From telemedicine to mobile health wearables, digital health is a rapidly growing field of technology in the healthcare sector. Within this field, digital therapeutics (DTx) has emerged as a new class of medicine to combat rising treatment costs associated with an increasing national and global prevalence of chronic disease. As of 2022, 63 DTx appeared in the openFDA device databases and the global market for these products is only expected to grow, with projections estimated a value of US$9 billion by 2025. DTx is a group of evidence-based therapeutic interventions delivered through software programs or devices, such as smart inhalers and continuous glucose monitors; however, they require rigorous clinical testing to ensure accurate management of medical conditions. For this reason, biotechnology sponsors are increasingly relying on contract research organizations (CROs) for their clinical trial expertise beyond drug discovery and drug development. Read on to learn how CROs are advancing digital health and why they are a necessary partner in DTx development.
Designing Clinical Trials for Digital Therapeutics
Clinical trials are often essential for demonstrating the safety and efficacy of digital health products, and CROs play a crucial role in ensuring that these trials are designed and executed effectively. Many modern clinical research companies, like Vial CRO, are specifically built around a mission of delivering digital solutions for biotech and DTx sponsors. Therefore, enlisting the help of a CRO’s experienced panel of digital health experts can help optimize any new study to meet regulatory requirements, while also addressing the unique challenges of developing DTx products. Considering that successful CROs typically have a global presence, sponsors can take advantage of their existing infrastructure to navigate the complex regulatory requirement variations around the world.
The current landscape of digital health products include everything from leveraging artificial intelligence to rebuild motor skills to video games for treating mental- or behavioral-health difficulties. However, because these are inherently meant for use outside of traditional healthcare settings, designing appropriate clinical trials can be challenging. The right digital therapeutics CRO can address obstacles associated with data collection and ensuring patient safety by incorporating remote monitoring and other data management platforms. CROs can also provide expertise in selecting appropriate endpoints for clinical trials. With DTx, the endpoints may not be traditional clinical outcomes but rather changes in patient behavior or engagement with the product. A CRO’s digital health experts can help ensure that the chosen endpoints are scientifically sound and relevant to the target population.
CROS: Ensuring Data Quality and Security
Another way CROs are advancing digital health is through their role in ensuring data quality and security in clinical trials. DTx products generate vast amounts of data, but before they can be adopted more widely, sponsors must consider cybersecurity measures and data rights to ensure the product is accurate, reliable, and secure. Like their role in maintaining data privacy within pharmaceutical trials, CROs can help ensure data quality by implementing rigorous data management processes and utilizing advanced analytics tools to analyze and interpret trial data. Additionally, DTx software and products often contain sensitive patient information, such as medical histories and personal identifiers, which must not be vulnerable to breaches to comply with privacy regulations. CROs can help ensure data security by offering their existing infrastructure of robust security protocols and secure data management systems.
Collaborating with Digital Health Startups
DTx is still a developing field of therapeutics, which opens opportunities for small companies around the world to introduce innovative ideas early into the market. However, most digital health startups will often lack the required resources and specialized industry knowledge to conduct medical technology clinical trials on their own. Partnering with a CRO’s supportive network can connect these startups with niche vendors, provide cost-effective project management, and offer an in-depth understanding of patient pain points in clinical research to optimize clinical trial plans. Digital health management has the potential to introduce new treatment models for chronic diseases, and digital health CROs like ObvioHealth, Vial, and Curavit Clinical Research already offer an extensive portfolio of DTx development partnerships to help advance this field. By collaborating with CROs, startups can rely on their experience to navigate the complex landscape of clinical research and bring their products to market more quickly and efficiently.
The CRO for Digital Therapeutics
Relying on a well-established CRO for digital therapeutics is proving to be instrumental for sponsors to advance the field of digital health through their unique expertise in clinical research. As these needs continue to evolve, we can expect CROs to play an increasingly significant role in driving technological innovation in the field of DTx and improving the global accessibility of digital health products.
Vial is a full-service health technology CRO that recognizes the crucial role of technology in addressing the rising cost and treatment burdens of chronic diseases worldwide. Trusted by leading sponsors, our specialized teams are paving the way for modernized clinical research by leveraging digital innovation to deliver shorter study timelines, quality, affordable services, and a clinical trial experience that puts you first. Contact a team member today to discover how we can help!
