The 4th Annual Clinical Operations in Oncology Trials East Coast was an amazing hit. Over 25 speakers challenged the 200 attendees on how- "WE" as an industry can use new tools and strategies to better our Clinical Trial Execution and Patient Enrollment. With only 3% of the patients in the USA participating in Cancer Trials- we have to do a better job finding ways to educate them about the benefits of clinical studies. The following tools are some of the new enhancements for better site and physician selection which can help find better results.

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

2. Is Your Trial
Enrollment Rising?

3. The Focus for Today
• Demonstrating how new tools can work
and be utilized for better execution
• Share Ways that have worked to enroll
trials faster and cheaper than extending
enrollment
• Discuss how the industry implements the
execution of these programs
• Discuss how we can share this info with
the sites

4. OK- Let‘s Set the Baseline
Have you used the following tools?
• Do you/site have a patient advocate?
• Do you utilize EHR Databases
• Billing Code?
• Heat Mapping Tools?
• Do you share these tools with the
Investigators?

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
– Utilizing these tools has led to a 14 – 19% Patient
participation in Cancer studies in the UK.
• Hesitation to try new things runs rampant
• Sponsor’s Dilemma -Reluctance to build in strategies
upfront
• Have you ever heard the following?
– “It is always the CRO’s Fault”
– The sites aren’t meeting their enrollment projections”
The Goal is to improve on these

6. SPRI’s Challenge
• We were challenged on how we could find
patients, physicians, hospitals and
Investigators with AML (orphan indication)
– Where are the competing studies?
– What sites are/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?

7. Assess Location of AML Studies
Upfront Country and
Investigator Identification

8. Too Crowded?
Too Many Patients?
Active AML Study Sites in Europe

9. SPRI Use of Tools
For Accelerating Enrollment
• AML is a “NEEDLE in a HAYSTACK”
• CROs are challenged with using new tools for faster enrollment
• Many times- they are told they can’t because “it costs too much”
• 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, medical records(MX) and
hospital records(HX) records

10. Detailed BioPharm Data
Phase 1- AML Information
Evaluation Tools of Sites and Results

11. Don’t stay up at night
Fast and easy evaluation
Today’s Competitive Situation- Head and Neck Cancer
• 293 total studies ongoing globally
• 170 studies are recruiting in the US
• 317 studies combining H and N and Mucositis
Today’s Situation- Oral Mucositis
Phase 1, 2, 3
12 months ago 35 studies were recruiting/not yet recruiting globally
Now 51 studies are recruiting or not yet recruiting globally

12. Physician 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. Filtering Down to AML

15. Right codes- Right targets
AML 28,000* Patients

16. Tools for Faster Enrollment
AML Patients Nationwide

17. Examples of ICD-9 Codes for
AML Patients by State (FL)

18. Targeting the Right Cities

19. Targeting the Right
Physicians

20. So Do These Patients
Qualify? Indication-MDS
• Most sites only give us “the total numbers”

21. Strategies to implement
Now
• 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

22. 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

23. SPRI Offers and Next
Steps
• We are happy to share with you more
information on how we perform our trials
– Our tools and our strategies
• We are happy to perform stand-alone
global feasibility services
• Then perform site selection and study start
up

24. SPRI’s DNA
Enrolling Global Studies
On Time
Bringing Science, Technology and
Patients together to Promote Health
on a Global Scale