Historical Data Retrieval in Relation to Screen Failure Rate at Central Rater Call: A Retrospective Comparative Analysis of Three Clinical Trials

Abstract

Research Question: What is the effect of central rater interviews on screen failure rate in clinical trials for major depressive disorder compared to screen failure rate at on-site interview?

Background, Significance, and Rationale for the Question: MDD is one of the most common mental health conditions in the United States. Currently available treatments for MDD are often inadequate, although research into new treatments is ongoing. Clinical trials that investigate new medications to treat MDD often employ central raters to screen candidates in order to increase the internal validity of their study. Central raters remotely evaluate the candidate to determine whether or not they are eligible for the study. Central rater evaluation of MDD severity may differ from on-site evaluation leading to a higher rate of screen failures.

Materials and Methods: Retrospective analysis of the demographics of candidates that failed screening and the reason for their ineligibility in three clinical trials at one clinical site. Historical data retrieval conducted for each person screened. Anticipated

Results, Conclusions, and Impact: We anticipate that screen failures will be higher in clinical trials for major depressive disorder that employ central raters.