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Factors affecting Clinical Trial Interest and Enrollment in IBD patients
S. Alandra Weaver, MPH
Director, Quality of Care and Clinical Research Programs Crohn's & Colitis Foundation of America
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What do you think when you hear
"Clinical Trial"?
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Prevalence of IBD
1.6 million Adult Patients
80,000 Pediatric Patients
1500+ Clinical Trials available for IBD
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Barriers to Patient Awareness / Participation
• Negative perception of clinical trials
• Lack of exposure or knowledge of relevant trials
• Fear of negative side effects / Drug
ineffectiveness / Receiving a placebo
• Life interference: Time commitment, Burden,
Travel costs
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Barriers to Physician Awareness / Participation
• Lack of awareness of actively enrolling / relevant trials
• Reluctance to transfer care to another provider
• Lack of communication skills necessary to describe
the protocol and clinical trial process to patients
• Lack of time to present the information or participate
in the clinical trial
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My (Smartphone) Doctor
FIG U R E 9 .4: Doctors are getting squeezed like never before.
Excerpt – Topol, Eric. The Patient Will See You Now: The Future of Medicine is in Your Hands. New York, NY: Basic Books, 2015;
page 177.
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Challenges in Trial Enrollment
References: 1. Roan, S. Medical clinical research slows for lack of patients. Los Angeles Times. March 14, 2009. Accessed at: http://articles.latimes.com/2009/mar/14/science/sci-clinical-
trials14 2. Getz KA. Enrollment Performance: Weighing the "Facts". Applied Clinical Trials. Volume 21, Issue 5. Accessed at: http://www.appliedclinicaltrialsonline.com/enrollment-
performance-weighing-facts?id=&sk=&date=&pageID=2 3. Miletello, G. Immunotherapy Clinical Trials in Melanoma: Insights for Overcoming Patient Recruitment Challenges. Applied Clinical Trials. April 24, 2014. Accessed at:
http://www.appliedclinicaltrialsonline.com/immunotherapy-clinical-trials-melanoma-insights-overcoming-patient-recruitment-challenges
Lack of Awareness
Poor Understanding
Challenges in
Enrollment
Only 6% of doctors suggest trials to
their patients
40% of adults lack basic understanding of trials
48% of trials under-enroll
6% of trials finish on time
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Overcoming Challenges
Industry
Silos
PARADIGM SHIFT
Community
Providers
Patients Researchers
Industry
Providers Patients
Researchers Industry
CCFA
CCFA
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Clinical Trials Community
Accelerate clinical trial recruitment
Raise
Awareness
Provide
Education
Offer
Support
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Awareness Campaign
Increase awareness of clinical trials and benefits
Inform patients / providers of local opportunities
Direct patients / providers to our community resources
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Shift conversation
? What is a clinical trial?
Why should I enroll in a trial?
How do I find a trial?
When do I start considering a trial?
How do I know which trial is right for me?
! Hey Doc! Here are the trials I am interested in, let’s talk?
Education Campaign
Knowledge Fear
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Build support network: • Help patients navigate the clinical trial
landscape
• Find trials that are appropriate for them
• Provide patients with support resources to increase their comfort level with clinical trials
Support Campaign
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Clinical Trial Community
Empower Patients
Promote Clinical Trial Awareness
Strengthen Support
Community
Faster Enrollment & Research
Progress
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