Best Practices in Clinical Study Recruitment
•Transferir como PPTX, PDF•
3 gostaram•1,855 visualizações
By Nariman Nasser, Director of Participant Recruitment Service, CTSI, UCSF
Recomendados
Recomendados
Mais conteúdo relacionado
Mais procurados
Mais procurados (20)
Semelhante a Best Practices in Clinical Study Recruitment
Semelhante a Best Practices in Clinical Study Recruitment (20)
Mais de CTSI at UCSF
Mais de CTSI at UCSF (20)
Último
Último (20)
Best Practices in Clinical Study Recruitment
- 1. Best Practices in Clinical Study Recruitment Nariman A. Nasser, Director Participant Recruitment Service
- 2. AGENDA Recruitment Practices Retention Practices UCSF Participant Recruitment Service
- 4. Performing Initial Analyses Study Design Site-specific protocols for study-specific and SOC procedures Placebo arms, excessive inclusion/exclusion criteria Site-specific Staff resources Location(s): accessibility, interoperability, features / disadvantages Competing Trials
- 5. Planning & Budgeting Screen Failure Rate Budget for the unexpected Design revisions Increased production & shipping costs over time Protocol revisions impacting recruiting methods/materials
- 7. Implementing the Plan Staged approach Communication Plan Sponsor/Site Staff Multiple Primary contacts simultaneous Secondary contacts advertising efforts Plan on changing Identify screening your plan – analyze appointment relatively often schedule workflow, tools and conflicts
- 8. Ensuring High-Quality Participants Start by casting a wide net Think about a wide number of things or people when choosing the thing or person you want* Don’t skip the prescreening step Ask the right questions at the right stage of the recruitment process *Idioms by The Free Dictionary
- 9. Monitoring Progress Set realistic expectations up front Identify benchmarks for success/failure Simple tracking tools go a long way Receiving logs & reports is not enough – they have to mean something and be actionable
- 10. Managing Enrollment Underperformance Create competition among sites, coordinators and investigators to increase momentum and foster enthusiasm Communicate underperformance before it becomes insurmountable Be supportive in providing possible resources and solutions Ensure nonperformance consequences are communicated prior to starting recruitment Have a backup plan/resource
- 12. Ensuring Participants Are Well-Informed Public opinion drives policy Passionate advocates are essential “If you have more than 50 percent of patients saying their chances are better than average of avoiding some harm or obtaining some benefit, they are being unrealistically optimistic because you can’t say that most people are above average.” Parker-Hope, Patients with Unrealistic Expectations, The New York Times, March 7 2011
- 13. Understanding Participant Needs Work/family obligations Travel constraints Financial incentives Desire for information/sense of community Expectations of coordinated care Lack of insurance/comparison to SOC
- 14. Keeping Communication Open Press releases Local media Patient newsletters Direct patient/study staff communication via email or telephone Post-study satisfaction surveys, newsletters, study drug updates
- 16. Create a centralized service to facilitate the enrollment of research participants into UCSF clinical studies Assume a large part of the burden of recruitment efforts Provide expertise in recruitment materials development Ensure materials meet regulatory guidelines and requirements Offer an economy of scale for many recruitment activities Use established vendor relationships Increase the volume of high quality volunteers Facilitate a wider catchment and more robust networks
- 17. Recruitment Analysis and Planning Robust recruitment plan Analysis of recruitment landscape Protocol complexities, procedures, SOC Competing studies Geographic/demographic population Marketing & Outreach methodologies Suggested strategies Timelines Budgets for suggested strategies
- 18. Cohort ID and Direct Mail Identify cohorts from inpatient medical records (UCare and ThREDS) ICD-9 codes Demographics CHR modification Coordinate data extract services from ARS Print and mail direct mail letters to cohort
- 19. Other Resources Research Participant Registry Recruitment Materials Toolkit
- 20. Future Services/Resources Recruitment Plan Implementation Centralized call center, text messaging, online screeners Marketing & outreach Referral networks Searchable database of actively recruiting studies – matching Real-time recruitment from EMR
- 21. THANK YOU