best practices in patient recruitment

BEST PRACTICES IN
P R E V I E W
O F
BEST PRACTICES
IN PATIENT
RECRUITMENT
A U G U S T,
2 0 1 6
Introduction
SMARTER QUESTIONS
SMARTER ANSWERS
REPORT OVERVIEW
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.
210
PAGES
304
CHARTS AND
GRAPHS
VALUABLE FOR
CLINICAL OPERATIONS CLINICAL DEVELOPMENT EXECUTIVE MANAGEMENT PATIENT RECRUITMENT INVESTIGATORS & SITE MANAGERS
THERAPEUTIC AREA HEADS
SITE RESEARCH COORDINATORS
DATA
COLLECTION
IN Q1, 2016
20-MINUTE
WEB-BASED
SURVEY
103 RESPONDENTS
FROM SPONSORS,
CROS AND SITES
SITE PRINCIPAL INVESTIGATORS
WHAT YOU WILL LEARN
•
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
How you can use this report
•
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
MAJOR
SECTIONS:
1. Facilitators & Barriers
to Patient Recruitment
Success
2. Specialized Patient
Recruitment Firms
Market Overview
3. CRO Performance Ratings
on Patient Recruitment
FOR PHARMA
4. Study Data
Shortlist strong performing CROs and Specialized Patient Recruitment
Firms for future patient recruitment needs
Full Table of Contents on
next page.
FOR SERVICE PROVIDERS
Benchmark your company against the competition in terms of meeting
client expectations, satisfaction, and quality
Introduction
SMARTER QUESTIONS
SMARTER ANSWERS
TABLE OF CONTENTS
COPYRIGHT AND USAGE GUIDE
Sites
INTRODUCTION
Specialized patient recruitment
firm scorecards
METHODOLOGY
Current and future patient
recruiting tactics
Sponsors
PARTICIPANT CRITERIA
Budget
CROs
FACILITATORS & BARRIERS TO PATIENT
RECRUITMENT SUCCESS
Capabilities
Sites
Timing
Source of patients recruited
Primary Findings
Scorecard performance summary
Sponsors
Which entity has the greatest
impact on recruitment success?
Quality index performance ratings
Recruitment success
drivers — unprompted
Recruitment success
drivers — prompted
CRO PERFORMANCE RATINGS
ON PATIENT RECRUITMENT
Sponsors
Primary Findings
CROs
CRO patient
recruitment scorecards
Sites
Specialized patient recruitment
firm performance
Budget — sponsors
Current and future patient
recruitment tactics
Capabilities — sponsors
Sponsors
Timing — sponsors
CROs
Capabilities — sites
Sites
Timing — sites
CROs
Sites
Quality index performance ratings
Recruiting patients for
global programs
Value of specialized patient
recruitment firms’ recruiting efforts
Sponsors
Sponsors
Sites
CROs
Patient recruitment challenges in
global clinical trials — unprompted
STUDY DATA
Global trial country
selection factors
Entity with the most power to
impact recruitment success
Strategies for specialized patient
recruitment firm use
Recruitment success
drivers – unprompted
Importance of specialized patient
recruitment services
Recruitment success
drivers – prompted
Sponsors
Sites
Recency of using patient recruitment services
SPECIALIZED PATIENT RECRUITMENT
FIRMS MARKET OVERVIEW
Primary Findings
Source of patients recruited
Sponsors
Specialized patient recruitment
firm usage
Sponsors
Sites
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 recruiting
firm use
Value of recruitment tactics
Sponsors
Specialized patient recruitment firm
performance ratings
Sponsors
CROs
Patient recruitment services
meeting expectations
Sponsors
Sites
Sites
CROs
Most important aspects of
specialized patient recruitment
firm services
Specialized patient recruitment
firms offer more value than
additional sites
CRO PATIENT RECRUITMENT
DRILL-DOWNS
Recruitment vendor structure for
global programs
Challenges faced in recruiting
patients into global clinical
trials – unprompted
Bioskin
Global trial country
selection factors
Value of recruitment tactics
Chiltern (including Theorem)
Sponsors
Clinical Research Services (CRS)
CROs
Clinipace
Sites
Clinlogix
Accell
Accelovance
Accenture
BioClinica
Celerion
Introduction
SMARTER QUESTIONS
SMARTER ANSWERS
TABLE OF CONTENTS
Clinsys
CAHG Trials
Cognizant
Clariness
Covance
Clinical List America
DaVita Clinical Research
Clinical Site Services
DCRI-Duke
Clinical Trial Media
Encorium
DAC Patient Recruitment Services
Eurofins
MediciGlobal
Eurotrials
MMG
Frontage
PatientsLikeMe
HungaroTrial
Patient Recruiters International
ICON
Praxis Communications
Inamed
INC Research
Resolutions Rapid
Enrollment Solutions
inVentiv Health Clinical
Synexus
KCR
The Patient Recruiting Agency
Lambda
Medpace
Threewire
RESPONDENT PROFILE
Medsource
Organization type
NAMSA
Responsibilities
Novotech
Interaction with functions
PAREXEL
Pharm-Olam International
ABOUT INDUSTRY STANDARD
RESEARCH
PPD
PRA
Premier Research
ProTrials
QPS
Quintiles
Rho
SanaClis
SGS Life Sciences
Southern Star
SPRI Clinical Trials
Symbio
SynteractHCR
Tata
TKL Research
304
CHARTS
AND GRAPHS
West Coast Clinical Trials
Worldwide Clinical Trials
SPECIALIZED PATIENT RECRUITMENT
FIRM DRILL-DOWNS
Academic Network (a
Stericycle company)
Acurian (a PPD company)
BBK Worldwide
SAMPLE PAGES
Introduction
SMARTER QUESTIONS
SMARTER ANSWERS
S A M P L E
P A G E :
RECRUITING PATIENTS FOR GLOBAL
PROGRAMS
This 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.
