Clinical strategies to optimise software as a medical device (SaMD) for treating mental health

The rise of mental health awareness, coupled with rapid technological advancements, is transforming mental health treatment. Mental health disorders affect millions, and with increasing diagnoses, the demand for new, accessible treatments is growing. 

SaMD presents an opportunity to bridge this gap, but it requires careful planning and collaboration between sponsors and clinical research organisations (CROs) to maximise its potential. We examine how SaMD, particularly through digital therapeutics, is providing new solutions for mental health management in this whitepaper.

As mental health diagnoses in the US increase, there is a pressing need for innovative tools that extend access to effective treatments. SaMD, especially through smartphone applications, is a game-changer in delivering mental health care, offering real-time data and improved treatment accessibility. However, clinical trials for these digital therapeutics pose unique challenges that must be carefully navigated to ensure ethical and patient safety standards are met. 

• Clinical investigations of SaMD: Explore how SaMD can diagnose, treat, and manage mental health disorders
• Ethical and consent challenges: Learn about the psychiatric scales and evaluations required to assess patient mental capacity and ensure informed consent in mental health trials
• Patient recruitment strategies: Understand how to optimise recruitment for SaMD trials, factoring in technological proficiency and patient needs
• SaMD design and implementation: Discover the essential components of SaMD design, including tech proficiency, data collection, and patient training
• Regulatory and compliance considerations: Review the regulatory landscape for SaMD digital therapeutics and the steps required for a compliant and successful clinical trial

This whitepaper serves as a comprehensive guide for navigating the complexities of clinical investigations involving SaMD in mental health, offering strategies to optimise clinical trials while adhering to ethical, regulatory, and technological standards.