While pharma companies and specialist vendors used to be the drivers of technical innovation, it is now the consumer world which is providing the most exciting and potentially valuable advances in clinical development. Although today’s clinical trials industry faces long-standing efficiency challenges, there is now a fast-growing collection of consumer technologies that have the capability to address these obstacles, potentially determining the shape of clinical studies for many years ahead.
It’s important for sponsors to understand how such consumer technologies – such as activity trackers and other wearable devices – can be adapted for different purposes within the clinical trial environment.
Whereas consumer mobile health (mHealth) devices are relatively cheap and easy to use, they are currently limited to the generation of data for exploratory endpoints only and not designed to generate validated data. When validated data are needed, sponsors are still required to use specialist clinical trial devices such as ActiGraphs which meet the demands of regulators.
When sponsors use the correct technologies in the correct context, the continuous data they collect will undoubtedly lead to greater insight into patient experience and therapeutic benefits, which offers many advantages in clinical development.
It’s clear that, for the full potential of digital health technologies to be realized, the support of regulators is paramount. With drug developers being traditionally risk-averse, the onus is therefore on regulators to provide guidance on the regulatory-compliant nature of integrating such innovations into clinical trials. These current unknowns can be confusing for trial sponsors as, for example, while the FDA has decided against regulating “low-risk general wellness products,” it is interested in mHealth devices used to gather data against the primary endpoint of a trial.
Regulators must provide clarity on when and how new products can meet the requirements of clinical studies, thus providing sponsors with the confidence they need to begin wide-scale adoption. Ideally, this will occur soon, as the FDA is generally open to working with innovative digital health companies in the consumer space, as evidenced by its recent formation of a precertification pilot program under its Digital Health Innovation Action Plan.1
Coupled with the ePRO Consortium’s recent findings that support the appropriate use of wearables in study protocols2 – which aligns with the agency’s development of new mHealth Guidelines in response to the 21st Century Cures Act – this may be enough to nudge the agency into the development of more clear regulatory guidance.
In the long run, it will be up to pharma to define their needs in order to extract value from consumer technologies in their clinical research strategies. By working with wearable device manufacturers, other industry providers and consortia, trial sponsors can generate the evidence that regulators need to support adoption of these innovative technologies while working to demonstrate to the industry that the tools are a low-risk way to improve clinical research.
A final challenge facing the industry has been brought about by the introduction of wearable technology itself. Wearables, for example, are already allowing sponsors of clinical trials to capture unprecedented amounts of data. While this should be a boom for pharma, it is, in actual fact, also creating a fresh set of challenges in terms of how to take advantage of the huge potential insights they may hold. Nevertheless, systems now exist which can process and analyze the information in a way that yields meaningful insights and easy-to-understand reporting.
Implementing changes can be difficult for the typically risk-averse pharma industry, but equally, inaction carries its own dangers. Companies that take the initiative to leverage new wearable technology in their clinical research will undoubtedly benefit from trials that generate broader, more continual and insightful data sets while, at the same time, seeing the burden that trial participation places on patients and investigators significantly reduced.
For more information on how pharmaceutical researchers can leverage innovative wearable technology for positive results in the development and accessibility of new treatments, read “The Impact of mHealth on Real-World Data Collection.”
2. Byrom, et al, “Selection of and Evidentiary Considerations for Wearable Devices and Their Measurements for Use in Regulatory Decision Making: Recommendations from the ePRO Consortium,” Value in Health, 2017,