Introduction
FACILITATORS & BARRIERS TO PATIENT RECRUITMENT SUCCESS
Recruiting patients for global
programspatients for global programs
Recruiting
Sponsors
CROs
differ
theirapproaches
approaches to
to recruiting
forfor
global
programs.
Sponsors
are are
Sponsors
andand
CROs
differ
in in
their
recruitingpatients
patients
global
programs�
Sponsors
to engage
one
recruitmentvendor
vendor for
than
CROs
(64%(64%
vs 47%).
More More
than
moremore
likelylikely
to engage
one
recruitment
for the
theentire
entireprogram
program
than
CROs
vs 47%)�
half of the respondents from CROs report they engage multiple firms in some form to recruit for global
than programs.
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…?”
“For a global program, do you most often…?”
Sponsors (n=58)
CROs (n=19)
64%
Use one recruitment vendor for the entire program
47%
© Industry Standard Research
22%
Select one company for the home country and
another for all other countries
11%
10%
Select one company for each country or region
included in the study
26%
3%
Mix methods/Case by case decision
16%
0%
20%
40%
60%
80%
% of Respondents
DATA IN FULL REPORT
www.ISRreports.com ©2016
18
Best BEST Practices
in Patient Recruitment
PRACTICES IN PATIENT RECRUITMENT 22
Introduction
SMARTER QUESTIONS
S A M P L E
SMARTER ANSWERS
P A G E :
Introduction
SPECIALIZED PATIENT RECRUITMENT FIRMS MARKET OVERVIEW
UTILIZATION
STRATEGIES
Utilizationstrategies
strategies
Utilization
Among CROs, use of specialized
recruitment firms to accelerate
timelines (27%) stands out
as the most popular strategy
for engaging a specialized
recruitment firm.
Sponsors use specialized recruitment firms for a variety of reasons, with no single strategy standing out
Sponsors
use specialized
for a variety
of reasons,
with no
single
standing out
as a primary
motivationrecruitment
for engaging firms
a specialized
recruitment
firm. Among
CROs,
usestrategy
of specialized
recruitment
firms to accelerate
timelines
(27%) stands
out as the most
for engaging
a
as a primary
motivation
for engaging
a specialized
recruitment
firm� popular
Amongstrategy
CROs, use
of specialized
specialized
recruitment
firm.
recruitment firms to accelerate timelines (27%) stands out as the most popular strategy for engaging a
specialized
recruitment
firm�studies do you utilize a specialized recruitment vendor for the following
“On what
percent of your
strategies?”
“On what percent of your studies do you utilize a specialized recruitment vendor for the following strategies?”
Sponsors (n=60)
CROs (n=18)
Introduction
SPECIALIZED PATIENT RECRUITMENT FIRMS MARKET OVERVIEW
15%
Speed from the onset (use additional resources to
increase recruitment from the start of the study)
11%
Rescue (bring in a vendor mid-trial when you
anticipate or are experiencing lower-than-anticipated
site enrollment rates and delays)
11%
14%
DATA IN FULL REPORT
Acceleration (in a highly competitive scenario where
you need to shorten enrollment timelines with the
same number of sites)
Utilizationstrategies
strategies
Utilization
14%
27%
© Industry Standard Research
Risk Mitigation (using your same number of sites, use
the recruitment company's "reserve of patients" as a
12%
15%
the event of a site enrollment fall off)
Sponsors use specialized recruitment firms for a variety of reasons, withbuffer
noinsingle
strategy standing out
Sponsors
use specialized
for a variety
of reasons,
with no
single
standing out
as a primary
motivationrecruitment
for engaging firms
a specialized
recruitment
firm. Among
CROs,
usestrategy
of specialized
recruitment
firms to accelerate
timelines
(27%) stands
out as the most
popular
strategy
for engaging
a
as a primary
motivation
for engaging
a specialized
recruitment
firm� Unknown
Among
CROs,
use
of specialized
therapeutic
area (when
a study
is in a TA
specialized
recruitment
firm. timelines (27%) stands out as the most popular
you have little experience in)
recruitment
firms
to accelerate
strategy for engaging a 6%
12%
specialized
recruitment
firm�studies do you utilize a specialized recruitment vendor for the following
“On what
percent of your
High efficiency (reduce the number of sites to achieve
strategies?”
the same # of patients)
“On what percent of your studies do you utilize a specialized recruitment vendor for the following strategies?”
