While the clinical trial industry had been delving into wearable sensors, handheld devices and other decentralized trial solutions in recent years, the COVID-19 pandemic has accelerated interest in such devices. Such products enable researchers to remotely test and monitor patients, in order to increase patient safety and convenience, and to keep trials going during the global health crisis.
Outsourcing-Pharma (OSP) spoke with Jim Mahon (JM), vice president/chief strategy and marketing officer for ERT, about the benefit wearables and other decentralized technology, and how the partnership between ERT and APDM may benefit users.
OSP: Could you please give an overview of how attitudes toward and use of wearables has evolved in recent years?
JM: It’s no surprise that the industry’s interest in wearables in clinical research continues to grow. As more and more sensors are built into wearable and handheld devices, their usefulness in clinical trials increases, as they can provide more objective data types and improve the clinical trial experience for patients.
The examples are endless; to name a few, a patient holding a handheld device with advanced sensors can provide critical cardiac safety data from home, and precision-motion wearables can objectively measure total body movement according to patients’ individual lifestyles, giving sponsors greater insight into the true effect of their treatments in the real world.
This breadth allows for real-world evidence across all clinical trial phases. However, a key part of using wearables is understanding the context of the data. When sponsors use the correct technologies in the correct context (i.e., integrated with electronically collected patient reported outcomes data), the continuous data they collect will undoubtedly lead to greater insight into patient experience and therapeutic benefits, which will drive further adoption by researchers and offer many advantages in clinical development.
OSP: How has the pandemic impacted the use of wearables?
JM: The evolution from traditional to virtual, or decentralized clinical trials, which to a large degree includes the use of wearables, was already in process for some contract research and sponsor organizations prior to the onset of COVID-19. While new technology is typically adopted by the life sciences industry at a relatively slow pace due to regulatory and other industry-specific challenges, we’re seeing that the cadence has been accelerated in order to continue, and even improve, clinical trial operations both during and after the pandemic.
In an industry survey conducted by ERT in April/May 2020, 82% of the respondents indicated that they are now implementing elements of virtual trials – including wearables - due to the pandemic. Notably, when asked how they are collecting patient data during virtual trials, 49% of survey respondents indicated they are capturing data directly from sensors/wearables, like activity trackers, sleep monitors, etc.
OSP: Why is the partnership of ERT and APDM a great fit?
JM: APDM’s advanced technology, extensive research publications, and broad understanding of objective precision movement measurement complements ERT’s expertise in high-quality clinical trial data collection, delivering the most efficient and effective approach for trial sponsors developing new medical treatments for the millions of patients living with movement disorders today. The newly combined ERT will generate higher-fidelity and more powerful data, reinventing endpoint measurement in drug development for Central Nervous System (CNS) and other treatments.
OSP: How will this partnership/acquisition benefit sites/sponsors, and patients?
JM: By integrating APDM’s wearables and digital biomarkers with ERT’s eCOA, Cardiac, Respiratory, and Imaging endpoints, we’ll make clinical trials more objective, efficient, and cost-effective for clinical trial sponsors, ultimately benefiting all clinical trial stakeholders, especially patients. As an example, by integrating high-quality Patient Reported Outcomes (PRO) data captured by ERT’s industry-leading eCOA platform with data from APDM’s wearables and digital endpoints, trial sponsors will gain robust insights and more comprehensive safety and efficacy data to support faster development of new, more effective medical treatments for many therapies including movement-related disorders.
OSP: What else would you like to add?
In another recent ERT survey exploring patients’ response to digital health technologies, we found that 90% of patients who do not participate in research are willing to take part. Virtual trials can help us reach that significant mass - not just during the pandemic, but also after.
Patient-related challenges can be addressed through the implementation of virtual trials – whether conducted in full, where the study is completely virtual and there is no physical contact between patients and staff, or “hybrid,” where the study includes some virtual elements and some face-to-face interaction. Recruitment and enrollment can be managed digitally, not requiring an in-person interaction; compliance may be increased because of the reminders provided to study participants through apps, devices, etc., and retention may be higher because of the ease of an in-home, digital experience versus having to regularly travel to sites and manually document experiences.
With advanced technology, including wearables and other precision sensors, we can engage patients from a broader geographical span and make it easier for them to participate and manage trials with greater ease and accuracy, all of which improves clinical development and helps to bring more effective treatments to patients, sooner.
