One of the biggest challenges facing any clinical trial is how to identify the sites with the greatest potential to engage and retain patients. Applying decades of experience to the topic, Medpace experts will share considerations, lessons-learned and best practices for developing patient recruitment strategies to put you on the path for optimal success.
2. M A K I N G T H E C O M P L E X S E A M L E S S
• Patient recruitment challenges
• Using data sources for recruitment
• Identifying and engaging the right sites
• Effectively supporting patients
AGENDA
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4. M A K I N G T H E C O M P L E X S E A M L E S S
THE CHALLENGE
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CISCRP http://medrio.com/partners/wp-content/uploads/2015/11/Clinical-Trial-
Awareness-968px.png
5. M A K I N G T H E C O M P L E X S E A M L E S S
REASONS ENROLLMENT LAGS AT A SITE
• Protocol too restrictive
• PI and/or Study Coordinator not engaged
• Within practice
‒ Too few patients
‒ Competing trials
‒ Do not know how to disseminate protocol knowledge across practice including
satellites
‒ Not enough staff
• Going outside practice
‒ Referrals are rare
‒ Sites do not have the resources, time or skills to market direct to patients
effectively
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6. M A K I N G T H E C O M P L E X S E A M L E S S
The Leaky
Pipe
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7. M A K I N G T H E C O M P L E X S E A M L E S S
DEDICATED RECRUITMENT AND RETENTION PLAN
FASTER ENROLLMENT WITH FEWER DROPOUTS
Strategic management
Data-driven – experience refined
Preferred sites
Patient centricity
Recruitment and retention tools
Vendor Partnerships
Develop strategies and support
the clinical operations team
Use of internal and external data
Identify top performing sites for
faster study start up and enrollment
Enroll engaged patients
for greater patient satisfaction
Customized plans for each study
Advertising, social media,
big data partners, etc.
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9. M A K I N G T H E C O M P L E X S E A M L E S S
Refined, data-driven approach to
align a target population with
motivated and experienced
Investigators to create a precise
and effective recruitment strategy
PATIENT RECRUITMENT STRATEGY
DATA-DRIVEN. EXPERIENCE REFINED.
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10. M A K I N G T H E C O M P L E X S E A M L E S S
DATA DRIVEN
EXTERNAL AND INTERNAL DATA SOURCES
• Optimize external data: Use
global health research
platforms that offer
‒ Investigator insights
‒ Studies details
‒ Access to patient lives
• Use internal sources:
‒ Clinical study history
‒ Central laboratories
‒ Electronic Data Collection
‒ Imaging core labs
• Standard of care,
country-specific regulatory,
cultural considerations
• Prior site performance in the
indication
– Internal
– External
• KOL and Investigator
relationships
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11. M A K I N G T H E C O M P L E X S E A M L E S S
US and European maps illustrating the prevalence of the indication,
with overlying heat maps based on global health platform data.
EXPERIENCE CUTS THROUGH DATA LIMITATIONS
EXAMPLE SCENARIO
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Step 1: Heat maps based on epidemiological and global health data
12. M A K I N G T H E C O M P L E X S E A M L E S S
EXPERIENCE CUTS THROUGH DATA LIMITATIONS
EXAMPLE SCENARIO
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Step 2: Data analysis provides a more precise localization of
high-performing sites (gold cylinders)
Close-ups maps illustrating site
distribution.
• Each cylinder indicates a
site which has participated
in a previous study in the
indication, with height
representing the number
of studies.
• Gold cylinders represent high
performing sites in previous
studies.
