Why work with a CNS-specific eCOA provider?

Interviewer: When considering an eCOA solution, what key functions should it provide, particularly for CNS trials?

Chief Scientist: When thinking about an eCOA solution for CNS trials, it needs to do everything a classic eCOA solution does: provide automated, efficient, secure, and scalable data collection.

This reduces the burden on both sites and the process of data collection. However, CNS conditions introduce additional complications beyond standard symptom scales.

Firstly, many CNS scales can be complex. For example, clinician-reported outcomes often have nonlinear administration. In the PANSS scale, for instance, clinicians may need to skip between sections based on how patients present and respond. Functionality like image capture is often also needed. 

Additionally, CNS trials often require the additional collection of performance outcomes, such as measures of cognition, attention, and memory— important elements for in many therapeutic areas. Our platform's ability to smoothly capture both these types of data on a single platform without the need for different technologies or logins improves the patient, site, and rater experience while reducing burdens overall. 

Interviewer: Which neurological conditions or cognitive impairments is your platform particularly suited for?

Chief Scientist: Much of our experience has been in neurodegenerative diseases, where we provide digital cognitive assessments, or performance outcomes, alongside conventional endpoints in clinical trials.

We’ve also done significant work in depression, where we've been able to collect outcome measures at high frequency, administering brief depression scales daily or weekly on a range of devices.

This reduces the friction associated with data collection and minimizes recall bias. When patients with depression are asked to think back over a month or even two weeks, their negative bias can skew their reporting. However, capturing symptoms more frequently brings the data closer to real-time, reducing this source of bias. 

Interviewer: How customizable is your CNS-specific platform?

Chief Scientist: Our platform is highly customizable to meet protocol changes and specific study needs. One of the key areas we focus on is the patient experience and engagement. When we're collecting data from patients with psychiatric conditions, especially remotely, ease of use becomes incredibly important. We want to reduce barriers to participation and have the experience to help sponsors achieve this. 

A common concern is poor compliance with e-scales or questionnaires in psychiatric patients, particularly when data is collected remotely. However, our data shows otherwise.

We’ve seen adherence rates above 80%, even with intensive data collection schedules, such as daily assessments. This suggests that if the usability and user experience are right, we can reliably and robustly collect data. 

Interviewer: What other considerations are important when deploying this technology in clinical trials?

Chief Scientist: There are a couple of fundamental concerns in clinical trials. From a sponsor’s perspective the robustness of the technology is key — can it capture data without data loss?

Our cloud-based system is designed to minimize data loss, allowing offline functionality and ensuring secure, consistent data syncing. It's supported by strong data security and quality systems, ensuring the integrity of the data we collect. 

From a site perspective, data capture technology needs to decrease, rather than increase, the burden of data collection. The maturity and responsiveness of the vendor clinical project management team supporting the study is also something we pride ourselves on – we continuously collect data from sites and sponsors to ensure we are doing the right thing and can respond to changes and queries in a timely way.  

Fundamentally though, the success of any trial requires that the correct choices are made at the design stage – measuring the right thing a the right cadence to pick up the desired signal. We have a really strong science team which has a great deal of experience in supporting studies and working in partnership with our clients to help get this right.  

Visit www.cambridgecognition.com/5-reasons-why-cns-specific-ecoa-providers-accelerate-your-clinical-trial for more information. Or download out free eCOA specific guide below.