As we move towards decentralized and hybrid trial designs, it is increasingly important to understand the feasibility and reliability of digital measurement tools.
Here, experts from Otsuka and Cambridge Cognition shared insights from a recent collaborative study, discussing the value of remote monitoring of health and behavior.
Dr. Corey Reuteman-Fowler, Director of Global Clinical Development in CNS and Digital Medicine at Otsuka, presented results from a 4-week non-interventional study in patients with Major Depressive Disorder (MDD), which aimed to evaluate health professional-assisted versus unassisted methods of decentralized trial design. We learned that assistance had no real impact on subjects and despite some participants’ preference for a particular method, data collection was not affected.
Methods of obtaining remote psychological and physiological assessments were explored, including the use of RMDAS, which allows clinicians to observe patients’ movements over video, to assess extra pyramidal symptoms. Challenges and benefits of recruitment via social media were discussed, particularly in relation to patient demographics.
Dr. Francesca Cormack, Director of Research and Innovation at Cambridge Cognition, demonstrated the use of voice-based assessments to capture extra-pyramidal symptoms. She spoke to the scientific rationale of using speech as a digital biomarker, including the overlap of brain regions affected by extra pyramidal symptoms and brain regions controlling speech movements.
Two tasks, namely sustained phonation and PaTaKa, were used to analyze vocal acoustics and characteristics of speech. A machine learning algorithm to classify patients experiencing extra pyramidal symptoms showed high accuracy for both global extra pyramidal symptoms and specific subdomains such as slowness or abnormal and involuntary movement.
Drs. Reuteman-Fowler and Cormack summarized take home messages from this study:
- Clinical efficacy measures can be collected remotely for clinical interpretation.
- Decentralized trials, with or without healthcare professional assistance, show promising operational feasibility.
A thoughtful Q&A session explored the broader implications of this study for psychiatry, the promise and challenges associated with regulating digital measurement, and the impact of decentralized trials on increasing diversity in clinical trial populations.