The pharmaceutical industry is continuously evolving, driven by the imperative to develop more effective and personalized treatments. In this dynamic landscape, electronic Clinical Outcome Assessments (eCOAs) have emerged as a pivotal tool, streamlining data collection and analysis in clinical trials.
While eCOAs offer significant advantages over traditional paper-based methods, CNS-specific eCOAs can be complex and require proven technology and operational delivery that is designed specifically with the impairments found within CNS in mind. This article explores the importance of selecting a CNS specialist organisation when administering CNS-specific eCOAs, and the advantages of having quality assurance tools to save time and money whilst not sacrificing data quality.
Challenges in CNS assessments
CNS conditions encompass a wide range of disorders, from neurodegenerative diseases like Parkinson’s and Alzheimer’s to psychiatric conditions such as depression and schizophrenia. Each of these patient groups faces unique challenges related to their condition, often including difficulties with movement, cognitive function, and mood.
Navigating these challenges is crucial, as they can lead to poor data quality and jeopardize clinical trials.
This is evident in the data, which shows that 85% of Phase II and III CNS trials fail. Even effective interventions can be difficult to detect, partly due to the insensitive and error-prone administration of clinical instruments. Nonetheless, eCOA assessments and their pencil-and-paper counterparts remain the cornerstone of outcome measurement in CNS clinical trials, often serving as the primary endpoint.
Reflecting the complexity of CNS disorders, the instruments designed to assess these conditions are often complex themselves, combining aspects of patient performance with clinician and caregiver reports within a single tool.
For example, the Positive and Negative Syndrome Scale (PANSS) is widely used in clinical trials for schizophrenia and other conditions and is considered the “gold standard” for evaluating the effectiveness of antipsychotic treatments. Unlike many other rating scales, the PANSS includes numerous items and assesses a broad spectrum of symptoms, including positive, negative, neuromotor, and depressive symptoms. It also incorporates data from various sources, such as patient and caregiver reports, as well as clinical observations.
Additionally, the completion of items on the scale is not linear; items are measured and revisited during the interview in varying orders, depending on the flow of the conversation.
These features, and others like them, have significant implications for their deployment in clinical trials, where ensuring data quality is paramount.
The training of raters needs to be consistent and thorough
Ongoing monitoring of administrative quality, through the recording and scoring of interviews, requires technology that supports complex question flows and flexible data capture while ensuring data quality and security.
In addition to the challenges posed by the instruments themselves and the diverse participant groups, the variety of scales and assessments used in CNS trials is extensive, both across and within studies. This complexity makes managing the licensing, translation, and configuration of these scales a significant challenge. Such intricate deployments can impose a substantial burden on studies and increase the risk of delays in study timelines.
When selecting a vendor for CNS eCOA, it’s crucial to consider their experience with CNS scales, efficient study configuration processes, and established relationships with scale license holders.
CNS-specific eCOA technology to optimise time and costs
When implemented with the appropriate level of expertise, CNS-specific eCOAs can provide the necessary sensitivity and specificity for measuring cognitive and neuropsychiatric symptoms.
From an operational standpoint, companies like Cambridge Cognition—one of the longest-running eCOA providers—offer extensive expertise to industry sponsors seeking to incorporate eCOAs into their trials. With approximately 815 pre-configured instruments, they enable rapid and efficient study configurations, ensuring that timelines are met while reducing the burden on sponsors and CROs.
Moreover, selecting a provider with specific CNS experience ensures that instruments are developed with the needs of patients, caregivers, and raters in mind, facilitating the capture of high-quality data with minimal friction.
Quality assurance is also critical in detecting CNS signals in clinical trials, ensuring consistent administration, and minimizing rater errors in complex and subjective assessments. Until now, no scalable, cost-effective solution has existed to minimize errors that could impact trial outcomes.
Automated tools like AQUA, part of Cambridge Cognition’s product portfolio, enhance eCOA delivery for specific instruments. AQUA analyzes audio during the administration of CNS clinical instruments, detecting deviations in administration and scoring to ensure standardized and accurate data, thereby maximizing the likelihood of trial success.
Summary
CNS-specific eCOA solutions represent a significant advancement in clinical trials, offering reduced burden, improved patient engagement, and seamless integration with cognitive assessments. Data from recent years underscores their value in improving data quality, reducing trial timelines, and accelerating the development of new treatments for CNS disorders.
As a leader in this domain, Cambridge Cognition continues to drive innovation and excellence in CNS-specific eCOA solutions, paving the way for more effective and personalised therapies.
