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BEST PRACTICES IN PATIENT RECRUITMENT A U G U S T , 2 0 1 6
P R E V I E W O F
BEST PRACTICES IN
REPORT OVERVIEW
WHAT YOU WILL LEARN
How you can use this report
Patient recruitment is a primary concern of the clinical trial industry. Every day that a clinical trial goes beyond its intended deadline the sponsor organization could lose hundreds of thousands to millions of dollars in sales. Sponsors, CROs, and sites engage various means to reach key milestones on time and within budget. To provide the best perspective on this critical topic, ISR gathered opinions from key decision-makers at three different types of stakeholder organizations: sponsors, CROs, and sites. Further, we explored the increasingly important role of specialized patient recruitment firms by examining their market penetration, value, and performance.
D A T A C O L L E C T I O N I N Q 1 , 2 0 1 6
2 0 - M I N U T E W E B - B A S E D
S U R V E Y
1 0 3 R E S P O N D E N T S F R O M S P O N S O R S , C R O S A N D S I T E S
210 PAGES
304 CHARTS AND
GRAPHS
VALUABLE FOR
• Which entity (sponsor, CRO or site) has the greatest potential to impact patient recruitment success and why
• Key drivers to successful patient recruitment, including which study characteristics impact participation
• Respondents’ insight into their approach to recruiting for a global trial, including country selection factors and challenges for which to be prepared
• Know when and how to engage a specialized patient recruitment firm to get the best value
• Understand the value of various patient recruitment tactics and the best sources for recruiting patients
• Employ best practices identified by industry peers to improve the likelihood your clinical trial will be completed on-time and within budget
FOR PHARMA
FOR SERVICE PROVIDERS
Shortlist strong performing CROs and Specialized Patient Recruitment Firms for future patient recruitment needs
Benchmark your company against the competition in terms of meeting client expectations, satisfaction, and quality
Introduction
SMARTER QUESTIONS SMARTER ANSWERS
CLINICAL OPERATIONS CLINICAL DEVELOPMENT
EXECUTIVE MANAGEMENT PATIENT RECRUITMENT
INVESTIGATORS & SITE MANAGERS
THERAPEUTIC AREA HEADS
SITE RESEARCH COORDINATORS
SITE PRINCIPAL INVESTIGATORS
Full Table of Contents on next page.
MAJOR SECTIONS:1. Facilitators & Barriers
to Patient Recruitment Success
2. Specialized Patient Recruitment Firms Market Overview
3. CRO Performance Ratings on Patient Recruitment
4. Study Data
Introduction
SMARTER QUESTIONS SMARTER ANSWERS
COPYRIGHT AND USAGE GUIDE
INTRODUCTION
METHODOLOGY
PARTICIPANT CRITERIA
FACILITATORS & BARRIERS TO PATIENT
RECRUITMENT SUCCESS
Primary Findings
Which entity has the greatest
impact on recruitment success?
