Patient Recruitment Strategies

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1 Patient Recruitment Strategies Leveraging Advances in Technology and Data/Software to improve patient and physician recruitment- affordable tools for biotech companies

2 Is the Trial Balloon Rising- YET?

3 The Focus for Today We are calling this a WORKSHOP Share Ways that have worked Find out what We haven t done before Explore some of these tools Patient and Physician Outreach National Enrollment campaigns

4 OK- Let s Set the Baseline Where are we from? Biotech and Pharma Academic/ Community/Private/ Group Clinics CROs/ Other vendors? Do you/site have a patient advocate? Do you utilize EHR Databases and Billing Code? Heat Mapping Tools?

5 The Frustration Within Oncology Trials 28% of US Based Oncology trials enroll on time Only 1-3% of US patients with Cancer participate in clinical trials Drug development delays within the trials are leading to many company s financial strife Hesitation to try new things runs rampant Reluctance to build in strategies upfront is Sponsors dilemma Have you ever heard the following? It is always the CRO s Fault The sites aren t meeting their enrollment projections

6 Challenge We were challenged on how we could find patients, physicians, hospitals and Investigators with AML (orphan indication) Where were the competition doing their studies? Who were they using? How long did it take to enroll? Where should we go for our study Would they have to pay the sites to look at their own database They should get some compensation when patients are enrolled

7 Upfront Country and Investigator Identification Assess Location of AML Studies

8 Too crowded or where the patients are? Active AML Study Sites in Europe

9 SPRI Use of Tools For Accelerating Enrollment AML is a NEEDLE in a HAYSTACK CROs are often challenged with using new tools for faster enrollment Many times- they are told they can t because it costs too much The next tools will show how quickly and easily you can identify global centers and top investigators New data using ICD-9 codes can lead to better physician/site and patient targeting ICD-10 becoming new law in October Matches global standards Tools include- Heat maps, Rx Records,

10 Suggested Investigators Based on History and Current Workload P1 AML

11 Don t stay up at night Fast and easy evaluation Today s Competitive Situation- Head and Neck Cancer Phase 1, 2, and combined phase 1&2 Studies 397 studies are recruiting in the US 140 studies active/not recruiting/or not yet recruiting in US/Europe 128 active not recruiting in the US Today s Situation- Oral Mucositis Phase 1, 2, 3 combined phase 1&2 2&3 Studies 35 studies are recruiting/not yet recruiting globally 20 are being run outside the US without US involvement All studies Phase 1 2 Phase 1&2 2 Phase 2 19 Phase 2&3 2 Phase 3 10

12 Identification and Enrollment Tools

13 Here s what s out there! Physicians and Investigators full contact information Grants, INDs and Dollars awarded to physicians Amount paid by Pharmaceutical companies to MDs Why? Did the MD enroll patients? Does she speak for the Company? Sponsors that each MD did work for Audit information, Referral network, procedures performed at patient level Daily Claims by each physician If you are part of the referral network- there is a chance you can get those patients in YOUR trial

14 SPRI s Tools for Faster Enrollment Examples of ICD 9 Codes for AML Patients by State

15 Targeting the Right Cities

16 Right codes- Right targets AML 28,000 patients

17 So do these patients qualify? MDS Most sites only give us the total numbers

18 Targeting the Right Physicians

19 Moving forward we will need to start reviewing the codes for subjects against inc-excl. or we will contradict the billing database. Since we now know that companies are beginning to look into these types of systems this can make a huge difference

20 Strategies to consider Incorporate tools into early planning Don t focus on Rescue methods Don t just rely on investigator questionnaires for enrollment rates Have sites use their EHRs request the data Use Insurance Claim Data Focus on sites with large patient counts Expect sites to use enrollment outreach Pay for it Hire a CRO for enrollment execution

21 So how can we implement this? Don t have your CRO s Clinical Project Manager do this! It is more involved You will need a different Project Lead focused on utilizing the data and then working with the site team, MSLs, OCNs, Specialty CRAs to develop the referral network, work with advocacy groups, and the Clinical CRO team The person must be considered part of the Project team

22 SPRI Next Steps We are happy to share with you more information on how we perform our trials Our tools and our strategies With SPRI- coming from the Biotech Industry- our results are what is expected Bringing Science, Technology and Patients Together to Promote Health on a Global Scale

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