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