Recruitment success
drivers — unprompted
Recruitment success
drivers — prompted
Value of recruitment tactics
Current and future patient
recruitment tactics
Sponsors
CROs
Sites
Recruiting patients for
global programs
Patient recruitment challenges in
global clinical trials — unprompted
Global trial country
selection factors
SPECIALIZED PATIENT RECRUITMENT
FIRMS MARKET OVERVIEW
Primary Findings
Source of patients recruited
Sponsors
Specialized patient recruitment
firm usage
Utilization strategies
Importance of specialized patient
recruitment firm services
Specialized patient recruitment
firms provide more value than
adding sites
Specialized patient recruitment firm
use by company
Sponsors
CROs
Sites
Specialized patient recruitment firm
performance ratings
Sponsors
CROs
Sites
Specialized patient recruitment
firm scorecards
Budget
Capabilities
Timing
Scorecard performance summary
Quality index performance ratings
CRO PERFORMANCE RATINGS
ON PATIENT RECRUITMENT
Primary Findings
CRO patient
recruitment scorecards
Budget — sponsors
Capabilities — sponsors
Timing — sponsors
Capabilities — sites
Timing — sites
Quality index performance ratings
Sponsors
Sites
STUDY DATA
Entity with the most power to
impact recruitment success
Recruitment success
drivers – unprompted
Recruitment success
drivers – prompted
Recency of using patient
recruitment services
Sponsors
Sites
Patient recruitment services
meeting expectations
Sponsors
Sites
Recruitment vendor structure for
global programs
Challenges faced in recruiting
patients into global clinical
trials – unprompted
Global trial country
selection factors
Value of recruitment tactics
Sponsors
CROs
Sites
Current and future patient
recruiting tactics
Sponsors
CROs
Sites
Source of patients recruited
Sponsors
Specialized patient recruiting
firm use
Sponsors
CROs
Sites
Specialized patient recruitment
firm performance
Sponsors
CROs
Sites
Value of specialized patient
recruitment firms’ recruiting efforts
Sponsors
CROs
Sites
Strategies for specialized patient
recruitment firm use
Importance of specialized patient
recruitment services
Sponsors
CROs
Sites
Most important aspects of
specialized patient recruitment
firm services
Specialized patient recruitment
firms offer more value than
additional sites
CRO PATIENT RECRUITMENT
DRILL-DOWNS
Accell
Accelovance
Accenture
BioClinica
Bioskin
Celerion
Chiltern (including Theorem)
Clinical Research Services (CRS)
Clinipace
Clinlogix
TABLE OF CONTENTS
Introduction
SMARTER QUESTIONS SMARTER ANSWERS
Clinsys
Cognizant
Covance
DaVita Clinical Research
DCRI-Duke
Encorium
Eurofins
Eurotrials
Frontage
HungaroTrial
ICON
Inamed
INC Research
inVentiv Health Clinical
KCR
Lambda
Medpace
Medsource
NAMSA
Novotech
PAREXEL
Pharm-Olam International
PPD
PRA
Premier Research
ProTrials
QPS
Quintiles
Rho
SanaClis
SGS Life Sciences
Southern Star
SPRI Clinical Trials
Symbio
SynteractHCR
Tata
TKL Research
West Coast Clinical Trials
Worldwide Clinical Trials
SPECIALIZED PATIENT RECRUITMENT
FIRM DRILL-DOWNS
Academic Network (a
Stericycle company)
Acurian (a PPD company)
BBK Worldwide
CAHG Trials
Clariness
Clinical List America
Clinical Site Services
Clinical Trial Media
DAC Patient Recruitment Services
MediciGlobal
MMG
PatientsLikeMe
Patient Recruiters International
Praxis Communications
Resolutions Rapid
Enrollment Solutions
Synexus
The Patient Recruiting Agency
Threewire
RESPONDENT PROFILE
Organization type
Responsibilities
Interaction with functions
ABOUT INDUSTRY STANDARD
RESEARCH
304CHARTS
AND GRAPHS
SAMPLE PAGES
TABLE OF CONTENTS
Introduction
SMARTER QUESTIONS SMARTER ANSWERS
Introduction
FACILITATORS & BARRIERS TO PATIENT RECRUITMENT SUCCESS
Best Practices in Patient Recruitment 18www.ISRreports.com ©2016
Sponsors and CROs differ in their approaches to recruiting patients for global programs� Sponsors are more likely to engage one recruitment vendor for the entire program than CROs (64% vs 47%)� More than half of the respondents from CROs report they engage multiple firms in some form to recruit for global programs�
“For a global program, do you most often…?”
Recruiting patients for global programs
BEST PRACTICES IN PATIENT RECRUITMENT
22
Recruiting patients for global programs Sponsors and CROs differ in their approaches to recruiting patients for global programs. Sponsors are more likely to engage one recruitment vendor for the entire program than CROs (64% vs 47%). More than half of the respondents from CROs report they engage multiple firms in some form to recruit for global programs. “For a global program, do you most often…?”
