Endpoint Data Quality: Improving Rater Training and Certification

Endpoint Data Quality

Cogstate designs and delivers risk-based data quality programs that combine an understanding of your trial objectives with our knowledge of assessments and common rater error patterns.

From helping you establish rater qualification criteria, to tailored certification pathways that credit the experience of expert raters, to central monitoring programs that target clinician reviews where they’re needed most. We welcome the opportunity to earn trusted partner relationships with your team.

Endpoint Data Quality Programs Tailored to Your Trial

Rater training to reduce burden and ensure quality

Traditional rater training is often redundant and burdensome. Cogstate has created a rater qualification, instruction, and management program that prepares raters to administer scales to the highest standards while eliminating unnecessary training.

Our approach is informed by a deep understanding of raters’ limitations and errors patterns. We customize trainings based on raters’ experience, thus minimizing burden, and allowing for expedited study start-up.

Central monitoring to safeguard data quality of important endpoints

Central monitoring is the process of identifying rater errors and preventing them from detrimentally impacting study quality. This can include tasks such as sampling source documentation or audio recordings of assessments to identify and correct errors.

Cogstate regularly executes strategic, risk-based central rater and data monitoring programs and can help develop a tailored approach to increase the reliability and validity of important clinical measures in your trial.

Global network of clinical and scientific experts to ensure endpoint data quality

Cogstate coordinates a global network of experts in the areas of psychology, neuropsychology, psychiatry, and neurology who remotely support global biopharmaceutical research. These experts ensure quality clinical assessments of cognition, mood, behavior, neurodevelopment, and motor function.

Currently the network consists of 180 professionals speaking 40 languages.

Scale management coordinated by experts

Selecting, acquiring, and translating the appropriate scales is a meticulous process that can have dramatic impacts on the time, cost, and quality of a trial.

Cogstate’s scale management team has extensive experience and collaborative relationships with license holders, translation companies, and other key partners to help you achieve accurate and timely delivery.

Case Examples of Data Quality Programs in Action

Site Raters Report Highly Positive Alzheimer’s Assessment Training from Cogstate Clinical Expert Coaches

Cogstate sent a survey to 261 English speaking raters trained by Cogstate clinical expert coaches to administer complex Alzheimer’s assessments. 48 individuals responded and gave overwhelmingly positive reviews, with questions on coaches’ competency and feedback receiving 100% positive (Strongly Agree/Agree) responses. (Wacker, et al, “Rater Perspectives on Applied Training of Cognitive Clinical Outcome Assessments, Delivered by Neuropsychology Experts,” AAIC 2022).

Programmatic Rater Training Led to Efficiencies and Maintained Quality

Cogstate worked with a sponsor team to develop rater training across a program with multiple rare disease trials. Raters were trained and then given the opportunity to participate across four trials all leveraging the same scale. This led to tremendous efficiencies, as nearly half of the raters participated in two or more studies, reducing the individual training burden by 25%. In addition, only 7% of scale administrations had errors that required follow-up, showing the programmatic approach to training provided reliable data capture. (Ventola, et al, “Rater academy: increasing efficiency in training clinicians within rare disease trials.” NORD, 2021)

Central Raters Optimized Data Quality via Decreased Rater Variance

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. (Ventola, et al, “Leveraging Remote Assessment and Central Raters to Optimize Data Quality in Rare Neurodevelopment Disorders Clinical Trials,” ECRD, 2022)

The team of 7 central raters conducted 150 administrations (~21 per person) compared to the 53 site raters who conducted 138 administrations (~2.5 per person).
0 of the administrations completed by the central raters had significant errors, compared to the site raters which had 4 administrations with errors that compromised the validity of the assessment.

Learn more about Central Rating

Streamlined eCOA partnerships for seamless data capture

eCOA systems allow for digitally capturing study data with pre-set workflows, real-time edit checks, and algorithmic flags to improve data accuracy. Cogstate partners with industry leading eCOA providers to deliver enhanced tablet-based scales and web-based eSource solutions, combining a user-friendly interface with a secure and reliable data management platform.

Regulatory Compliant

Cogstate has developed unique systems to provide sophisticated and secure training and rater tracking (Cogstate Instructor™), as well as data management and monitoring (DataPoint®). Cogstate systems meet all relevant regulatory requirements for security and integrity of data in clinical trials, including 21 CFR Part 11. The support procedures meet GCP guidelines.