Sponsors (n=60)
0%
CROs (n=18)
11%
18%
10%
20%
30%
% of Studies
15%
Speed from the onset (use additional resources to
increase recruitment from the start of the study)
11%
www.ISRreports.com ©2016
Best Practices in Patient Recruitment
BEST PRACTICES IN PATIENT RECRUITMENT Rescue (bring in a vendor mid-trial when you
anticipate or are experiencing lower-than-anticipated
site enrollment rates and delays)
25
28
14%
11%
Acceleration (in a highly competitive scenario where
you need to shorten enrollment timelines with the
same number of sites)
C L O S E R
14%
27%
© Industry Standard Research
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)
12%
15%
12%
Unknown therapeutic area (when a study is in a TA
you have little experience in)
6%
<< 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:
11%
High efficiency (reduce the number of sites to achieve
the same # of patients)
L O O K
18%
www.ISRreports.com
0%
10%
20%
% of Studies
30%
Introduction
SMARTER QUESTIONS
SMARTER ANSWERS
S A M P L E
P A G E :
CRO PATIENT RECRUITMENT SCORECARDS
This page shows how 16 CROs were rated by sponsors on their patient recruitment
capabilities, enabling readers to quickly identify leaders in the industry.
Cost per
patient
The full data is available in the report, which can be downloaded
from www.ISRreports.com.
randomized
into the trial
Academic Network (a Stericycle company) (n=10)
Acurian (n=14)
Introduction
Clinical Site Services (n=11)
CRO PERFORMANCE
RATINGS ON PATIENT RECRUITMENT
Patient Recruiters International (n=10)
Praxis Communications (n=11)
The Patient Recruiting Agency (n=13)
DaVita Clinical Research
Capabilities — sponsors
Eurofins
ICON
Ability to
provide
transparency of
recruitment
inVentiv Health Clinical
performance
throughout the
process
Lambda
INC Research
Accenture
Company
#1 (n=16)
BioClinica
Company
#2 (n=14)
Chiltern (including
Theorem)
Company
#3 (n=13)
Number of
patients
who pass
the
screening
criteria
Quality of
referred
patients that
pass the
screening
criteria
Medpace
Novotech
PAREXEL
PPD
Clinical Research Services
(CRS)
Company
#4 (n=14)
PRA
Cognizant
Company
#5 (n=15)
QPS
Company
#6 (n=28)
Covance
Company
#7 (n=11)
DCRI-Duke
Ability to
support
patient
retention
throughout
the trial
Quintiles
Quotient Clinical
Company
#8 (n=10)
Eurofins
Rho
Company
#9 (n=29)
ICON
SGS Life Sciences
Company
#10 (n=14)
INC Research
SynteractHCR
Company
#11 (n=18)
inVentiv Health
Clinical
Company
#12 (n=33)
PAREXEL
Theorem
US Oncology
Company PPD
#13 (n=28)
Vince & Associates
Company PRA
#14 (n=20)
WCCT Global
Company
#15 (n=37)
Quintiles
Worldwide Clinical Trials
Company
#16 (n=15)
Worldwide
Clinical Trials
Ratings Key:
Clear leadership
Better than most
www.ISRreports.com ©2016
Ratings Key:
Clear leadership
About average
Falling a bit short
Likely deficiency
44
Best Practices in Patient Recruitment
Better than most
About average
Falling a bit short
Likely deficiency
Introduction
SMARTER QUESTIONS
SMARTER ANSWERS
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Introduction
SMARTER QUESTIONS
SMARTER ANSWERS
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ISR’S
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VS.
THE
COMMON
SYNDICATED
REPORT
ISR’S HEALTH PANEL
The industry’s fastest growing panel
of health care and pharmaceutical
professionals, with nearly 1,500
members worldwide.
Other 6%
CRO 6%
Research
Site 10%
RESEARCH METHODS
Mostly primary
research; always
appropriate for
the topic
BY
COMPANY
TYPE
One size
fits all; usually
publically
available data
Sponsor 78%
DATA COLLECTION
ISR’s proprietary data
tools and channels
support fast, high
quality data collection
Struggle to
recruit the right
targets and
enough of them
C-level 13%
Manager
29%
BY
JOB
LEVEL
RESPONDENTS
Sophisticated screening
ensures genuine
decision-makers
make up respondents
VP 10%
Undisclosed
methodologies
and respondent
demographics
Director 46%
SAMPLE SIZE
Robust
sample sizes
that instill
confidence
Often insufficient
industry representation
that leaves you
defending results
3-5 years 5%
6-10 years 11%
20+
years
37%
BY
EXPERIENCE
IN YEARS
ANALYSTS
Decades of experience
means more
insights that are
immediately usable
Junior analysts
capable of
reporting
numbers
11-15
years
24%
16-20 years 23%
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