Case Study

Immuno-Inflammation Clinical Trials: Challenges And Solutions

Source: Kayentis

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
access the Case Study!

Get unlimited access to:

Trend and Thought Leadership Articles
Case Studies & White Papers
Extensive Product Database
Members-Only Premium Content
Welcome Back! Please Log In to Continue. X

Enter your credentials below to log in. Not yet a member of Clinical Leader? Subscribe today.

Subscribe to Clinical Leader X

Please enter your email address and create a password to access the full content, Or log in to your account to continue.


Subscribe to Clinical Leader