NS-LIJ Powerpoint Template

PREP Course #17:
Are we there yet?
Achieving Enrollment Success
Cerdi Beltre, CIP, CCRP
Presented by:
Administrative Director, Clinical Research Service
Director, Clinical Research Operations, NSLIJ
516-562-0340, cbeltre@nshs.edu
Amanda Galvin
Recruitment Coordinator
Clinical Research Service
516-562-3645, agalvin@nshs.edu
CME Disclosure Statement
The North Shore LIJ Health System adheres to the ACCME’s new
Standards for Commercial Support. Any individuals in a position to
control the content of a CME activity, including faculty, planners, and
managers, are required to disclose all financial relationships with
commercial interests. All identified potential conflicts of interest are
thoroughly vetted by the North Shore-LIJ for fair balance and scientific
objectivity and to ensure appropriateness of patient care
recommendations.
•Course Director and Course Planners: Kevin Tracey, MD, Cynthia
Hahn, Emmelyn Kim, MPH, and Tina Chuck, MPH have nothing to
disclose.
•Course Speakers: Cerdi Beltre and Amanda Galvin have nothing to
disclose
Objectives and Content
Review recruitment plans and resources available to conduct human subject
research
• Discuss current state of recruitment across the health system
• Discuss why investigators/sites over-project on enrollment targets
• Review resources available to help meet enrollment goals
SOP on Recruitment and Retention
Subject Retention:
The relationships that the research team builds with
the subjects may be the most important factor in
continued participation; therefore, the following will
be incorporated as feasible and appropriate:
 take notes on subject’s interests and ask about it
at follow-up visits,
 provide helpful information about the disease
and resources at the health system,
 provide an appreciation package,
 gather the team for a proper goodbye,
 use of debit cards for visit compensation,
 Make-it-Right Cards for service recovery, and
 provide certificate of participation when their
participation is over.
Recruitment Plan Worksheet
Best Site Practices
Site Performance: Study Start-Up, Recruitment & Retention
SOPs
-Document
compliance
-Written study
recruitment
and retention
process/plan
Retention
Enrollment
Meets at least
70% of
enrollment goal
on each study
At least 70% of
patient
retention
IRB
Approval
-Within 30 days
from
independent
(commercial) IRB
-Within 60 days
from local IRB
Budget/
Contract
Responds
within 14 days
of receiving
documents
Society for Research Sites: Responsible Site Management, Best Site Practices. SCRS White Paper. October 2014
Facts and Figures
70% of research sites under-perform in the US
50% enroll zero to one patient
39% meet enrollment targets worldwide
13% exceed enrollment targets worldwide
New Research from Tufts Center for the Study of Drug Development Characterizes Effectiveness and
Variability of Patient Recruitment and Retention Practices, Press Release, Jan. 15, 2013
Pierre C. Recruitment and Retention in clinical trials: What works, what doesn’t and why. Presented at:
2006 Drug Information Association Annual Summit; June 2006; Philadelphia, PA
Don’t–Panic!
Facts and Figures
NSLIJ Comparison
70% of research sites under-perform in the US
• 82%
NSLIJ BRANY Q3 Closed
Studies (overall average
percentage of enrollment):
47%
50% enroll zero to one patients
• 40%
39% meet enrollment targets
• 13 out of 73 studies enrolled 70% or better
13% exceed enrollment targets
• 10%
NSLIJ figures based on BRANY Sept. 2014 enrollment report, excludes non-BRANY managed studies.
Zero Enrollment at NSLIJ (Q3 2014)
Closed by
sponsor
Site declined
to continue
with the study
Sponsor
delays/Late
add-on site
Enrollment
completed by
other sites (3)
Need central
service
support
Zero
Enrollment
Extension
study subjects didn't
want to
continue
-Assistance from
Marketing, CRS
-Limits on
distinguishing
individual site from
“NSLIJ/Feinstein“
Inadequate
process/plan
at site
Delay in
Hospitalists
referrals
Difficult
enrollment
criteria (6)
A snapshot…
Why do we overestimate enrollment targets?
