Using Central Ratings to Drive High Quality ClinRO Data

What is a clinician-reported outcome (ClinRO / eClinRO)?

 A clinician-reported outcome (ClinRO) is a report that comes from a trained healthcare professional after observation of a patient’s health condition. A ClinRO measure involves a clinical judgement or interpretation of the observable signs, behaviors, or other physical manifestations thought to be related to a disease or condition. Some ClinROs (also termed clinician ratings) involve complex assessments rating many different facets of a disease in order to derive an overall scoring. 

Central rating and central review: Driving clinical trial data quality and reliability

In complex clinical trials, particularly those involving subjective clinician-reported outcomes (ClinROs, also termed clinician ratings), ensuring consistent and reliable endpoint data is paramount. Two approaches have emerged as powerful solutions: central rating and central review. These methodologies, while distinct, both contribute significantly to improving data quality and reducing variability in clinical assessments.

Both these approaches aim to address threats to ClinRO data quality and the potential to detect treatment-related differences, specifically aiming to reduce variability between raters (inter-rater variability) and even within individual raters over time (intra-rater variability). When site clinicians administer, interpret and score assessment scales differently, it introduces noise into the data that can mask true treatment effects. This variability can lead to reduced statistical power, inflated placebo responses, and rater bias, potentially undermining the ability of the study to make reliable inferences. 

Central rating: Addressing the challenge of rater variability in clinical trials 

Central rating represents a fundamental shift in how clinical assessments are conducted. Instead of relying on site-based raters who may have varying levels of experience with specific scales or conditions, and may introduce unwanted data variability especially for studies with a high number of sites/raters.  Central rating employs a network of highly trained expert clinicians who conduct assessments remotely, typically via video connection. This approach offers several key advantages.

For trials involving treatments with potential functional unblinding characteristics, such as psychedelics, central rating provides the site-independent assessment often required by regulatory authorities. Furthermore, in rare disease studies where specialized clinical expertise may be limited, central rating can broaden access by connecting patients with qualified experts regardless of their geographic location.

The consistency achieved through central rating is particularly valuable in global trials, where cultural and linguistic differences might otherwise introduce variability. With access to a worldwide network of local language clinicians, organizations like Signant Health can ensure standardized, centralized assessment delivery across diverse patient populations.

Central review: Addressing the challenge of rater variability in clinical trials 

While central rating can be used as a replacement for site-based assessments, central review serves as a quality control mechanism for site-conducted evaluations. Expert raters review audio or video recordings of site assessments, evaluating both the administration technique and scoring accuracy. This approach provides several distinct benefits for clinical trial integrity.

Central review allows for early detection of potential issues in assessment administration or scoring, enabling timely intervention and corrective action. This ongoing monitoring helps maintain high data quality throughout the study, rather than discovering issues later during data analysis. For studies where site-based assessments are preferred or required, central review provides a robust quality control mechanism without altering the fundamental assessment approach.

Clinical rater quality control: Continuous monitoring and quality control 

The combination of central rating and central review with supporting solutions and services, such as electronic clinician ratings, rater training and qualification, and blinded data analytics (such as Signant’s leading PureSignal Analytics solution), creates a comprehensive set of tools and services to drive endpoint reliability. This integrated approach helps optimize efficacy signal detection throughout each clinical trial, from start to finish.
By partnering with Signant, an experienced provider offering end-to-end technology solutions and scientific services, sponsors can enhance their ability to generate high-quality evidence while meeting regulatory requirements and maintaining the highest standards of clinical assessment reliability. This comprehensive approach to endpoint quality is increasingly vital in an era of complex clinical trials and evolving regulatory expectations.

Take the next step in optimizing your endpoint data quality: Learn more - Electronic Clinician Ratings (eClinRO) in Clinical Trials: Complete Guide →