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Partnering with sites
1. Partnering with Sites to Leverage Recruitment
Success as a Business Development Strategy
DAC Patient Recruiting Services
Melynda Geurts, M.S.
Vice President, Operations, DAC
Diana Foster, Ph.D.
Industry Consultant
2. 2
Speaker Introduction
Melyndaâs career has focused on advancing education
within the healthcare industry for the past 23 years.
Since 1998, Melynda has shifted her focus to
educating the public about participating in clinical
trials through global programs. She currently serves as
the Vice President of Operations for DAC Patient
Recruitment Services, an Imperial Company. Melynda
is responsible for the strategic growth of the
organization and integral in ensuring DACâs position as
a leader within the patient recruitment and retention
niche.
Melynda is invited often to present and train
worldwide at industry conferences and has
contributed to the industry's overall body of literature
through her writing contributions. In 2008, she was
recognized by PharmaVoice as 100 Most Inspiring
People in Life Sciences.
3. Diana is an industry veteran with 30
years of experience. Sheâs been an
entrepreneur and business owner
and strategic consultant to some of
the industryâs leading companies.
Diana is a sought after public
speaker, and we are fortunate to
have her with us today.
Speaker Introduction
3
5. ⢠Patient recruiting causes 45% of delays in clinical trials1
⢠80% of trials fail to meet enrollment timelines2
⢠For each day delayed, millions of dollars are lost
⢠Sixty-six percent of sites only conduct one trial
⢠This requires constant retraining of site staff, which can impact overall
enrollment
Patient Recruitment CONTINUES to Delay
the Clinical Trial Process
5
1) Bharmal et al. Direct-to-Patient Enrollment Strategies. Sept. 1, 2010
2) J. Hess, "Web-based Patient Recruitment,â Cutting Edge Information, 2005
8. ⢠Sites âAREâ relationship managers
⢠Key relationship for patients is with the investigators and study coordinators
⢠Sites âAREâ enrollment specialists
⢠Sites are selected for their ability to enroll and manage clinical trials
⢠Sponsors are relying more heavily on big data for site identification vs.
feasibility information alone
⢠Available patient population is shrinking (protocol design) making external
recruitment support a necessity. For example, the number of patients
needed per NDA has increased from 1,500 in 1970 to more than 5,000
today.
⢠Sites are âNOTâ marketing experts nor should they be
⢠Site personnel are trained in the science of conducting clinical trials
⢠Recruitment specialists are trained in the marketing of clinical trials
What Sites Are, What They Arenât and
How They are Evaluated by Sponsors
8
9. Methods Used to Partner with Sites
Resulting in Success for Sites and the Study
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10. ⢠Give the sites a âvoiceâ in protocol design and recruitment program
development
⢠Conduct forums with just study coordinators whereby they can speak freely
and creatively brainstorm possible solutions to enrollment challenges
⢠Increases buy-in to the study design and utilization of external programs
offered
⢠Give back to the sites through certified trainings that offer the ability to
earn CEU credits.
⢠Trainings can be conducted at the investigator meeting and/or as a
separate meeting
⢠These type of trainings have shown to improve enrollment rates in both
rescue and proactive settings â For example, the rate of enrollment has
increased by 30% within 45 days post training in most cases
Establishing Success in Sites
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11. ⢠Educate sites that a patient recruitment and retention firm (PRR) has
been employed to assist their efforts
⢠If you choose to use an external PRR firm to support enrollment efforts, it is
imperative for the sponsor to introduce the PRR firm to the sites and
express their enthusiasm for being able to offer this level of service
⢠Proper introduction or lack thereof sets the stage for program acceptance
and utilization among the sites
⢠Establish open communication between sites and PRR firm to build
trust and credibility
⢠Ensure the sites understand the role of the PRR firm and the level of
support the sites will receive
Establishing Success in Sites
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12. ⢠Foster relationship between sites and PRR firm to establish
importance of the contracted program
⢠A successful campaign is only as successful as the sites make it.