Site:
Sponsor:
• Enthusiastic and optimistic
investigator
• Unrealistic – not based on
actual data (pts or time)
• “We’re doing great!“ Or “Better
than what we expected!”
• “If we didn’t give those
numbers, we wouldn’t have
been chosen”
• Fear sites can’t handle the
truth (demoralize or ruin the
relationship?)
• Keep performance metrics
including on enrollment – what
does your contract say?
Perception – Internal and External
Why does zero or low enrollment
matter?
• Uncompensated
impact of lowenrolling studies:
$1 million per
year
• Exposure to risk
without the
scientific or longterm clinical
benefit
• Diminished
ability to achieve
study objectives,
scientific/clinical
benefit
• Collaborations?
• Investments?
• Sponsorships?
Cost
Unethical
Medical
Advances
Future
Research
Shared goal: improving health and lives
Acad Med. Nov 2011; 86(11): 1360–1366. The Prevalence and Economic Impact of LowEnrolling Clinical Studies at an Academic Medical Center.
Acad Med. Nov 2011; 86(11): 1334–1335. Commentary: Improving Participant Recruitment
in Clinical and Translational Research
Pause and Evaluate
Feasibility/
Selection
• EMR data on
volume
• Investigator
and nonresearcher
physician
interest/
commitment
• Resources
Start-up/IRB
Study Conduct
• Evaluate
study
complexity,
competing
studies,
facilities, $
• Recruitment
plan –
passive and
active
recruitment
methods
• Plan A and B
• Track
enrollment
progress
Address Slow
Enrollment
• What is
working?
What’s not?
• Issues with:
-Protocol,
-Site,
-Investigator
/physician
engagement
-Patient
1. Can J Surg. Jun 2010; 53(3): 205–210. How to optimize patient recruitment
Post Study
Analysis
• Outcome
• How you
reached
that
outcome
• Lessons
learned
• Changes?
• Strengths
Performance Metrics
Who is tracking performance?
Sponsors/CROs – from study start-up to CRF queries per patient
Metrics Champion Consortium – 10 objective measures from the
sponsor/CRO perspective
Transcelerate –investigator registry and shared portal
Research Resonance Network – benchmark performance metrics from
the site’s perspective
Others – including us…
Performance Metrics – Report Card
1. How valuable would it be for you to receive a “post-study site report
card” for your site from the Sponsor showing your site’s performance
metrics against the study norms on such items as query rate, turn
around time, screen failure, etc.?
-Majority of respondents noted it would be “Extremely valuable”
2. If you received a “post-study site report card” would it change how you
conduct your work?
-Majority of respondents indicated “Definitely”
Society for Research Sites: The Quest for Site Quality and Sustainability, Perceptions, Principles
and Best Practices. SCRS White Paper. October 2014
Thank you!
Recruitment Resources and
Strategies
Amanda Galvin
Recruitment Coordinator
Clinical Research Service
Resources
•
•
•
•
•
•
•
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EMR
Physician Communication
Public Relations
Recruitment Registry
HealthPort
E-News Bulletin
Feinstein Website
Community Relations
Use of Electronic Medical Records
Leverage the health system EMR database to find out where
patients with your study’s specific eligibility criteria are
located.
