Subject attrition from randomized Schizophrenia trials is a significant problem and has been found in a meta-analysis to be as high as 76%. The problem of drop-out is sometimes not addressed until the statistical analysis stage of a study which can decrease the validity of the results increasing the likelihood of a failed trial. The authors previously examined the effect of 9 trial design variables on individual completion in 11 Phase I trials in subjects with stable Schizophrenia or Schizoaffective Disorder at two clinical research sites in the period from 2009 to 2014 (Krefetz et al, 2015) The analysis showed that shortening the length of the inpatient period, increasing the outpatient period, and shortening the longest period between outpatient visits had a positive impact on completion.
Successes in Phase II Autologous Cellular Therapy Oncology Program
A case study describing two Phase II, multicenter studies assessing the efficacy and safety of an autologous cellular therapy treatment.
ECG Assessments During the Development of Oncology Compounds
Single-center oncology studies performed by dedicated PRA staff, combined with the High Precision QT approach of iCardiac, generates conclusive ECG…
Real-World Misuse Abuse and Dependence of Abuse Deterrent
Abuse deterrent formulations of opioid medications (ADOs) may help curtail the widespread abuse, misuse, and diversion of these products.With the…