Clinical Trial Patient Recruitment Strategies for Sponsors and CROs

1. Patient Recruitment
Strategies
Kunal Sampat, MNA, ACRP-CP
April 2019

2. Why Clinical Trials Need To Enroll Faster?
• The sooner you can complete trial enrollment, the faster the medical product can
help those in medical need
• This is a real problem that the industry is facing and it doesn’t seem to go away
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3. #1 Loosen your protocol inclusion/exclusion criteria
• Academic research does not equal medical practice
• Study PI feedback is one person’s opinion/ view
• You can consider having a steering committee, especially needed for
multidisciplinary studies
• Identify criteria that has causing you to lose the most number of patient
• Stay laser focused on your study endpoints, specifically the primary endpoint
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4. #2 Eliminate or reduce the number of non-standard of care
assessments
• Eliminate nice-to-have tests that time consuming and difficult for research to
execute and/or patients to undergo
• Constantly get feedback from your sites and update the table to assessments
• Stay laser focused on your study endpoints, specifically the primary endpoint,
eliminate the rest
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5. #3 Educate and engage referral physicians
• We live in a noisy world
• Connect with referring physicians
• Have your research assistant create a spreadsheet with names and contact
information of referring physicians, then call them one by one
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6. #4 Speak at professional congress and request for referrals
• Posters or presentations at local congresses
• If you are busy, have a fellow travel to the congress, it’s great learning opportunity
for him/her
• Share your work, share progress. Physicians love data
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7. #5 Write emails or send letters to professional colleagues
• Create a referring physician email or letter template
• Ensure clear messaging
• Keep it one page, enclose trial brochure
• Hire administrative/research assistant
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8. #6 Share trial information
• Create a study poster and post it in the lunchroom or lab area where there is high
traffic of physicians
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9. #7 Advertise on your website
• Hospital have a section advertising clinical trials
• There are also TV monitors in patient areas where you can share trial related
information
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10. #8 Reach out to patients directly via social media groups
• There are Facebook groups with patients undergoing or needing treatment
options you’re offering
• Create a landing page (website) with relevant trial information. Ensure website
content is approved by IRB/Ethics Committee and regulatory body (ex: FDA)
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11. #9 Add more sites to the study
• Increase your chances of hitting your enrollment goal/ completing enrollment on
time
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12. #10 Hire a recruitment consultant with relevant experience
• Write down criteria of what you expect from this person, what type of experience/
skills do you want them to bring to the table
• Remember whoever you hire, this person should work well with your team and
provide tremendous value to your organization
• The consultant should be willing to get their hands dirty
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13. #11 Conduct additional medical chart reviews and/or pharmacy
records
• Depending on your inclusion/ exclusion criteria, you can work backward and do a
retrospective chart review to identify potential patients
• Have the nurse contact these patient, ensure you comply with your IRB/ Ethics
Committee procedures
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14. #12 Develop an action plan to reduce patient screen failure
• Carefully review and categorize screen failure reports
• Understand the highest reasons for screen failures and determine how you can
turn your screen failures into actual patients (example: loosening
inclusion/exclusion criteria)
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15. #13 Create screening and enrollment (recruitment) workflow
• Every participating clinical trial can benefit from enrollment plan
• Map out every step from patient screening to enrollment and follow-up
• Who communicates with whom and when
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16. #14 Implement a continuation protocol
• From a patient standpoint, a continuation protocol may be valuable if the medical
product is not available commercially and the patient needs the medical product
after the patient has completed the trial
• From a physician standpoint, a continuation protocol gives physicians an
opportunity to provide their patients with treatment while regulatory approval of
the medical product is pending
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17. #15 Conduct investigator and coordinator meetings at local
congresses
• Share trial status and/or results with investigators and research coordinators who
are attending medical congresses
• Use this time to remind sites key opportunities, challenges and enrollment tools
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18. #16 Create and distribute enrollment tools
• First, start with what tools such as protocol inclusion/ exclusion cards, patient
brochures, posters, etc. are most beneficial to your sites.
• Then pick one. Don’t try to create all tools at the same time
• Hire a graphics designer, find a printer and share these enrollment tools the
research staff
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19. #17 Share the enrollment process of high enrolling clinical trial
sites
• Schedule a webinar with participating trial sites
• Reach out to high enrolling sites and ask them if they would be willing to share
their patient recruitment experience and success strategies
• Sponsors should talk less, sites should be talking more
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20. THANK
YOU
clinicaltrialpodcast.com
Kunal Sampat
kunal@clinicaltrialpodcast.com