Clinical Training And Assessment Group Improves Data Validity; Yields Only Positive Pivotal Study

A sponsor was conducting two parallel panic disorder studies to assess the efficacy of an antidepressant across 95 sites throughout Europe. INC Research/inVentiv Health was selected as a full-service CRO for one pivotal study, while a separate CRO was chosen for the parallel study. Additionally, the Clinical Training and Assessment (CTA) group was provided ratertraining services for both of these studies. The trials, which randomized 625 patients over a12-month enrollment period, surpassed all contracted milestones. However, a routine interim data analysis revealed a very serious problem with data in the study conducted by the other CRO that was not apparent in the INC Research/inVentiv Health data set. 

By maximizing inter-rater reliability, the CTA group can help to generate data that is sensitive enough to see drug effects if they truly exist. The rater training program for this study consisted of training at a series of investigator meetings and for new raters throughout the studies on the Mini Neuropsychiatric Interview, Panic and Anticipatory Anxiety Scale (a patient diary) and the Panic Disorder Severity Scale (a semi-structured interview). In addition to the didactic slide presentations, INC Research/inVentiv Health produced patient interview videotapes for training and certification on the PDSS, as well as a videotape demonstrating how to instruct patients on filling out the diary.