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.

From: 3, Recruitment Challenges in Clinical Trials for Different Diseases and Conditions

Cover of Public Engagement and Clinical Trials
Public Engagement and Clinical Trials: New Models and Disruptive Technologies: Workshop Summary.
Institute of Medicine (US).
Washington (DC): National Academies Press (US); 2012.
Copyright © 2012, National Academy of Sciences.

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