The Challenge of Patient-Reported Data in IBD Clinical Trials
Clinical trials have played a crucial role in developing new treatments for inflammatory bowel disease (IBD), including both Crohn's disease (CD) and ulcerative colitis (UC). These chronic conditions affect millions worldwide, causing symptoms that significantly impact quality of life.
For these trials to accurately assess treatment effectiveness, patients must regularly report their symptoms. The FDA recommends using specific assessment tools1,2: the Crohn's Disease Activity Index (CDAI) for CD trials and the modified Mayo Score (mMS) for UC trials. Both require patients to complete daily diaries tracking critical symptoms like:
- Stool frequency
- Rectal bleeding
- Abdominal pain
- General well-being
But how do we ensure patients consistently complete these diaries? One common approach is implementing electronic reminders and alarms on the devices patients use to record their symptoms. But just how effective are these reminders?
Our Research Approach
To answer this question, our team conducted a comprehensive analysis examining over 3.7 million electronic diary (eDiary) entries from 12,153 patients across 11 different IBD clinical trials.
Patients in these studies used either their personal smartphones or provisioned devices to complete daily eDiaries throughout their participation. Each device was programmed with notifications and alarms to remind patients when it was time to complete their entries.
For our analysis, we measured the difference between when the alarm occurred and when patients actually opened their eDiary application to complete their entries.
What We Discovered
Crohn's Disease Patients
- 65% of all eDiaries were opened after the programmed alarm time
- 39% were answered within 30 minutes of the alarm
- 8% were answered between 30 minutes and one hour after the alarm
- This means nearly half (47%) of all diary entries were completed within one hour of the alarm
Ulcerative Colitis Patients
- 60% of eDiaries were opened after the programmed alarm time
- 38% were answered within 30 minutes of the alarm
- 8% were answered between 30 minutes and one hour after the alarm
- Similar to CD patients, 46% of UC patient diary entries were completed within one hour of the alarm
What This Means for Clinical Trials
Our findings suggest that eDiary alarms can help improve patient compliance with daily symptom reporting. The data shows that alarms encourage a significant portion of patients to complete their diary entries within an hour of receiving the reminder.
This is particularly important in IBD clinical trials, where accurate and timely symptom reporting directly impacts the validity of trial outcomes. Missing or delayed entries could potentially skew results and affect our understanding of treatment efficacy.
Beyond Alarms: The Importance of Patient Education
While our research demonstrates that alarms play a valuable role in improving diary completion rates, technology alone isn't enough. The data also suggests that additional factors influence patient compliance.
Study teams and clinical sites should continue emphasizing patient education about the importance of consistent diary completion. Helping patients understand how their daily entries contribute to the overall success of the trial—and potentially to the development of new treatments—remains a crucial component of any successful IBD clinical trial.
Next Steps
As digital tools continue to evolve in clinical research, further investigation into optimizing patient engagement strategies could yield even better compliance rates. Combining thoughtful reminder systems with comprehensive patient education may provide the best approach for ensuring high-quality patient-reported outcomes in IBD research.
About the authors
Maria Visser, PhD is a Clinical Scientist at Signant Health, specializing in Phase 3-4 dermatology clinical trials, with a focus on atopic dermatitis, pruritis, and vitiligo. With a Ph.D. in Physiological Sciences and a background in clinical research, Maria leverages their analytical and critical thinking skills to solve complex problems. Known for their effective interpersonal communication, they engage seamlessly with both internal and external stakeholders.
Branden Kusanto, PhD is a Clinical Scientist in Digital Health & eCOA Science at Signant Health. He specializes in eCOA, eConsent, and multiple therapeutic areas like, dermatology, gastroenterology, pediatrics, and rare diseases. Dr. Kusanto studied bioengineering at Oregon State University before completing his PhD in platelet biology at Hull York Medical School.
Todd Everhart, MD, FACP, is the internal medicine leader at Signant. Dr. Everhart is board-certified in internal medicine and a fellow of the American College of Physicians with over 23 years of experience in the practice of medicine and over 12 years of experience in clinical development. Prior to joining Signant, Dr. Everhart held positions of Vice President, Medical Affairs and Vice President, Medical Informatics at Chiltern and Covance, and consulted independently in the areas of medical monitoring, medical data review, data analytics, and physician adoption of technology. He has worked in all phases of clinical development in numerous therapeutic areas including allergy & immunology, cardiovascular, hematology & oncology, infectious disease & HIV, neurology, ophthalmology, psychiatry, respiratory, and rheumatology.
References
- U.S. Food and Drug Administration (FDA). Ulcerative Colitis: Developing Drugs for Treatment. Guidance for Industry. April 2022. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/ulcerative-colitis-developing-drugs-treatment. Accessed 15 Nov 2024.
- U.S. Food and Drug Administration (FDA). Crohn’s Disease: Developing Drugs for Treatment. Guidance for Industry. April 2022. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/crohns-disease-developing-drugs-treatment. Accessed 15 Nov 2024.
