before a trial can start.
Meet early with the IRB and legal department to try to expedite approvals.
To assess site enrollment capabilities prior to selection, review previous trial screening logs from each site.
Train investigators in strategies to maximize enrollment.
Rapidly increase then umber of clinical sites if enrollment lags.
Establish and maintain strong communication, through frequent visits and regular meetings with all sites and principal investigators.
And, at the site level:
Identify a strong leader willing to champion the trial in the institution.
Create partnerships with referring physicians and surgeons.
Consider identifying multiple principal investigators, who can reach out as a colleague to a variety of physician specialists (e.g., a cardiologist as well as a cardiac surgeon) or to different population groups (e.g., a physician who is also a community leader).
- a
Based on the presentation by Robert Michler, Surgeon-in-Chief, Professor and Chairman, and Director, Center for Heart and Vascular Care at the Montefiore Medical Center/Albert Einstein College of Medicine.