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Mobile health, artificial intelligence, remote biosensors — these digital technologies once referred to the future of health care. Now, they are transforming the patient experience in early clinical trials.

Data collection gets a new look

Traditionally, clinicians have relied on patients to self-report their symptoms, as best as they can recall, to help evaluate treatment options. Increasingly, researchers and healthcare providers can use wearable devices to capture a steady stream of data from patients, providing a more thorough picture of overall health and how symptoms manifest within real-time disease progression. The data generated from these devices could help inform innovative treatment approaches tailored to patients’ needs across several disease areas.

Optimally, digital devices should be small, lightweight, comfortable, and easy to use. In an effort to minimize potential distractions that could modify participants’ behaviors and cause them to deviate from their daily routine, some devices are meant to be “ignorable,” without dials, numbers, or lights.

Wearable technology at work

In Pfizer’s Early Clinical Development (ECD) group — more specifically in the Pfizer Innovation Research (PfiRe) Lab in Cambridge, MA — scientists are conducting studies to gather data from wearables and gain insight into how best to utilize these devices in clinical trials more broadly. One such trial aims to measure behaviors, such as scratching, in people with atopic dermatitis, a skin condition that causes itchy flare-ups. Tim McCarthy, head of the Digital Medicine & Translational Imaging (DMTI) team within ECD, explains: “Think of someone who is scratching 100 times an hour. Maybe, with treatment, they only scratch ten times an hour. Currently, we have to rely on patient questionnaires to collect this information, but wearable devices would enable accurate tracking and quantification of scratch data in a patient-centric manner.”

Outside the PfIRe Lab, Debbie Pittman, a hematology lead research fellow in Pfizer’s Rare Disease research unit, is using devices — including an activity watch and an electronic diary — to help understand the unmet needs of patients with sickle cell disease. Pittman notes the goal of this natural history study is to truly understand what a patient’s life is like with sickle cell in real-time, adding, “We are exploring the use of digital tech to better understand the experience of a sickling crisis and help us identify the clinical endpoints that will be most meaningful for patients.”

Beyond the use of wearables in clinical development, Pfizer and Bristol-Myers Squibb recently announced a project with Fitbit, using an on-wrist wearable, paired with a mobile app, to help drive the timely diagnosis of atrial fibrillation (AFib) with the aim of improving earlier detection in individuals at increased risk of stroke. Following regulatory clearance of the AFib detection software on Fitbit devices, the companies intend to use the technology, along with educational content and guidance, to help encourage and inform users’ discussions with their physicians.

Improving the standard of care

Data collected through wearable devices could ultimately help determine if the endpoints measured in clinical trials are meaningful outcomes for a specific patient population. By digitally recording and analyzing their ongoing experiences with a disease, patients have a powerful new way to tell scientists and researchers what health outcomes might make a difference in their daily lives, and those insights, in turn, could potentially lead to the development of therapies that may improve those outcomes and experiences.

Wearables and apps, including the digital tools that Pfizer is testing, are making medicine “more precise and patient-focused,” observes Sandeep Menon, Senior Vice President and head of Early Clinical Development. “With technologies like these,” he says, “we are not only making advances in scientific progress and innovation, we are creating novel opportunities within the rapidly changing clinical trial landscape to capture the complete patient experience.”

“Digital technology is helping transform real-time data into insights that could help improve the standard of care and pave the way for the next generation of treatments,” Menon explains.

Although it will require focus and dedication for these novel technologies to have measurable impacts for patients, it’s clear these digital assessment tools will play an ever-growing role in both R&D and patient care.

To learn more about Pfizer’s work with wearable technology — and other scientific innovations — visit www.getscience.com.

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