Tools to Drive Enrollment OCT Arena-Boston-2015

Patient Recruitment Strategies

Leveraging Advances in Technology and Data/Software to improve patient and physician recruitment- affordable

tools for biotech companies

Is Your Trial Enrollment Rising?

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

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?

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

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?

Assess Location of AML Studies

Upfront Country and Investigator Identification

Too Crowded? Too Many Patients?

Active AML Study Sites in Europe

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

Detailed BioPharm Data

Phase 1- AML InformationEvaluation Tools of Sites and Results

Don’t stay up at nightFast and easy evaluationToday’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 MucositisPhase 1, 2, 312 months ago 35 studies were recruiting/not yet recruiting globallyNow 51 studies are recruiting or not yet recruiting globally

Physician Identification and Enrollment Tools

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

Filtering Down to AML

Right codes- Right targets AML 28,000* Patients

Tools for Faster EnrollmentAML Patients Nationwide

Examples of ICD-9 Codes for

AML Patients by State (FL)

Targeting the Right Cities

Targeting the Right Physicians

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

numbers”

Strategies to implementNow• 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

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

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

SPRI’s DNA

Enrolling Global Studies On Time

Bringing Science, Technology and Patients together to Promote Health

on a Global Scale