Data Quality Monitoring in Clinical Trials
This paper summarizes the results of the CNS Summit Data Quality Monitoring Workgroup
analysis of current data quality monitoring techniques used in central nervous system
(CNS) clinical trials. Based on audience polls conducted at the CNS Summit, the
panel determined that current techniques used to monitor data and quality in clinical
trials are broad, uncontrolled, and lack independent verification. Case examples
of current data quality methodology are presented and discussed. Perspectives of
pharmaceutical companies and trial sites regarding data quality monitoring are presented.
Potential future developments in CNS data quality monitoring are described. Increased
utilization of biomarkers as objective outcomes and for patient selection is considered
to be the most impactful development in data quality monitoring over the next 10
years. Additional future outcome measures and patient selection approaches are discussed.
Rater Training Guidance
Individuals with a wide range of skill and training routinely administer rating
scales used in clinical neuroscience research studies. The training and certification
methodologies used in clinical trials vary in their level of rigor. There is currently
no accepted standard for the clinical research industry to follow when selecting
and training raters to administer rating scales. Such scales are used as primary
and secondary outcome measures contributing to the registration of investigational
drugs and/or for empirical studies published in peer-reviewed journal articles.Studies
such as these would be better served by an industry-wide guideline.
The purpose of the Rater Training and Certification Recommendations document is
to define terminology and to propose general process recommendations for training,
qualification and certification of raters on clinician-rated scales commonly used
in neuroscience clinical research. These recommendations are intended to provide
a common framework for clinical trial investigators, pharmaceutical companies, contract
research organizations, and other entities to follow, providing a standardized baseline
approach for selecting, training and evaluating raters.