1. Referral Management and Pull Through: The importance of having a plan to maximize outreach investments and support sites during the recruitment campaigns Gretchen Goller, MSW Sr. Director, Patient Access and Retention Services Spring 2013 Forum on Optimizing Clinical Research Performance 21-MAY-2013

2. Disclosure I am an employee of PRA All opinions/statements made in this presentation are my own and do not represent the opinions or position of PRA

3. Patient Enrollment Inefficiencies 18-Aug-15 A Clear Difference 3 95% 80% 70% 50% 33% 95% of clinical trials fail to complete on time 80% of trial delays are due to unfulfilled enrollment 70% of sites don’t meet their enrollment goals 50% of sites enroll one or no patients 33% of consented patients complete a trial Source: Ciscrp.org

4. Patient Awareness and Interest 18-Aug-15 A Clear Difference 4 75% 70% 57% 44% 14% 75% of people have little to no knowledge about clinical trials and participation. >70% of those who have participated in a study would do so again 57% of Americans would likely participate in a study 44 % of people learn about studies through the media 14% of people gain information about studies from their physicians Source: Ciscrp.org

5. Why It’s so Critical 18-Aug-15 A Clear Difference 5 Source: Tufts Center for the Study of Drug Development

6. Referral Management Patient signs the informed consent form and begins screening Screening Visit Investigator or Study Coordinato r conduct additional follow-up with patient on interest in study participatio n Follow-up Patient First Office Visit (FOV) occurs FOV Study Coordinato r or other site staff contact patient to discuss study and gather further pre- qualificatio n details Follow-up Patient has shown interest and proactively provided personal health information to the site, call center, or an online survey Patient Outreach 18-Aug-15 A Clear Difference 6

7. Inefficiencies in Converting Patients 18-Aug-15 A Clear Difference 7 Patient Outreach Site Follow- up FOV Site Follow- up Screening Visit Site’s lack of interest in receiving external referrals Lack of communication to sites Site’s lack of interest in receiving external referrals Lack of communication to sites Lack of site support services Site capacity to process referrals and/or study fatigue Lack of site support services Site capacity to process referrals and/or study fatigue Lack of technology infrastructure, reporting, and tracking Lack of stakeholder training Lack of technology infrastructure, reporting, and tracking Lack of stakeholder training

8. Case Study: Impact of Optimal Referral Management 18-Aug-15 A Clear Difference 8 Probability of Randomization

9. Who’s Responsibility? Industry Perceptions Sponsors /CROs believe sites have the capacity and expertise to pull through patient referrals CRAs don’t have the time or training to support sites in referral management All PROs have a robust referral management system to ensure tracking and pull through Sites know who, where, and when external referrals are happening 18-Aug-15 A Clear Difference 9

10. How to Address this Issue 18-Aug-15 A Clear Difference 10 Establish Goals Establish Referral Pull Through Benchmarks and Goals Identify Stakeholders Determine stakeholder responsibilitiesInform and Train stakeholders involve Manage Resources Determine where necessary resources will need to be deployed Referral Management Pitfalls Understand referral management limitations in the patient recruitment campaign Patient Recruitment Plan Establish a Referral Management Strategy as part of the Patient Recruitment Plan

11. Referral Management Strategy Assess sites’ interest in receiving external referrals Assess sites’ capacity to manage referral volume Determine volume of referrals based on media funnels, sites’ experience, or required pre- screening volume to reach enrollment objectives Establish a communication and alert plan for outreach initiatives and referral expectations Understand PRO referral management process 18-Aug-15 A Clear Difference 11

12. Identify Possible Pitfalls Identify possible staffing issues Ascertain sites’ capacity to conduct multiple follow-ups to patients Be aware of site fatigue and motivation issues Understand PROs limitations in tracking patient referrals from centralized campaigns 18-Aug-15 A Clear Difference 12

13. Allocate Site Support Resources Leverage site support services that include referral management Incorporate CRAs into the referral management process Determine if “on-the-ground” site support is needed Establish tracking and reporting systems and procedures Deploy “Call-back” Call Center Services 18-Aug-15 A Clear Difference 13

14. Stakeholder Involvement Offer CRA training on patient recruitment and referral management Offer Site Staff training on referral management best practices Schedule rejuvenating meetings with sites Address referral management concerns Determine referral management responsibilities to PRO/CRO/Sponsor/Sites 18-Aug-15 A Clear Difference 14

15. Establish Goals Develop Standard Operating Procedures Establish benchmarks and referral goals Implement centralized or standard localized referral tracking system Use CRAs and PRO referral management services to assess site pull through of patient referrals Establish Key Performance Indicators (KPI) Measure KPIs and address concerns with stakeholders 18-Aug-15 A Clear Difference 15