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

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Speaker Introduction

Melynda’s 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 DAC’s 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.

Diana is an industry veteran with 30

years of experience. She’s been an

entrepreneur and business owner

and strategic consultant to some of

the industry’s leading companies.

Diana is a sought after public

speaker, and we are fortunate to

have her with us today.

Speaker Introduction

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Setting the Stage

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• 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

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1) Bharmal et al. Direct-to-Patient Enrollment Strategies. Sept. 1, 20102) J. Hess, "Web-based Patient Recruitment,” Cutting Edge Information, 2005

Study Success = Strong Site Partnerships

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Insight from SMO Experience

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• Sites “ARE” relationship managers

• Key relationship for patients is with the investigators and study coordinators

• Sites “ARE” 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 “NOT” 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 Aren’t and

How They are Evaluated by Sponsors

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Methods Used to Partner with Sites

Resulting in Success for Sites and the Study

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• Give the sites a “voice” 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 – 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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• 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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• 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 – you!

• And lastly….. Consider not allowing the sites the OPTION to use

contracted PRR services

• Sponsors are making the investment – why not maximize ROI by

encouraging all sites to participate

Establishing Success in Sites

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The Process of Building a Partnering

Environment

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Patient Recruitment

Firm

CRO Sponsor

Site Patients

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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Strategies for Building Site Collaboration

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First Impressions

Feasibility Detail

ResponsivenessNegotiation

Style

Continuum for Success

Phase 1 – Initial Impression

1. Approached About Study – Response Time is Key

2. Open to Dialogue Not Just Electronic Communication

Phase 2 – Feasibility and Recruitment Tieback

1. Feasibility Discussions Include Honest, Concise Feedback

2. Return of Feasibility Documents Quickly

Steps to Success

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Phase 3 – 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

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Phase 4 – 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 “Site Empowerment: Setting your Site up for Success,” Forte Research Systems, March 20, 2015

• Helping Sites Craft a Personality that Attracts Sponsor Interest

How Creative, Responsive, and Willing to Try New Strategies

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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The Number of Patients Predicted to be Enrolled

as it Stands Alone – Without Assessment of the

Previous Steps – is Meaningless

Critical Element of Recruitment Planning

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• Stipend to “Prepare and Participate” 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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IDEA:

• Create a Site PERSONALITY SURVEY – 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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• Does Not Agree to Just “Any Study”

• 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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Know Oneself

Skills to Promote Strengths and Standout in the Pack

Uncover the Sites Reputation in Recruitment/Retention

Help Sites to Create a “Scorecard” of

Excellence

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• Intentional “Friendships” 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

Melynda Geurts, M.S.Vice President, Operations, DAC

mgeurts@dacprs.com

Diana Foster, Ph.D.Industry Consultant

dandersonfoster@gmail.com