Typical global phase 3 clinical trials have hundreds of raters at a given time…
A central rating approach for the same trial will have a small group of raters supporting consistent assessment across all participants.
Reduce site and patient burden, speed enrollment, and enhance data quality with centralized rating services from a select cohort of highly trained experts.
In contrast to the traditional approach where raters are dispersed across many clinical research sites, the entire cohort of Cogstate raters can be uniformly and regularly trained and calibrated to increase reliability, standardizations, and scoring accuracy. This approach also allows sites to have rapid access to experienced professionals and allows participants to be assessed from the comfort of their home, reducing the number of site visits–supporting faster and more diverse recruitment.
Central rating can take place while participants are at home or visiting the site/clinic. Whether your clinical trial is fully decentralized with all assessments administered remotely, or a hybrid scenario with both in-clinic and at-home activities, the central rating approach can be customized to meet the unique trial objectives and requirements of the protocol.
Enhanced data quality via reduced data variance and from a small pool of highly qualified and experienced raters who undergo intensive rater training and monitoring
Optimized enrollment and retention of more diverse populations via patient-centric trial designs
Rapid site readiness by removing the bottleneck of identifying highly specialized raters to administer complex cognitive assessments
Cogstate’s team includes a network of more than 175 clinicians and scientists who are highly trained in the areas of psychology, neuropsychology, psychiatry, and neurology. These professionals support central rating, rater training, and central monitoring programs around the world in 40+ languages.
Central rater qualification and training requirements are robust, ensuring quality outcomes and reducing risk for clinical trial teams. Central raters must have graduate-level education in a related field, extensive hands-on experience with cognitive and behavioral scale administration, and clinical experience with the indication and patient population.
Central raters are thoroughly trained and calibrated with multiple practice opportunities, often culminating in an applied demonstration of proficiency with a member of Cogstate’s senior science leadership team. Central raters undergo close performance surveillance and regular recalibration to reduce rater drift. In addition, operational training on workflows, electronic platforms, and telehealth modalities is provided.
The Vineland-3 is a widely used measure of adaptive functioning in rare disease clinical trials. In one program of clinical trials, 53 site raters administered the assessment; in another program of clinical trials, 7 central raters administered the assessment. An analysis of these results showed the use of central raters offered greater efficiency and optimized data quality by decreasing rater variance, while also reducing the burden on sites.
Scoring of many clinical outcome measures can be highly manual, complex, time intensive, and error prone. In a central scoring model, assessments are completed by site raters either in-clinic or via telephone or videoconference. Cogstate expert raters then score the assessments. Utilization of experts for centralized scoring (or score validation) can dramatically improve scoring accuracy and reduce variance, thus improving data quality.
As more clinical trials realize the potential of decentralization, Cogstate digital endpoints are enabling at-home, self-administered assessment and our remote rating services are enabling at-home clinician-administered assessment to drive both enhanced data quality as well as patient enrollment, engagement and retention.
SEE HOW WE CAN SUPPORT YOUR FULLY REMOTE OR HYBRID TRIAL DELIVERY
Cogstate’s clinical trial services, coupled with innovative operational approaches, advanced analytics, and scientific consulting, help research teams draw conclusions from study data faster and with more accuracy. Learn how we can support your study: