The document discusses the importance of early clinical recruitment planning for drug development programs. It notes that delays in recruitment can significantly increase costs and impact revenue opportunities due to later market entry. Early planning allows consideration of factors like disease characteristics, enrollment population size, competition, and protocol challenges that influence feasibility. Comprehensive recruitment programs costing 1-12% of delay costs can help avoid delays and ensure timely trial completion and drug approval.

1. Clinical Recruitment Planning Strategies: When is the Right Time to Plan, Implement, and Spend? Manley R. Finch, PhD(c), MPH Vice President, Clinical Research SleepMed, Inc.

5. Why Rapid Enrollment is Not Only Important – It is Critical

6. File IND at FDA File NDA at FDA Discovery/ Preclinical Testing Phase I Phase II Phase III FDA Source: PhRMA http://www.phrma.org/publications/publications//2002-10-21.601.pdf Clinical Trials Phase IV Drug Development Process Years 6.5 Test Population Laboratory and animal studies Purpose Assess safety, biological activity and formulations Success Rate 5,000 compounds evaluated 1.5 2 3.5 20 to 100 healthy volunteers 100 to 500 patient volunteers 1,000 to 5,000 patient volunteers Determine safety and dosage Evaluate effectiveness look for side effects Confirm effectiveness, monitor adverse reactions from long-term use 13 enter trials 1.5 Post market testing required by FDA Review process & approval 1 approved

20. $ THE RACE IS ON $

22. How to Know When to Plan

39. When to Plan? As soon as you begin to write the development program

41. Must not burn recruitment budget Must be Band-aiding again

42. Thank You Questions?