14. M A K I N G T H E C O M P L E X S E A M L E S S
• Identifying the right sites is critical to achieving overall study start-up and
enrollment goals
‒ Feasibility is a critical touch point to assess a site’s ability to enroll the intended
patient population. The feasibility questionnaire should be specific and well targeted
‒ Site’s responsiveness during the feasibility process is a good indicator of future
dedication to trial success
‒ Qualification visits are key to ensure a site is able to conduct the trial as outlined in
the protocol
• Leveraging long-term site relationships will foster a more collaborative and
engaging trial experience
• Ensuring sites recruitment efforts are well supported allows them to focus
efforts on identification and enrollment of the targeted patient population
SITE SELECTION AND ENGAGEMENT
BOLSTERING RECRUITMENT FOR FASTER ENROLLMENT
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15. M A K I N G T H E C O M P L E X S E A M L E S S
• Build a strong RAPPORT with
study sites and referral sources
• Serve as an EXTENSION of the
site staff
‒ COLLABORATE to ensure that
strategies are accepted and
implemented ALLEVIATING
BURDENS on staff and keep
sites FOCUSED on enrollment
SITE ENGAGEMENT STRATEGIES
BOLSTER SITES’ RECRUITMENT EFFORTS TO MAXIMIZE ENROLLMENT AND MEET STUDY GOALS
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16. M A K I N G T H E C O M P L E X S E A M L E S S
PREFERRED SITES ADVANTAGES
• Consider a program that strategically aligns your top performing sites
• Benefits include:
‒ Dedicated contact that will focus on your studies
‒ Real-time feedback
• Protocol development and study design
• Recruitment and retention methods
‒ Strengthens your relationship for future study opportunities
‒ Typically first sites to be activated
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17. M A K I N G T H E C O M P L E X S E A M L E S S
PREFERRED SITE PROGRAM GOALS
• Develop relationships with elite sites
• Provide quality feedback for preliminary feasibility
• Expedite start-up and enrollment timelines
• Ensure fast and consistent enrollment
• Produce high quality data
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18. M A K I N G T H E C O M P L E X S E A M L E S S
SITE NETWORKS GOALS
• Similar to Preferred Site Program:
‒ Strategic relationships with site networks strengthen your capability to deliver
study patients
• Build trust and mutual professional respect within the networks for a
seamless and effective study start-up process
‒ Put MSA in place to expedite the feasibility and contracting phase
‒ Understand the network’s operations model
• Central contracting
• Central logistics
• Preferred networks are those that have sites in a variety of indications
and can start up quickly
• Consider monthly meetings with preferred network liaisons to discuss
study needs and upcoming work
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19. M A K I N G T H E C O M P L E X S E A M L E S S
CASE STUDY EXAMPLE: SITE ENGAGEMENT
FACIOSCAPULOHUMERAL MUSCULAR DYSTROPHY
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Patients unknown to site staff, and therefore limited
medical history of patient before scheduling screening visit
Difficult I/E criteria, specifically the muscle strength
required of the patient for enrollment
Number of visits and study commitment
RECRUITMENT
CHALLENGES
20. M A K I N G T H E C O M P L E X S E A M L E S S
STUDY ENROLLMENT
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21. M A K I N G T H E C O M P L E X S E A M L E S S
KEY TAKEAWAYS
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Enrollment
goal met
earlier than
projected
Average
Screens
July –
October
11.25/Month
Average
Screens
April – June
7.5/Month
23. M A K I N G T H E C O M P L E X S E A M L E S S
PROTOCOL DEVELOPMENT
PATIENT-FOCUSED STRATEGIES
Patient
Advocates
Understand
the Patient
Select the
Right Tools
Relationships can be
key to success
Engaged patients –
fewer protocol
amendments
Higher recruitment
and retention
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24. M A K I N G T H E C O M P L E X S E A M L E S S
FORMING LASTING PARTNERSHIPS
RELATIONSHIPS MATTER
• Early engagement increases likelihood of developing
true partnerships
• Ensure opinions and shared experiences are being
heard in the development of new therapies
• Actively engaged in protocol review
‒ Power of their voice
• Examples of study awareness opportunities:
‒ Website listing on advocacy group websites
‒ Newsletter placements, informing members of the study
‒ Patient email blasts from advocacy group membership list
‒ Other "outside the box" places that the study population
may be found and study information can be shared
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Patient
Advocates
Relationships can be
key to success
25. M A K I N G T H E C O M P L E X S E A M L E S S
• Why should patients consider trial participation?
