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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
What do you think when you hear
"Clinical Trial"?
Prevalence of IBD
1.6 million Adult Patients
80,000 Pediatric Patients
1500+ Clinical Trials available for IBD
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
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
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.
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
Overcoming Challenges
Industry
Silos
PARADIGM SHIFT
Community
Providers
Patients Researchers
Industry
Providers Patients
Researchers Industry
CCFA
CCFA
Clinical Trials Community
Accelerate clinical trial recruitment
Raise
Awareness
Provide
Education
Offer
Support
Awareness Campaign
Increase awareness of clinical trials and benefits
Inform patients / providers of local opportunities
Direct patients / providers to our community resources
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
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
Clinical Trial Community
Empower Patients
Promote Clinical Trial Awareness
Strengthen Support
Community
Faster Enrollment & Research
Progress