Overview of the Recruitment and Retention Landscape:

Transcription

1 Overview of the Recruitment and Retention Landscape: What have we learned and What are we missing? Ken Getz April 30, 2010

2 Meeting Agenda Situation Summary Primary Strategies and Their Impact Education and Outreach Missed Opportunity Conclusions

3 Situation Summary Since 1999, recruitment and retention have worsened: Inquiry Rates dropped from ~3% to <1% Randomization rates from 75% of screened to 59% of screened Completion rates from 69% to 48% Highly variable site performance: On average about 20% of the sites are responsible for 50+% of the patients; 20% of sites fail to enroll a single patient; 30% under-enroll Ex-US/WE sites have been significantly more productive and cost effective; but add substantial logistical complexity Eroded levels of public and patient trust Rising development delays and high study staff turnover Source: TuftsCSDD; CenterWatch

4 Public Confidence and Trust General Public Attitudes 70%-83% of Americans believe clinical research is very important or essential to advancing public health 65% of Europeans believe that clinical research plays an important role in advancing public health Perceptions of Clinical Research Professionals 42% of Americans and 36% of Europeans distrust biopharmaceutical companies 31% of Americans believe the FDA is effective at ensuring public/patient safety 25% of Americans and 17% of Europeans believe that PIs and study staff are primarily motivated by greed Sources: Research!America (JAMA, 2005); Ohmann (2004); HarrisInteractive (2002, 2004, 2007)

5 By Extension Study Volunteers Desperate (~29% believe only seriously-ill participate) Who makes a better contribution to mankind? 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 Sources of Volunteers Assurances Technology solutions Distribution Channels

7 Primary Strategies Sources of Volunteers Extended global reach Partnerships with health associations Hedging Assurances Professional certification and additional training IRB accreditation ClinicalTrials.Gov branded trial and results listings

8 Distribution of FDA-Regulated Investigators Percent of Total 1572s Filed US-Based Western Europe Rest of World 100% 75% 5% 9% 12% 13% 9% 10% 19% 11% 25% 13% 29% 14% 50% 25% 86% 80% 77% 70% 62% 57% 0% Sources: Tufts CSDD

9 Distribution of Active Clinical Trials Phase I Phase II Phase III Phase IV N. America 76% 64% 38% 47% WEurope 14% 22% 32% 31% EEurope 5% 6% 10% 7% Asia 4% 5% 11% 11% SC America 1% 3% 9% 4% Source: Opperheimer 2008 Analysis of Clinicaltrials.Gov,

10 Average Patient Enrollment Duration Enrollment duration (months) Number of patients Number of patients/ month Asia East Europe Western Europe Australia South America USA n Sample: Phase II and III CNS, Diabetes and CV multi-center clinical studies; in one region only; comparably sized Source: Tufts CSDD Analysis of Selected Trials on Clinicaltrials.Gov, 2006

11 Comparing Cost Cost per Patient as a Percentage of that in US/EU 76% 71% 50% 41% SCAmerica Eeu India China Source: Goldman Sachs Research, 2009

12 Global Backlash Lancet 371; 2008

13 Number Patients Enrolled Patient Recruitment Risk % of Sites = 55% of Patients On average about 20% of the sites are responsible for 50+% of the patients Pfizer reported that 80% of patients from 26% of sites 20% of sites fail to enroll a single patient; 30% under-enroll Pfizer reported that 37% of oncology investigators failed to enroll a single patient at $25,000 to recruit each site Approximately 7% of ALL sites actually deliver what they proposed in the feasibility assessment Site Number Source: CIS

14 Hedging and its Unintended Consequences Number of PIs Per Active IND ,582 Mean Number of Patients per NDA 5, , ,452 2,505 2, * 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

15 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 Clinical trial listings and results registries Study-specific and portfolio-based web sites Social Networking Twitter and instant communications

16 Changing Recruitment Approaches Incidence of Volunteers from External Sources Community-Based AHC 41% 51% 38% 58% 41% 29% Source: CenterWatch Surveys of Investigative sites

17 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 Marginal Impact of distribution strategies without public and patient education and a support network in place

18 Support for Long Term Success SUSTAIN (Community of Participants and Ambassadors) RECRUIT & RETAIN ENHANCE (General Education and Awareness) ENABLE (Support Network and Tools)

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

20 Medical Heroes Impacts Public Perception Enrollment Rate in 12 Markets with Mass Media Patient Recruitment Ads Only Enrollment Rate in 6 Markets with Mass Media Recruitment Ads in Conjunction with Everyday Heroes Campaign Improvement in Enrollment Rates from Concurrent Ad and Outreach Campaign Use WAVE Patients/Month 4.0 Patients/Month 38% WAVE Patient/Month 9.6 Patients/Month 140% Note: Pilot test involved two pain studies; 30 sites across 18 markets throughout the US Source: Eli Lilly & Company, 2007

21 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 How well do you feel you understand the results of your clinical trial? Pre - Pilot Post - Pilot Very Well/ Somewhat Well 16% 92% Not Very Well/ Not at All Well 84% 8%

22 Annual Growth Rate Missed Opportunity: Rising Protocol Design Complexity 6.5% 8.7% 10.5% 12.1% Compensation per Procedure Number of Unique Procedures Frequency of Procedures Execution Burden Number of Eligibility Criteria -7.9% Sources: Tufts CSDD analysis of 10,038 protocols,

23 Impact of Tougher Protocols US-based Pivotal Trial Protocols Executed (Lower Complexity) (Higher Complexity) Rising number of amendments Number of CRF pages increases from 55 to 180 pages Controlling for treatment duration, cycle times increased substantially 12% longer protocol readiness to FPFV 70% longer from protocol readiness to data lock Enrollment rates were significantly worse on more complex and burdensome protocols Source: Tufts CSDD

24 Conclusions SUSTAIN (Community of Participants and Ambassadors) RECRUIT & RETAIN ENHANCE (General Education and Awareness) ENABLE (Support Network and Tools)

25 Thank You Ken Getz Founder and Chairman, CISCRP Senior Research Fellow, Tufts CSDD