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PP05-42: Implementing Digital Technologies in Neurology and Respiratory Clinical Trials: Lessons Learned

Poster Presenter

Andrei Pikalov

Head of Global Medical Affairs
Sunovion Pharmaceuticals, Inc.
United States

Objectives

To share our experiences with digital health technologies (e.g. external, wearable, implantable, and ingestible devices/sensors, as well as health apps and software accessible via users’ personal electronic devices) in clinical trials to improve data collection, patient access, and experience.

Method

Several digital health technologies have been incorporated into our clinical development programs in epilepsy and chronic obstructive pulmonary disease (COPD). The associated successes and challenges of these technologies, as well as practical solutions based on our experience, are presented.

Results

Epilepsy seizure frequency was investigated as an exploratory end point via a wearable watch device paired with an electronic seizure diary (smartphone app) to continuously record seizures in a 31-week, multicenter, prospective, open-label, Phase 4 study (NCT03116828) of adjunctive therapy with eslicarbazepine acetate in patients with partial-onset seizures. This system, which may potentially reduce biases associated with traditional paper/electronic seizure-recording diaries, was used to assess multiple parameters including concordance between daily seizure frequency recorded by the patient and the device. Several technologies have been tested in the respiratory therapeutic field. A customizable, interactive app to assist patients in the management and routine monitoring of their COPD, with cloud access to health care providers, was shared with pulmonologists (N=72) to gain feedback on its utility. Most respondents (75%; n=33/44) said they would encourage patients to use the app based on its ease of use, convenient accessibility via smartphone, and accurate and personalized triage. In a separate pilot study, patients with COPD (N=12) were asked to wear a biometric textile (shirt) with embedded physiologic sensors that passively collected overnight activity, including cardiac, respiratory, and sleep data, to assess the patient experience as part of our feasibility assessment to better understand the suitability of this specific wearable for the patient population of interest. Despite technical challenges, data were successfully obtained. In another single-site Phase 4 study of patients (N=20) with COPD receiving nebulized glycopyrrolate inhalation solution, a remote patient monitoring system (patch with integrated biosensors and wireless transceiver) worn on the torso was paired to a smartphone app to continuously monitor patients’ vital signs for up to 22 days; feasibility was assessed as an exploratory end point.

Conclusion

Our experience suggests that one of the greatest potential benefits of digital health technologies is the opportunity to collect subjective and/or biologic data continuously or at regular intervals outside of in-office visits during a patient’s normal daily activities to provide additional efficacy and safety information versus data capture from traditional episodic, posttreatment timepoint-based in-office visits. Passive collection of data in the patient’s regular environment also eliminates any potential effects from the in-office setting. Reduced reliance on frequent in-office visits offers the potential to expand trial recruitment to patients from wider geographic, socioeconomic, and ethnic backgrounds because patients are not restricted by proximity to a site of care. However, some challenges exist with digital technologies including acceptance of new techniques by both patients and investigators, technical issues, and data storage and protection. Many of these challenges can be successfully addressed by providing adequate training to staff and patients, ensuring the availability of appropriate infrastructure support, and conducting pilot studies before scaling up to larger trials. Our collective clinical experience suggests that digital health technologies have the potential to enhance the amount of clinically meaningful objective data collected in clinical trials, expand patient access to trials, and, perhaps, ultimately improve clinical outcomes.