| Designing and implementing an optimal ratings surveillance system, explain Oto Markovic and Rusty Bealer of United BioSource Corporation, will help sponsors get higher quality data
Clinical trials frequently rely on subjective clinician-rated outcomes as pivotal endpoints. The scoring of these assessments is often based on clinical subjectivity and individual interpretation, which can increase variability across sites and raters – potentially contributing to failed or inconclusive studies.
The use of electronic tools can assist in reinforcing the continuing reliability of data collected using clinician-rated outcomes. Real-time ratings surveillance systems are an important new tool for monitoring these data. Moreover, there is some indication that the FDA and EMEA are considering guidance to the industry addressing how clinical trial sponsors should incorporate subjective endpoints in their studies.
This article will examine how these systems can be designed and deployed in support of clinical trials that will rely on these subjective endpoints. Specifically, we will examine techniques for:
- Improving the competency of the clinician-rater
- Ensuring greater consistency of data collection
- Setting up surveillance systems for optimal results
IMPROVING THE COMPETENCY OF CLINICIAN-RATERS
Subjective endpoints are included in virtually all central nervous system (CNS) clinical trials, as well as in many trials in other disease areas such as oncology, pulmonology, gastroenterology, dermatology, urology and gynaecology. As a result, it is important to improve the competency of the data collection ‘vehicle’ – in this case, the clinician-rater.
Certainly, rater training and certification (RTC) is an essential component in developing the ‘best raters’ for a study, since it provides the basis for obtaining initial interrater reliability across raters and intra-rater reliability within raters (1). However, rater training prior to study initiation does not guarantee sustained ratings quality and reliability in-study. |