‒ Seek patient/caregiver buy-in by clearly stating why your
clinical trial is their best option
‒ Listen to their questions and make sure they feel as if their
voices are being heard
• Don’t be afraid to use social influences to get your
message to patients. This includes Facebook posts,
blogs, articles and paid and free promotion
KNOW THE KEY DRIVERS FOR THE PATIENT POPULATION
ENGAGING PATIENTS EFFECTIVELY
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Understand
the Patient
Engaged patients –
fewer protocol
amendments
26. M A K I N G T H E C O M P L E X S E A M L E S S
ENGAGING PATIENTS IS MORE THAN JUST
MATERIALS
• Be pro-active, Create a plan to
minimize risk of enrollment lagging
and retention issues
• Incorporate additional patient
engagement strategies
• Digital strategies such as online media
and social media advertising
• Training videos on protocol
requirements
• Participation support initiatives
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27. M A K I N G T H E C O M P L E X S E A M L E S S
PATIENT ENGAGEMENT OUTREACH
• Network with key influencers and
advocates within the community
• Educate patient and/or caregiver support
groups
• Canvas community for additional venues
to contact
• Distribute and display study materials
• Liaise at local therapeutic/community
health presentations and events
• Opportunities for coverage in local regular
publications, newsletters, web sites, etc.
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Raise
Community
Awareness
Engage
Referral
Networks
Optimize
Sites
Select the
Right Tools
Higher recruitment
and retention
28. M A K I N G T H E C O M P L E X S E A M L E S S
PATIENT RETENTION
• Providing patient and caregivers with the
appropriate support is critical for retention
• Addressing needs such as travel and
home health services eases the burden of
study participation
• Supplying items to sites which support
long visits such as entertainment tablets
allows for a better patient experience
• Acknowledging when patients achieve
study milestones shows appreciation for
their time commitment and reinvigorates
their commitment to continued study
participation
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Mitigate
participation
obstacles
Reinforce study
participation
Engaged
patient/caregiver
Select the
Right Tools
Higher recruitment
and retention
29. M A K I N G T H E C O M P L E X S E A M L E S S
KEY TAKEAWAYS
• Power of data coupled with thoughtful recruitment strategies
• Leveraging relationships
• Patient-centric focus
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Approved: Gina Steidle 3-22-2019
Data alone can lead to spurious conclusions
IntelliPACE overlays patient-level data with :
Prior site performance
Internal and external
KOL and Investigator relationships
Standard of care, country-specific regulatory, cultural considerations
Aligns the target population with motivated and experienced Investigators
Approved: Gina Steidle 3-22-2019
Global Health Research Platforms: access to public data and private global health research platforms providing information for over 400,000 investigators, across 300,000 studies, and involving more than 135 million patients, to supplement our internal metrics.
Medidata
TriNetX
Citeline
DataMonitor
Clinical Study History: Our proprietary study management system, ClinTrak®, provides years of Investigator start-up, enrollment, and quality performance metrics to enable identification of high-quality, reliable sites
Central Laboratories: a global repository of laboratory data drives sound recommendations relative to key inclusion/exclusion criteria to target investigators with the correct patient population
Electronic Data Collection: a wealth of information regarding inclusion/exclusion criteria and their effect on enrollment in similar studies can help to inform study design and recruitment
Imaging Core Labs: Assists with the identification of investigators in key therapeutic areas with access to specialized equipment and the experience required to conduct some of the most complicated studies currently designed
Approved: Gina Steidle 3-22-2019
The maps illustrate a search for sites with previous experience in a single indication. As a first step, Medpace utilized both epidemiological and global health research platforms to understand the location of patients throughout the US and EU. The epidemiology data show a high prevalence of the disease by state/ region in the US and EU, whereas the heat maps indicate pockets of patients surrounding sites conducting research. However, these data, in the absence of site performance metrics, could lead to erroneous conclusions regarding placement of the study.
