In the evolving landscape of clinical research, remote clinical trials represent a spectrum of methodologies, ranging from visiting nurse models to entirely unsupervised assessments where participants engage independently in their own environments. This diversity in approach addresses the varied requirements of different study populations and reflects the adaptability of modern clinical research methodologies.
In the context of unsupervised, remote assessments, participants have the flexibility to complete tasks at their convenience in settings familiar to them. Where feasible to apply, this approach may significantly reduce barriers to trial entry, facilitating broader participation and enhancing the inclusivity of clinical research.
While the premise sounds great, what do the results of the model look like? Can these types of approaches successfully be used for clinical studies?
High Completion and Low Error Rates from Remote Testing in The Healthy Brain Project
1,594 participants engaged in unsupervised assessments using the Cogstate Brief Battery (CBB) as part of the Health Brain Project. Participants accessed the CBB via a web-based platform from a desktop or laptop device, at their leisure.
Researchers examined acceptability, usability, and validity of the CBB in a remote, unsupervised format:
- Acceptability was assessed based on the amount of missing data, with the study achieving a 98% completion rate, indicating high participant engagement and data completeness, something important to regulators.
- Usability was evaluated by examining the error rates in test performance and the learnability of the tasks, as determined by the time taken to read instructions and complete tests. 95% of participants met criteria for low error rates and high learnability, underscoring the user-friendly design of the CBB.
- Validity of the CBB in this unsupervised setting was confirmed through the observation of expected inverse relationships between test performance and increasing test difficulty and age.
In a paper published by Perin et al (2020) on the study, the authors note: “the data collected in this study do appear to retain similar psychometric characteristics as those collected from supervised testing of the same tests. As such, these results support the acceptability, usability, and validity of the CBB in the unsupervised assessment of cognition in individuals at risk of dementia.”
Cogstate’s suite of digital assessments are well suited for use in remote settings. Tests are designed for user-friendliness and efficiency, featuring automated scoring and intuitive rules with demonstrations and learning components to guide participants to successful test completion and reliable data collection.
The incorporation of remote, unsupervised cognitive assessments in clinical trials presents an exciting opportunity to continue to be explored within clinical research methodologies and highlights the potential of such approaches to make clinical research more accessible, efficient, and inclusive.