•Real time patient identification for recruitment
•Reports sent at frequency of your choice (weekly, daily, etc)
Use reports to:
•Find inpatients in hospital
•Find outpatients by reviewing appointment data (and approach
patients during their visit if physician approves)
•Contact the patient’s physician to inform them of your study and
ask if they would refer eligible patients
Contact Annette Lee, Ph.D, Assoc. Investigator
Use of Electronic Medical Records
Example project: Sepsis study
• Identify early signs of sepsis in inpatients at NSLIJ
• Time sensitive subject enrollment (patients enrolled
within a specific time frame)
• Using selection criteria, generated reports (per hospital)
of potential participants
Physician Communication
• Physician Lists
– Based on therapeutic area and geographic
location
• Physician Liaison Team (all physicians team has visited)
• Credentialing Office (all NSLIJ physicians)
• Advertisement Distribution
– Physician liaison team will provide physicians with research
advertisements during their normal office visits
Public Relations
Helps to promote and publicize studies in a variety of ways
• Local media
• Internal communications across the health system
• Newsletters that are distributed throughout NY
Contact Emily Ng, Research Communications Manager
The Recruitment Registry
• Free and secure registry
• Participants of any age, race, ethnicity or health status can join
• NSLIJ investigators with an IRB approved protocol may request
lists of participants based on eligibility criteria and may contact
them to see if they would like to participate in their studies
• Over 800 participants currently enrolled and an online portal for
registration has been created
Contact Amanda Galvin, Recruitment Coordinator
Recruitment Registry Case Study
• Background
– Cognitive cancer study in which healthy volunteers needed
to enroll within 60 days of each patient.
– Healthy volunteers had to be the same gender and within
five years of age of the patient.
• Recruitment Method: Feinstein Recruitment Registry
– 9 out of the 16 healthy volunteers were from the
Recruitment Registry
“It has saved me so
much time. I don’t
know what I would
do without it”
HealthPort
• NSLIJ intranet system
• Advertise on the Events page
– advertisements can be set to repeat throughout the
year
Research Coordinators Feedback
“I found the healthport events
page extremely helpful when
recruiting healthy volunteers”
“By far our most successful
method for recruitment”
E-News Bulletin
• Weekly email to all NSLIJ employees (over 50,000)
• Advertise your research study
-Employees may have patients or know someone who is
eligible for your study
• Follow Content Guidelines and e-mail submissions to
E-NewsBulletin@nshs.edu by Tuesday at Noon
-Make sure to include in your email that language
provided can not be edited
http://northshorelij-news.com/1Y9P-34TJV-ABFTW5OB37/cr.aspx
Feinstein Institute Website Posting
•Advertise research studies to the community who may be
looking for studies to participate in
•Show fellow colleagues the research that is currently being
conducted
•Application can be found on the Feinstein Institute website
Resources for Investigators » Clinical Research Services »
Application & Request Forms » Post a study on Feinstein
website form
Contact Amanda Galvin, Recruitment Coordinator
Feinstein Institute Website Posting
Community Relations
• Helps increase awareness of clinical research by engaging and
collaborating with our communities.
• The NSLIJHS Community Advisory Board for Research Studies
(CAB) can provide advice about social, ethical and communal
matters to investigators conducting research, pre or post IRB
approval.
• Researchers that are interested in making presentations to
various communities about their work or at the CAB meeting
are welcome to contact this department.
Contact Gila Klein, Community Relations Manager
Other Resources
• Marketing
• Digital Strategy
• Call Center (receives ~52,000 calls every month)
The Recruitment Core is currently engaged in a
project where we plan to pilot various
recruitment strategies from these departments
Additional Strategies
• Internal Communication
• Community Outreach
– Support Groups
– Disease Specific Organizations
Internal Communication
• Build strong relationships with clinical teams including nurses
to promote clarity, understanding and support of the study
• PI’s to meet, speak and/or present study to clinical teams and
include a discussion of the importance of research and how it
will impact the future
• Meet and educate clinical teams on a regular basis and review
inclusion and exclusion criteria with them to keep them
informed, and also to keep the study relevant
Community Outreach
• Support groups
• Access to target population to promote study
• Members may be seeking new treatment options
• Collaborate and build strong relationships with advocacy groups,
foundations and other organizations
• Advertise study in newsletters, e-mails, social media, and other
material that organizations send to their members
• Participate in events, talks and other educational initiatives
• Attend disease-specific meetings to increase physician referrals
• Active community presence
• Have research team available to community to answer questions
and give advice which helps build trust
Questions?
Comments?
Concerns?