Approved: Gina Steidle 3-22-2019
An analysis of site location indicates large numbers of sites that have conducted studies in the target indication. Overlaying performance data in prior clinical trials allows a more precise localization of high performing, quality sites (gold cylinders) relative to target population. These data highlight the importance of analyzing site performance on previous studies to effectively position the study with sites who are motivated to perform and have demonstrated prior success.
Provides sites with a dedicated Site Relationship Coordinator (SRC), acting as a single point of contact concierge service
Ensures sites are given high priority preference for all Medpace study feasibilities
Access to our resources thus improving patient access to innovative and cutting edge clinical studies
Offers enhanced management and support to help sites achieve success
PI involvement with protocol development and study design
Access to our wealth of experience and expertise, aiding in speedy and consistent patient enrollment
Strengthens industry partnership and provides industry insight, otherwise not available
Flagship Sites are typically first to be activated with some of the fastest industry timelines
What specific Medpace resources are they getting that they wouldn’t receive from being a non-Flagship site?
Sub-Is? Experienced CRCs?
Is this different than #4 or could we maybe combine the two?
Primary Objective: To develop vital relationships with lead sites, across the globe and to strengthen existing relationships with excelling sites, enabling us to deliver studies effectively to our Sponsors
Calls conducted with sites 18JUN-26JUL
Follow-up calls for targeted sites 26JUL-2AUG
Gathering patient feedback during the protocol development phase from patient advocates is a key ingredient in ensuring the study needs are aligned with advocacy efforts
Understanding the nuances of patient needs, especially in the development of the schedule of events, means a more engaged study participant and potential for less protocol amendments by addressing these needs upfront
Identifying study specific awareness and educational tools includes thoughtful insight into what’s important to the study subjects will lead to higher recruitment and retention rate
Patient advocates need to feel that their opinions and shared experiences are being heard in the development of new therapies. By engaging patient advocates upfront, the likelihood of developing true partnerships is increased.
Effectively building relationships with patient advocates means they are actively engaged in protocol review. Modifying your protocol based on their feedback will lend itself to positive word of mouth about the study in patient communities and potential referral networks
The list below is an example of potential study awareness opportunities that cans be available as a result of these partnerships:
Website listing under the clinical trial section of the advocacy group's website
Newsletter placements, informing members of the study
Patient email blasts from advocacy group membership list, directing members to learn more about the clinical trial opportunity
Other "outside the box" places that the study population may be found and study information can be shared
It is important to identify why patients would consider trial participation. Understanding these motivating factors are key to building a successful engagement program
Seek patient/Caregiver buy-in by clearing stating why your clinical trial is their best option
Listen to their questions and make sure they feel as if their voices are being heard
They are living with the condition and have to feel important in the decision making process
Don’t be afraid to use social influences to get you message to patients. This includes Facebook posts, blogs, articles and paid and free promotion
By utilizing Google AdWords to craft keyword-driven campaigns, sponsors, CROs, and investigator sites can reach a more targeted audience in a more cost effective manner than traditional recruitment channels like TV, radio, and print media allow for. Keep in mind that most patients today remain unaware that clinical trials are a viable treatment option, so keywords should relate to the specific condition and treatment, rather than clinical trials themselves. Avg 5+ hours/day on mobile device
62% users report searching for medical information on smartphone
Facebook’s user base has reached more than two billion users, in some cases representing 100% of a given population for certain chronic or rare conditions, including Parkinson’s and Alzheimer’s disease. Moreover, patients are becoming increasingly comfortable using Facebook to talk about their health conditions or meet people in similar circumstances.
Clinical trials can use Facebook’s unprecedented targeting capabilities to place ads in front of niche audiences. Whether they want to target based on age, race, gender, location, or even likes and dislikes, trials can ensure that their ads are only being shown to the right audiences at the right time. These ads are remarkably effective, too; Facebook’s ad response rate for clinical trials can be four to five times higher than banner ads on other platforms.
REF - https://www.mdconnectinc.com/medical-marketing-insights/new-clinical-trial-patient-recruitment-best-practices-for-2018