The Power of eCOA in Dermatology Clinical Trials

Author: Jill V. Platko PhD, Vice President, Scientific Services 

Snapshot: 

• Fluctuating Symptoms Require Frequent Reporting: Detailed, and often daily, patient reporting helps determine symptom changes throughout complex dermatology trials. 
• Enhancements in Patient Engagement: Patients and caregivers benefit from user-friendly eCOA interfaces, as well as automated alerts and reminders that encourage consistent compliance. 
  

This post is the second in a three-part series exploring how Electronic Clinical Outcome Assessments (eCOA) streamline the clinical trial process and improve data collection in the fields of oncology, dermatology, and gastroenterology. 

In the evolving landscape of clinical trials, technology continues to improve the ways we collect, manage, and analyze data. One impactful advancement has been the adoption of electronic Clinical Outcome Assessments (eCOA). This approach is particularly beneficial in dermatology clinical trials, where precise, daily data collection is essential when determining the efficacy of novel treatments for skin conditions.  
 

Specific Considerations for Dermatology Clinical Trials 

Dermatology addresses a wide range of skin conditions, from chronic diseases like psoriasis and eczema to acute conditions such as acne and dermatitis. These conditions often have symptoms that fluctuate daily, requiring detailed and frequent documentation to determine a drug’s effectiveness in a trial. Additionally, many dermatology patients are children, so questionnaires are often tailored for different ages, such as infants or teenagers, and for younger participants are often completed by caregivers. 

Daily Symptom Tracking is Essential to Dermatology Trials 

Success in a dermatology clinical trial is determined by improvements in patient-reported symptoms, unlike some other types of trials, like oncology, where endpoints are based upon disease progression. This makes accurate and detailed symptom data collection central to a drug’s approval. And, because skin conditions often vary significantly over short periods, frequent – often daily – symptom tracking is essential.  

Trials that use traditional paper-based questionnaires may find patients fill them out retrospectively, such as just before a clinic visit (a dynamic sometimes described as “parking lot syndrome”). This can result in low-quality, incomplete data that may be biased by recall. 

eCOA technology motivates patients to record their symptoms and experiences in a timely manner, providing a more accurate picture of their condition because it captures higher-quality data. Suvoda eCOA can collect key dermatological measures, including daily itch diary data, patient-reported dermatological quality of life responses (like sleep disturbances), clinician-reported body surface area calculations, and eczema severity. eCOA makes it easier for sponsors to then determine improvement trends and tolerability of treatment.  
  

eCOA Can Improve Patient Engagement and Compliance 

eCOA systems are designed with user-friendly interfaces that facilitate easy and regular data entry, encouraging patients to remain engaged with their treatment and the clinical trial. Features such as automated reminders sent to patients can make it easier for them to consistently report their symptoms. Suvoda eCOA also enables email alerts to sites when patients aren’t submitting their data, leading to higher compliance rates. 

Due to the frequency of pediatric patients in dermatology trials, caregivers often complete assessments as observers of the child. Managing caregiver input can be challenging for some eCOA systems, but Suvoda’s platform is designed to handle this with ease by providing unique logins to different respondents, recognizing the importance of accurate and attributable data on patients of all ages for trial outcomes. 

When eCOA is unified with Interactive Response Technology (IRT) on a single platform, the patient journey is streamlined from the very start of the trial. eCOA questionnaires can be completed during the screening process to determine whether a patient is eligible to participate in a study. IRT can then leverage the eCOA data to quickly determine eligible patients for randomization, reducing manual effort for sites.   

Conclusion 

By addressing the unique challenges of dermatological conditions through daily symptom tracking and remote compliance monitoring, eCOA can help enhance data accuracy and patient engagement.  

More than a nice-to-have, embracing eCOA in dermatology is an approach that can improve the quality of data in dermatological clinical trials.  

Author

Jill V. Platko PhD
Vice President,
Scientific Services
Suvoda

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