Immuno-Inflammation Clinical Trials: Challenges And Solutions

Challenges of immunology/inflammation studies:

Complex eCOA Build

• Questionnaires are often long and contain numerous questions and domains
• Body maps are frequent, which generate design complexities
• Questionnaires are very often associated with score calculations, which adds programming challenges
• eDiaries are collected daily over a long period (up to 60 weeks), robust eDiary design and strict compliance are critical to success

Key Site Staff Role During The Study Progress

• Immuno- inflammation trials frequently require measures of biological parameters or results of exams reported by the study site
• Scores based on both the patient’s diary and site visit data require input from the study site staff, strong support, and reliable programming from the eCOA vendor
• Sites need to fill in the patient information data and results in a timely manner, as this can trigger follow-up actions and scheduling of the next study visits

Long Study Duration And Patients In Pain

• Immuno-inflammation studies can last several years, and with long-lasting studies comes the risk of losing compliance and patient engagement. The engagement of sites can also become at risk
• Patients are exposed to acute inflammation and pain crises which can have an impact on patients’ day-to-day lives and make the completion of questionnaires very difficult