16%
26%
11%
47%
3%
10%
22%
64%
0% 20% 40% 60% 80%
Mix methods/Case by case decision
Select one company for each country or region included in the study
Select one company for the home country and another for all other countries
Use one recruitment vendor for the entire program
% of Respondents
Sponsors (n=58) CROs (n=19)
© Industry Standard Research
S A M P L E P A G E :
RECRUITING PATIENTS FOR GLOBAL PROGRAMSThis page shows how sponsors and CROs differ in their approaches to patient recruitment for global programs.
The full data is available in the report, which can be downloaded from www.ISRreports.com.
D A T A I N F U L L R E P O R T
Introduction
SMARTER QUESTIONS SMARTER ANSWERS
Introduction
SPECIALIZED PATIENT RECRUITMENT FIRMS MARKET OVERVIEW
Best Practices in Patient Recruitment 25www.ISRreports.com ©2016
Utilization strategiesSponsors use specialized recruitment firms for a variety of reasons, with no single strategy standing out as a primary motivation for engaging a specialized recruitment firm� Among CROs, use of specialized recruitment firms to accelerate timelines (27%) stands out as the most popular strategy for engaging a specialized recruitment firm�
“On what percent of your studies do you utilize a specialized recruitment vendor for the following strategies?”
BEST PRACTICES IN PATIENT RECRUITMENT
28
Utilization strategies Sponsors use specialized recruitment firms for a variety of reasons, with no single strategy standing out as a primary motivation for engaging a specialized recruitment firm. Among CROs, use of specialized recruitment firms to accelerate timelines (27%) stands out as the most popular strategy for engaging a specialized recruitment firm. “On what percent of your studies do you utilize a specialized recruitment vendor for the following strategies?”
18%
6%
15%
27%
11%
11%
11%
12%
12%
14%
14%
15%
0% 10% 20% 30%
High efficiency (reduce the number of sites to achieve the same # of patients)
Unknown therapeutic area (when a study is in a TA you have little experience in)
Risk Mitigation (using your same number of sites, use the recruitment company's "reserve of patients" as a
buffer in the event of a site enrollment fall off)
Acceleration (in a highly competitive scenario where you need to shorten enrollment timelines with the
same number of sites)
Rescue (bring in a vendor mid-trial when you anticipate or are experiencing lower-than-anticipated
site enrollment rates and delays)
Speed from the onset (use additional resources to increase recruitment from the start of the study)
% of Studies
Sponsors (n=60) CROs (n=18)
© Industry Standard Research
S A M P L E P A G E :
UTILIZATION STRATEGIESAmong CROs, use of specialized recruitment firms to accelerate timelines (27%) stands out as the most popular strategy for engaging a specialized recruitment firm.
C L O S E R L O O K
<< CROs were least likely to cite an unkown therapeutic area as the reason to engage with a specialized recruitment vendor.
Data available in the full report, which can be found at:
www.ISRreports.com
Introduction
SPECIALIZED PATIENT RECRUITMENT FIRMS MARKET OVERVIEW
Best Practices in Patient Recruitment 25www.ISRreports.com ©2016
Utilization strategiesSponsors use specialized recruitment firms for a variety of reasons, with no single strategy standing out as a primary motivation for engaging a specialized recruitment firm� Among CROs, use of specialized recruitment firms to accelerate timelines (27%) stands out as the most popular strategy for engaging a specialized recruitment firm�
“On what percent of your studies do you utilize a specialized recruitment vendor for the following strategies?”
BEST PRACTICES IN PATIENT RECRUITMENT
28
Utilization strategies Sponsors use specialized recruitment firms for a variety of reasons, with no single strategy standing out as a primary motivation for engaging a specialized recruitment firm. Among CROs, use of specialized recruitment firms to accelerate timelines (27%) stands out as the most popular strategy for engaging a specialized recruitment firm. “On what percent of your studies do you utilize a specialized recruitment vendor for the following strategies?”
