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International Clinical Trials

Improving Ratings Precision

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.


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As Regional Manager of United BioSource Corporation’s Prague office, Dr Oto Markovic, MD, is responsible for European investigator services. In this capacity, he directs clinical and project delivery teams that design and implement UBC’s global training programmes. Previously, Oto was the European Medical Communication Lead – EMEA – Global Medical Affairs for Bristol-Myers Squibb. Before that, he worked in clinical development at Eli Lilly on CNS, anti-infective and cardiovascular compounds and served as Deputy Chief of Psychiatry at Horní Berkovice in the Czech Republic. A board-certified psychiatrist at Charles University in Prague, Oto attended medical school at University Komeniana, Slovak Republic.

Rusty Bealer is Director for Information Technology of Investigator Services for UBC. With over 20 years’ experience in this area, he leads the development of applications that track rater training, provide web-based/self-paced training and monitor rater performance throughout clinical trials. Heading a team of software developers and system administrators, he is also responsible for providing the technical infrastructure to support UBC’s internal and external user base. Prior to joining UBC, Rusty held various IT leadership, consulting and development positions with CIGNA Healthcare, HealthAxis and Shared Medical Systems.

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Dr Oto Markovic
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Rusty Bealer
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