It is commonly believed that longer lag times between administrations of clinical outcome assessments (COA) are likely to contribute to increased errors.
Typical remedies include rater training such as didactic tutorials, qualification post-tests and scoring of video-based rating precision exercises. These are typically completed before site/study initiation, however, and therefore unlikely to prevent rater drift over time.
Another potential solution includes administration of measures using a tablet device and electronic clinical outcome assessments (eCOA), which has been demonstrated to result in fewer errors than paper and pen administration.
However, there is limited empirical data on the impact of administration lag time on error rates and whether eCOA administration also attenuates the effect of lag time on error rates.
This study investigated the impact of lag time on error rates for commonly used Alzheimer’s disease (AD) COAs, as well as the degree to which administration (eCOA versus paper and pen) attenuated error rates associated with lag time.
- Determine the impact of lag time on error rates of COAs commonly used in AD clinical trials.
- Examine whether use of eCOA versus paper and pen administration attenuates error rates attributable to lag time.
About the Author
Dr. Christopher Randolph is Chief Scientific Officer at MedAvante/Prophase and Clinical Professor of Neurology at Loyola University Medical Center. Dr. Randolph has extensive experience in CNS clinical trials work, as an investigator, consultant and creator and supervisor of rater training programs for a large number of Phase II and Phase III multinational studies in Alzheimer’s disease and other neurodegenerative conditions; schizophrenia; stroke; hepatic encephalopathy; and traumatic brain injury.More Content by Dr. Christopher Randolph, PhD, ABPP-CN | Chief Scientific Officer