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Optimizing start up activities to decrease your study timeline - Part 3


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This presentation is part 3 in a 3 part series of presentations on optimizing the clinical start up activities.

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Optimizing start up activities to decrease your study timeline - Part 3

  1. 1. Optimizing Start-up Activities to Decrease Your Study Timeline Part 3: Prequalification
  2. 2. Areas of Focus • Part 3 - Prequalification
  3. 3. Decision-making process • Consider these personal examples: – Have you ever hired based on a CV and phone interview? – Have you bought a car without taking it for a test drive? – Have you bought a house from the information on without an inspection? • Why select sites without a test drive?
  4. 4. Prequalification Agenda • Meet the Enrollment Drivers • Tour the Facilities • Consider the “Not So Hidden” Agenda • Trip Report
  5. 5. Meet with the Enrollment Drivers • What should you expect? – Typically 1 FTE = 4.3 studies1 – Study Coordinators report that one to six studies is manageable • Over 50% of the respondents were working on 7 or more studies2 – How long have they been at the site? • Staff turnover = lower patient adherence3 • If you can’t identify the Enrollment Driver, you may have identified a potential problem. 1- Neuer A. 2002. The rising tide of CRC workload and turnover. The CenterWatch Monthly; 9(8):1-5. 2 - Duane, C. 2007. Study Coordinators’ Perceptions of their work experiences. Monitor: 39-42. 3 – Harris Interactive. 2004. “Most Physicians Do Not Participate in Clinical Trials Because of Lack of Opportunity, Time, Personnel Support and Resources. Health Care News 4(9):1-8.
  6. 6. Meet with the Enrollment Drivers • The Study Coordinator and Appointment Scheduler – What is their time allocation to research? – 87% of sites surveyed were devoting 50% or less to research. 4 • What are their other commitments (research and clinical)? 4 – Graziosi A. 2010. Investigator Site Survey, Applied Clinical Trials Research Utilization 5-25% 67% 26-50% 20% 51-75% 8% >75% 5%
  7. 7. Tour the Facilities • Confirm the expected – Device Storage, study binders, sample freezers, technology, etc. • Check for the unexpected – Take the “Patient Tour” • Ask to experience the patient visits per the protocol • Are they located close to support services (imaging, labs, etc.) This provides a patient-centric perspective and useful data on the site and your protocol
  8. 8. The “Not So Hidden” Agenda • Get there early – How does the site welcome you? – How are patients treated? • Are they given attention? Viewed as a burden? – How does scheduling/follow-up occur? • Assess the intangibles of the facilities – Are the research coordinators at the facility? • How are potential patients identified? • How are they approached about the study? • How accessible is the Investigator for Coordinator or Monitor questions? – Is there designated monitoring space? – How will the source documents be provided for monitoring? • Confirm the data – Enrollment rate / Query rate for the indication
  9. 9. Trip Report • Ensure congruency between the study requirements and the prequalification visit outcomes • Discuss any red flags identified and their potential impact • Add sites with longer lead times or short-term resource constraints to the “contingency pool”
  10. 10. Prequalification Costs • Direct costs • Staff*= $960 • Travel**= $1500 • Total= $2460/visit • * - Staff costs assumes a CRA II ($60/hr salary and benefits) utilized for a one day visit and one day for administrative preparation (agenda / document preparation) and trip report completion. • **- Travel includes a 1 day visit with an overnight accommodation, meals, rental car, mileage and airport parking • Site Initiation costs= $30,0005 • By reducing the number of non-performing sites by 5%: 5- Li, G. 2010. Planning the Right Number of Investigative Sites for a Clinical Trial. Monitor: 54-58.
  11. 11. Optimizing Start-up Activities to Decrease Your Study Timeline For more information or to schedule a discussion, contact us at: