Clinical development has historically been a laborious and expensive process, driven by lengthy patient recruitment timelines, increasingly complex study designs, and high procedural costs, across different therapeutic areas. Additionally, a complex and dynamic regulatory framework has made it difficult to introduce new technologies to facilitate the development process.
There has been significant buzz in the life sciences industry surrounding the use of wearable devices that can be utilized for remote patient monitoring in clinical trials, which have the potential to significantly impact overall trial costs and efficiencies. Most recently, wearables have returned to the spotlight due to fresh approaches that harness artificial intelligence/machine learning (AI/ML) to process and analyze larger data streams.
Although intriguing, several issues have hindered adoption of these new technologies, primarily involving patient compliance, cost, concerns around data quality and accuracy, and lack of awareness surrounding these technologies and their utility. Our analysis shows some significant pros and cons that must be considered.
Data Collection & Patient Monitoring
Wearables provide a great opportunity for investigators to monitor their patients outside of the clinic, after an investigational drug has been administered or a new device is implanted. Currently, patients can be equipped with trackers that will monitor heart rate, lung function, breathing patterns, blood pressure, and other basic measurements that may provide insights into how the patient is responding to the treatment. Data from these trackers can be transmitted, in real-time, back to the physician for monitoring purposes.
But just how useful is this information? In other words, does this data provide any meaningful insight into the safety and efficacy of the treatment, or is it merely “nice to know”? The short answer is: it depends. Passively tracking the heart rate of a patient undergoing drug treatment for a retinal disorder 24/7, for example, will most likely not provide any mission critical data. However, it would be highly valuable for a patient suffering from coronary artery disease who had just underwent stent implantation or for classes of drugs, such as non-insulin antidiabetics, that potentially effect cardiovascular function. Thus, it will be important for the industry overall not to fall into the trap of collecting data simply because we can, but rather making a targeted effort to only collect data which ultimately gives a more vivid picture of clinical outcomes and support the safety and efficacy profile of investigational treatments.
More intriguing than the currently popular fitness watches, at least in a medical context, will be wearables designed to collect very specific types of patient outcome data. For example, in April 2017, the FDA approved the disposable Cardea Solo ECG monitoring system (Cardiac Insight Inc.) which can be used to diagnose atrial fibrillation (AF) after cardiac ablation. The device is intentionally designed not to interfere with daily activity, which will help to improve patient compliance. Technologies such as Cardea Solo blur the line between traditional diagnostic tools, used exclusively by the physician, and wearables, used jointly by the physician and patient, and demonstrates that wearables have potential to collect meaningful, actionable data that will ultimately help to improve overall patient outcomes.
There remains an opportunity to develop and market these types of wearable technologies specifically for use in clinical trials to support the development of investigational treatments, in other words, as patient screening and monitoring tools rather than just as diagnostic tools. However, much work still needs to be done to solidify regulatory standards surrounding the use of wearables for clinical study.
Incorporating wearables for the sake of incorporating wearables into trial designs may make for advantageous public relations, but will not have a significant impact on long-term success of development programs and the subsequent ROI. Thus, sponsors and other key stakeholders must be strategic in deciding which types of studies and treatments will benefit most from incorporating these technologies.
As this technology continues to evolve, particularly in the development of non-invasive devices designed for specific diseases and study types, we will likely begin to see greater adoption in clinical trials over the coming years. In order to derive the most meaningful benefits, companies must be deliberate in defining the types of data that are most meaningful to capture via wearables. The end goal of supporting trials must be held at the forefront of these new technologies.