Forging an effective campaign starts from the top â you!
⢠And lastlyâŚ.. Consider not allowing the sites the OPTION to use
contracted PRR services
⢠Sponsors are making the investment â why not maximize ROI by
encouraging all sites to participate
Establishing Success in Sites
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13. The Process of Building a Partnering
Environment
13
Patient
Recruitment
Firm
CRO Sponsor
Site Patients
14. Transparency During Feasibility
Site Selection and Budgeting Processes Are
Tied Together Closely Early in Discussions
Crafting an Open, Innovative, Team Approach
to Recruitment Partnering
Building Trust and Expectations Early
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15. Strategies for Building Site Collaboration
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First
Impressions
Feasibility
Detail
Responsiveness
Negotiation
Style
Continuum for Success
16. Phase 1 â Initial Impression
1. Approached About Study â Response Time is Key
2. Open to Dialogue Not Just Electronic Communication
Phase 2 â Feasibility and Recruitment Tieback
1. Feasibility Discussions Include Honest, Concise Feedback
2. Return of Feasibility Documents Quickly
Steps to Success
16
17. Phase 3 â Responsiveness
1. Willing to Spend Time to Review Recruitment Plan, What is Needed,
What Experience Does Site Have
2. Creativity and Innovation Are Discussed
Steps to Success
17
18. Phase 4 â Negotiations
Budget Negotiations are Clear and Transparent and Do Not Change
Dramatically
⢠Be open-minded to the budget counters you may receive and recognize
strong performing sites are highly sought after and know that they are
⢠Sites have increased their sophistication related to budget negotiations
Steps to Success
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1) L. Hilty âSite Empowerment: Setting your Site up for Success,â
Forte Research Systems, March 20, 2015
19. ⢠Helping Sites Craft a Personality that Attracts Sponsor Interest
ďź How Creative, Responsive, and Willing to Try New Strategies
ďź Personality = Coherent Patterning of Affect, Cognition and Desired Goal
Setting as it Leads to Behavior
Site Personality Relates Directly Back to
Recruitment Success
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20. The Number of Patients Predicted to be Enrolled
as it Stands Alone â Without Assessment of the
Previous Steps â is Meaningless
Critical Element of Recruitment Planning
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21. ⢠Stipend to âPrepare and Participateâ in Webinars
⢠Stipend for Time to Work with PRP Face to Face
⢠Creative Strategy Development
⢠Block Enrollment Tactics
⢠Recognition Programs
⢠Set Parameters in Clinical Trial Agreement
⢠Minimum 30 patients/Maximum 60 as an Example
Strategic Partnering Ideas to Strengthen Site
Selection and Emphasize Recruitment
Experience
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22. IDEA:
⢠Create a Site PERSONALITY SURVEY â Feedback on Dimensions of a
Successful Site from a Perspective of RECRUITMENT
⢠Helps Provide Ideas around Motivation and Character on What Makes a
Successful Site
Strategic Partnering with Site
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23. ⢠Does Not Agree to Just âAny Studyâ
⢠Sometimes Respectfully Reconsiders After Enrollment Assessment, but
Does So Appropriately
⢠Demonstrates Excellence
⢠Provides Real Data
⢠Illustrates Competitive Advantage
Qualities of a Good Site Prospect
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24. ďź Know Oneself
ďź Skills to Promote Strengths and Standout in the Pack
ďź Uncover the Sites Reputation in Recruitment/Retention
Help Sites to Create a âScorecardâ of
Excellence
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25. ⢠Intentional âFriendshipsâ Help Build Predictability in Enrollment
Success and Overall Study Outcomes
In Summary
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Common Sense + Effort + People Skills =
Commitment in Attaining Enrollment Goals
26. Melynda Geurts, M.S.
Vice President, Operations, DAC
mgeurts@dacprs.com
Diana Foster, Ph.D.
Industry Consultant
dandersonfoster@gmail.com