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State of Clinical Research Management The Ongoing Quest to Recruit and Retain Study Volunteers

State of Clinical Research Management The Ongoing Quest to Recruit and Retain Study Volunteers. Ken Getz Tufts CSDD and CISCRP June 22, 2010. Study Conduct Risk and Inefficiency. 90% of all clinical trials delayed Since 1999: Inquiry Rates dropped from ~3% to <1%

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State of Clinical Research Management The Ongoing Quest to Recruit and Retain Study Volunteers

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  1. State of Clinical Research Management The Ongoing Quest to Recruit and Retain Study Volunteers Ken Getz Tufts CSDD and CISCRP June 22, 2010

  2. Study Conduct Risk and Inefficiency 90% of all clinical trials delayed Since 1999: Inquiry Rates dropped from ~3% to <1% Randomization rates from 75% of screened to 59% of screened Completion rates from 69% to 48% 20% of the sites are responsible for 50+% of the patients; 20% of sites fail to enroll a single patient; 30% under-enroll Approximately 7% of ALL sites actually deliver what they proposed in the feasibility assessment High levels of turnover and poor sponsor/CRO systems compatibility 20% of Sites = 55% of Patients Source: CIS, Tufts CSDD

  3. Growing Levels of Non-Compliance # of Complaints: 15 106 111 139 266 245 Complaints filed as a percent of Active INDs Note: includes all research INDs overseen by CDER, adjusted for submissions held due to agency concerns Sources: Tufts CSDD

  4. Public Confidence and Trust Sources: Research!America (JAMA, 2005); Ohmann (2004); HarrisInteractive (2002, 2004, 2007)

  5. By Extension… Study Volunteers ‘Who makes a better contribution to mankind?’ • Desperate (~29% believe only seriously-ill participate) • Risk Takers (80% believe participants are ‘gambling’ with their health) • Ambivalently respected (34% ‘Don’t Admire’ study volunteers) Source: CISCRP, 2006; N=900

  6. Primary Strategies • Assurances • Sources of Volunteers • Technology solutions • Distribution Channels

  7. Primary Strategies • Assurances • Professional certification and training • FDAA and publishing requirements • IRB accreditation • Sources of Volunteers • Extended global reach • ‘Hedging’ recruitment risk

  8. Distribution of FDA-Regulated Investigators Sources: Tufts CSDD

  9. Global Backlash Lancet 371; 2008

  10. ‘Hedging’ Recruitment Risk Mean Number of Patients per NDA Number of PIs Per Active IND * Includes all research INDs, adjusted for submissions held due to agency concerns * Does not include volunteers that participated in clinical studies not included with the NDA submission. Sources: Tufts CSDD

  11. Primary Strategies (continued) • Technology solutions • Clinical Trial Management Systems • Communication portals • Historical and predictive recruitment metrics • Integrated collaboration support systems • Online training and virtual MCMs • Distribution Channels • Traditional channels • Rapidly expanding arsenal of approaches to reach study volunteers

  12. Changing Recruitment Approaches Incidence of Volunteers from External Sources Source: CenterWatch Surveys of Investigative sites

  13. A Growing Arsenal of Recruitment Tools

  14. Blogs, Social Networking and Twitter • Rapid proliferation of Web 2.0 solutions to add to the recruitment arsenal • Opportunity to expand reach into targeted and broad communities and solicit rapid response • Crowded space • Broad ethical, regulatory and business concerns raised • Feb 3 – Market leader ‘Healogic’ exits citing a ‘difficult market’ that won’t be ready to truly embrace this solution for another 10 years

  15. Support for Long Term Success

  16. CISCRP’s Public Outreach Initiatives Public & Patients CRE Stakeholders National Outreach and Education Local Outreach and Education • PSAs – Medical Heroes • CISCRP Membership • Edutainment • Media Outreach • Original Research • House Resolution 248 • ‘Appreciation’ legislation • Post-Trial Results • Search Clinical Trials • AWARE for ALL • Educational Materials • (pre- and post-trial) • Medical Heroes packets • Speakers Bureau • Media Outreach • Science Museums • HS Science Initiatives

  17. Pre- Educating Study Volunteers • Print and video educational materials • Sites that pre-educated study volunteers • Had fewer and more effective screenings • Had patient randomization rates four times faster than sites that did not • Randomized the majority (68%) of the patients for the study

  18. Impact of ‘Medical Heroes’ Note: Pilot test involved two pain studies; 30 sites across 18 markets throughout the US Source: Eli Lilly & Company, 2007

  19. Communicating Post-Trial Results • Pilot program sponsored by Pfizer • Multiple formats • Study staff integral to entire process • Extremely positive reception from volunteers and sites • Planning national roll-out with several sponsors

  20. Rising Protocol Design Complexity Annual Growth Rate Compensation per Procedure Sources: Tufts CSDD analysis of 10,038 protocols, 2000-2006

  21. Cycle Time Metrics 69% - 75% Increase Median Days Elapsed 12% – 20% Increase Source: Tufts CSDD

  22. Conclusions

  23. Thank You Ken Getz Founder and Chairman, CISCRP kengetz@ciscrp.org www.ciscrp.org Senior Research Fellow, Tufts CSDD Kenneth.getz@tufts.edu 617-636-3487

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