As wearables have increasingly become integrated into the medical landscape, digital endpoints have become an exciting new tool to support clinical trials. When implemented properly, digital endpoints have the potential to enhance any trial, whether observational or interventional, or early or late phase. Digital endpoints harness the data from sensors and other digital health technologies that are collected during an individual’s everyday life, allowing for the capture of existing measures in a new way.

A recent analysis found the use of connected digital products in clinical trials has grown since 2000, with a compound annual growth rate of about 34 percent. Most notably, in 2017 and 2018, alone, more than 1100 unique trials included the use of a connected digital product, a more than tenfold increase in their use when compared to the early 2000s (1), indicating the utility and benefits of using wearables and other digital technologies.

The data collected from these devices can be used as exploratory digital endpoints in early clinical studies, contributing to the evidence required to successfully develop them for use as primary or secondary endpoints in later trials. Below we discuss how digital endpoints can benefit any phase of clinical research.

Improved safety and efficacy for early phase clinical trials

Novel digital endpoints in phase II studies can prevent promising drugs from being terminated unnecessarily due to lack of evidence by measuring concepts that could not be previously assessed or were measured inadequately.

Through the use of wearables and remote patient monitoring, digital endpoints offer the ability to improve our understanding of the safety and efficacy profile of a drug, which may lead to greater success when going from phase II to phase III of a clinical trial (2). For example, a study released by Bellerophon Therapeutics described how a physical activity endpoint was evaluated in a phase II study and — following an agreement with the FDA — how that same endpoint will be used as a primary endpoint in the company’s upcoming pivotal phase III study (3).

Confident and efficient decision-making in late phase clinical trials

While traditional endpoints are still necessary for FDA submission and regulation, digital endpoints and biomarkers can provide sponsors with contextual information to arrive at go/no go decisions confidently and efficiently. Similar to early phase clinical trials, novel digital biomarkers can also be used in a phase III study to monitor outcomes, and could indicate a failure that might otherwise go undetected using traditional endpoints.

Additionally, using frequent and continuous monitoring can supplement or replace observational assessments, offering the possibility of more precise and accurate assessments (4). For example, a smart device could measure coughing, instead of relying on a patient to record episodes of coughing in a diary. In another instance, blood pressure, which is traditionally captured in a clinic, could be captured in a home environment using a connected digital blood pressure monitor.

This collection of real-world evidence to inform digital endpoints can be applied to post-market approvals, extensions of patents and trials for multipurpose drugs. In addition, the data collected can improve our understanding of how new therapies affect daily life activities, such as the ability to go grocery shopping or walk up and down stairs.

A study with digital endpoints is a patient-centric study

Over the past several years, the patient voice has been given greater weight, not only in the design of studies but also in terms of trial preferences, thereby increasing patient centricity. For patients, the use of digital health technologies can decrease the burden of trial participation by fostering remote monitoring and encouraging enrollment for potential participants who may have been unable to enroll previously due to socioeconomic factors or travel limitations.

This is reflected in a CTTI study where the majority of respondents (76 percent), with a median age of 61 years, reported they would prefer to participate in a decentralised study using mobile devices over a traditional one, citing greater convenience and fewer in-person visits (5). Further, respondents reported they were willing to use a variety of technologies — including mobile apps, wearable devices and ingestible sensors — provided they were comfortable, convenient and easy to use, demonstrating that using digital health technologies can increase patient engagement and retention.

More importantly, with the current pandemic, it may be necessary to use wearables and remote monitoring for those patients who are immuno-compromised. Using digital endpoints places the patient at the center of a clinical trial, as endpoints need to be clinically significant and meaningful to individuals.

Therefore, the integration of digital health technologies into trial design starts with choosing the necessary digital endpoints. Combining the experience of a dedicated digital health technology team and patient-centred scientists can help sponsors develop a framework to map the process from device selection to digital endpoint validation.

ICON has conducted almost 50 studies across all phases using digital health technologies. To learn more about our framework for successful implementation, along with the critical role of digital endpoints, read our white paper — Advancing digital endpoints: An end-to-end approach to managing wearable devices through clinical development.

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Marra, C., Chen, J.L., Coravos, A. et al. Quantifying the use of connected digital products in clinical research. npj Digit. Med. 3, 50 (2020).

CTTI Recommendations: Developing Novel Endpoints Generated by Mobile Technology for Use in Clinical Trials. (2017). Clinical Trials Transformation Initiative.

Bellerophon Announces Agreement with the FDA on its Planned Pivotal Phase 3 Study for the Treatment of Pulmonary Hypertension Associated with Pulmonary Fibrosis. (March 2020).

Coravos, A., Khozin, S. and Mandl, K.D. Developing and adopting safe and effective digital biomarkers to improve patient outcomes. npj Digit. Med. 2, 14 (2019).

Perry, B., Geoghegan, C., et al. (2019). Patient preferences for using mobile technologies in clinical trials. Contemporary Clinical Trials Communications. 15.

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