Three Risks Sponsors Must Solve Before Adopting Digital Health Tools

The Three Risks Sponsors Must Solve Before Adopting Digital Health Tools 

As the cost of pharmaceutical research approaches $900 million per new drug, sponsors are looking for ways to make decentralized clinical trials more streamlined and cost-effective. Digital health technologies (DHTs) are proving to be one of the best ways that sponsors can do just that. For example, wearables and sensors provide continuous, high-quality data that can merge with postmarket analysis and reduce reliance on physical testing sites, while electronic forms, smart devices, and telemedicine platforms lower the participation burden for patients, easing trial recruitment and increasing adherence.

But DHTs still come with regulatory, operational, and financial considerations that sponsors should prepare for as they transition away from older models of research and development. New technologies open up questions about clinical validation and regulation readiness. Before investing in a new DHT, here are the risks that we recommend trial sponsors consider.

In this blog, we will cover:

• How to navigate the regulatory requirements around DHT validation
• What operational and logistical factors sponsors often overlook
• Why digital health tools can pay off long-term

Navigating Regulatory Risks

While they acknowledge the many benefits of DHTs, organizations like the FDA and EMA still have a high bar for the evidence required to prove a tool’s reliability. In a landscape where 90% of drugs fail clinical trials, sponsors need to know that the resources they invest in won’t hold up the regulatory process or their ability to conduct large-scale, international trials.

Before adopting a DHT, sponsors should request detailed validation, audit, and security documentation to better understand how their data will be collected and accessed and whether the tool provides adequate data provenance. They may also need to consider whether data from a DHT, such as the substantial volume of data generated by continuous wearable devices, will need interpreting as an intermediary step before integration with their electronic data capture (EDC) platform, possibly introducing additional layers of data translation that will need to be made transparent for regulatory approval.

Looking Beyond the Device

It's easy to evaluate a DHT based on the device or platform itself, but the operational demands that come with it deserve equal scrutiny. Wearable devices must be shipped to and from patients, supported across multiple time zones and languages, and returned and processed at the end of the monitoring period. Even a digital portal requires active oversight, compliant data storage, and user-facing resources.

Sponsors transitioning to decentralized trial models should also recognize that going digital doesn't eliminate the need for physical site management. Many sponsors find that reducing the number of sites, rather than eliminating them altogether, while still incorporating DHTs is key to maintaining operational flexibility. It's also worth watching for hidden costs, as third-party data and trial management service fees can give a study the appearance of being fully automated while still requiring human oversight. Working with partners who offer integrated services significantly reduces the risk of protocol misalignment and costly integration delays.

Ensuring Quality, Reusability, and Efficiency

DHTs are a long-term investment, and the financial cost can look different when viewed across the full lifecycle of a program rather than a single clinical trial. While upfront acquisition costs can be higher than traditional tools, reusability changes the equation considerably.

Consider a sponsor choosing between thousands of single-use wearable sensors for a Phase III patient pool versus a smaller fleet of reusable, rechargeable devices cycled across cohorts. Though the per-unit cost of the reusable device is higher, the total number of monitors required to reach the target sample size is far smaller. Over time, reusable devices can reduce the overall device cost by 30%.

Reusable DHT infrastructure also accelerates trial setup, making it possible for clinical trials to get off the ground faster. If sponsors already have the technology they need and the infrastructure to use it, moving right from data collection for regulatory approval to postmarket fine-tuning is easily achieved, extending that initial spend further to increase ROI.

Moving from Adoption to Advantage

DHTs have the potential to fundamentally improve how decentralized clinical trials are designed and executed. But realizing that potential requires selecting tools that are not only clinically validated, but operationally ready and financially sound. Digital health tools like Vivalink’s medical grade wearables are already supporting faster, smarter, and stronger trials, positioning sponsors for success.