State of Clinical Research Management
The Ongoing Quest to Recruit and Retain Study Volunteers
Ken Getz
Tufts CSDD and CISCRP
June 22, 2010
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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
20% of Sites = 55% of Patients
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
Source: CIS, Tufts CSDD
Growing Levels of Non-Compliance
Complaints filed as a percent of
Active INDs
# of Complaints:
15
106
111
139
266
245
Note: includes all research INDs overseen by CDER, adjusted for submissions held due to agency concerns
Sources: Tufts CSDD
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)
By Extension… Study Volunteers
•
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
‘Who makes a better
contribution to mankind?’
Primary Strategies
•
Assurances
•
Sources of Volunteers
•
Technology solutions
•
Distribution Channels
Primary Strategies
•
•
Assurances
• Professional certification and training
• FDAA and publishing requirements
• IRB accreditation
Sources of Volunteers
• Extended global reach
• ‘Hedging’ recruitment risk
Distribution of FDA-Regulated
Investigators
Sources: Tufts CSDD
Global Backlash
Lancet 371; 2008
‘Hedging’ Recruitment Risk
Number of PIs Per Active IND
* Includes all research INDs, adjusted for submissions
held due to agency concerns
Sources: Tufts CSDD
Mean Number of Patients per NDA
* Does not include volunteers that participated in clinical
studies not included with the NDA submission.
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
Changing Recruitment Approaches
Incidence of Volunteers from External Sources
Source: CenterWatch Surveys of Investigative sites
A Growing Arsenal of Recruitment Tools
Static Patient Data
Chart Review
Claims Data
Lab Data
Dynamic Patient Data
Health system information exchange
Electronic medical records
Multi-media advertising
and promotion
Newspapers; craiglist; radio, television,
Internet listings
‘Opted-in’ Patient data
Internet-based communities
Social Networks
Online community forums (‘Pull’),
Twitter (‘Push’)
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
Support for Long Term Success
SUSTAIN
(Community
of Participants
and
Ambassadors)
RECRUIT
& RETAIN
ENHANCE
(General
Education and
Awareness)
ENABLE
(Support
Network and
Tools)
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
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’
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
2.9 Patients/Month
4.0 Patients/Month
38%
4.0 Patient/Month
9.6 Patients/Month
140%
WAVE 1
WAVE 2
Note: Pilot test involved two pain studies; 30 sites across 18 markets throughout the US
Source: Eli Lilly & Company, 2007
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%
Annual Growth Rate
Rising Protocol Design Complexity
Sources: Tufts CSDD analysis of 10,038 protocols, 2000-2006
Compensation per Procedure
Cycle Time Metrics
Median Days Elapsed
69% - 75% Increase
Source: Tufts CSDD
12% – 20% Increase
Conclusions
SUSTAIN
(Community
of Participants
and
Ambassadors)
RECRUIT
& RETAIN
ENHANCE
(General
Education and
Awareness)
ENABLE
(Support
Network and
Tools)
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