18%
6%
15%
27%
11%
11%
11%
12%
12%
14%
14%
15%
0% 10% 20% 30%
High efficiency (reduce the number of sites to achieve the same # of patients)
Unknown therapeutic area (when a study is in a TA you have little experience in)
Risk Mitigation (using your same number of sites, use the recruitment company's "reserve of patients" as a
buffer in the event of a site enrollment fall off)
Acceleration (in a highly competitive scenario where you need to shorten enrollment timelines with the
same number of sites)
Rescue (bring in a vendor mid-trial when you anticipate or are experiencing lower-than-anticipated
site enrollment rates and delays)
Speed from the onset (use additional resources to increase recruitment from the start of the study)
% of Studies
Sponsors (n=60) CROs (n=18)
© Industry Standard Research
D A T A I N F U L L R E P O R T
Introduction
SMARTER QUESTIONS SMARTER ANSWERS
Introduction
CRO PERFORMANCE RATINGS ON PATIENT RECRUITMENT
Best Practices in Patient Recruitment 44www.ISRreports.com ©2016
Capabilities — sponsors
Ratings Key: Clear leadership Better than most About average Falling a bit short Likely deficiency
Ability toprovide
transparency of recruitment
performance throughout the
process
Ability to support patient
retention throughout
the trial
Number of patients
who pass the
screening criteria
Quality of referred
patients that pass the
screening criteria
Accenture (n=16)
BioClinica (n=14)
Chiltern (including Theorem) (n=13)
Clinical Research Services (CRS) (n=14)
Cognizant (n=15)
Covance (n=28)
DCRI-Duke (n=11)
Eurofins (n=10)
ICON (n=29)
INC Research (n=14)
inVentiv Health Clinical (n=18)
PAREXEL (n=33)
PPD (n=28)
PRA (n=20)
Quintiles (n=37)
Worldwide Clinical Trials (n=15)
Ratings Key: Clear leadership Better than most About average Falling a bit short Likely deficiency
Cost per patient
randomized into the trial
Academic Network (a Stericycle company) (n=10)
Acurian (n=14)
Clinical Site Services (n=11)
Patient Recruiters International (n=10)
Praxis Communications (n=11)
The Patient Recruiting Agency (n=13)
DaVita Clinical Research
Eurofins
ICON
INC Research
inVentiv Health Clinical
Lambda
Medpace
Novotech
PAREXEL
PPD
PRA
QPS
Quintiles
Quotient Clinical
Rho
SGS Life Sciences
SynteractHCR
Theorem
US Oncology
Vince & Associates
WCCT Global
Worldwide Clinical Trials
S A M P L E P A G E :
CRO PATIENT RECRUITMENT SCORECARDSThis page shows how 16 CROs were rated by sponsors on their patient recruitment capabilities, enabling readers to quickly identify leaders in the industry.
The full data is available in the report, which can be downloaded from www.ISRreports.com.
Company #1
Company #2
Company #3
Company #4
Company #5
Company #6
Company #7
Company #8
Company #9
Company #10
Company #11
Company #12
Company #13
Company #14
Company #15
Company #16
Introduction
SMARTER QUESTIONS SMARTER ANSWERS
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Introduction
SMARTER QUESTIONS SMARTER ANSWERS
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VS.
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ISR’s proprietary data tools and channelssupport fast, high quality data collection
Struggle to recruit the right targets and enough of them
DATA COLLECTION
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ANALYSTS
ISR’S HEALTH PANELThe industry’s fastest growing panel of health care and pharmaceutical
professionals, with nearly 1,500 members worldwide.
BYJOB
LEVEL
Director 46%
Manager 29%
C-level 13%
VP 10%
BYEXPERIENCE
IN YEARS
16-20 years 23%
11-15 years 24%
6-10 years 11%
3-5 years 5%
20+ years 37%
BYCOMPANY
TYPE
Other 6%
Sponsor 78%
CRO 6%
ResearchSite 10%