Digital Health Merges with Clinical Trial Patient Centricity

The patient experience is becoming mission critical in the clinical trials industry, as there is widespread evidence of patient-centric initiatives across the enterprise. At PanAgora’s Clinical Trials Patient Experience Summit, three main topics stood out; companies engrained patient centricity guiding principles in their operational models, the new concept of patient connectivity is emerging, and digital health is rapidly gaining ground in clinical trials.

Patient Centricity Becomes More Defined

Aarif Khakoo, Head of Translational Medicine at Amgen, indicated that patient centricity has changed over the past two years. Khakoo explained that in 2016, there was a disconnect with engaged patients, as patients demanded value and were involved in healthcare decisions, however, the industry did not consistently incorporate patients in product strategies. Today, patient centricity consists in putting the patient at the center to continuously improve their experience with medical products from clinical trial design through post-marketing commercialization. This means involving the patient from defining unmet needs and product target profiles, designing studies, understanding dosing experiences, incorporating appropriate PROs, technology assessments, and patient support and adherence.

Khakoo emphasized Amgen’s patient-centric guiding principles, which include (1) valuing patient perspectives and engagement (i.e., honoring patients for clinical trial participation, providing information to patients and their families, partnering with patients to define important endpoint measures, and soliciting feedback from patients to improve studies), (2) valuing the patient experience (i.e., understanding how patients experience studies, utilizing patient voice tools for every study, addressing patient preferences during drug development, and helping sites uncover and resolve issues that patients experience), and (3) valuing patient health (i.e., communicating clinical trial results to help patients make treatment decisions that best suit their needs. Khakoo elaborated by providing specific examples including engaging patients in multiple settings to gain more profound insights into inflammatory bowel disease and developing a patient advisory board to enhance outcomes selection during endpoint design.

The New Concept of Patient Connectivity

The new concept of patient connectivity is emerging across the industry to address the gap between clinical trials and patients seeking participation. Carolyn Brehm, Bristol-Meyers Squibb Study Connect Business Lead, discussed how BMS created an innovative digital patient engagement platform to help address this gap (namely, Study Connect). Study Connect is a comprehensive platform for patients, caregivers, and healthcare providers (HCPs) to find and connect with new studies, by facilitating trial awareness, engagement, and participation. Study Connect helps educate and prepare caregivers about the concept of clinical trials, connecting patients with sites, and engaging patients throughout the clinical trial journey via digital engagement tools (i.e., videos, social media communities, and stories). Study Connect has multiple features including a referral program, condition screener, study education, and a clinical trials call center. The technology platform allows patients to create an account, search for studies, save studies, answer pre-screener questionnaires, and be a part of a social media community (monitored by BMS). Study Connect addresses the central challenge involving patient search fatigue; if a patient does not qualify for a study, they are more likely to continue to search for studies using this digital engagement technology due to its ease of use, notifications capabilities and social connectivity aspects.

Improved Adherence Through Smart Trials

Lisa Shipley, VP of Digital and Analytics Technology atMerck, described how the use of digital packaging could improve adherence in smart trials. According to Shipley, smart trials are a patient-centric approach towards enriching clinical trial data, and that involves using digital tools, such as smart dosing (mobile technologies to accurately monitor dose time and date), smart sampling (digital/lab-based technologies that are used in outpatient settings to monitor PK and biomarkers), and smart analytics (using technology to collect, integrate, and visualize data in real time). Merck initiated two pilot studies with a similar design (i.e., traditional trial and smart trial) to evaluate the effectiveness of smart technologies, and data supported the use of smart technology in clinical trials. For example, patient surveys from smart trials suggest strong support of the technology, as PK samples for at-home finger pricks versus blood draws at sites yielded similar results and variabilities. However, there were some discrepancies with potentially missed doses, and dosing confirmation technology was needed. The pilot also found that patients preferred less invasive blood sampling solutions, such as TAP^TM (which has microneedles), instead of traditional and more painful methods (i.e., finger pricks in clinics).

Digital and Remote Trials

Yan Chow, Digital Health Medical Director at Amgen, discussed Amgen’s first entirely virtual trial on migraine. The purpose of this study was to evaluate the correlation between migraine and activity levels. Amgen used the Apple Watch to measure activity and the iPhone Migraine Tracker app (via Apple Research Kit) to collect daily patient-reported outcomes. Amgen leveraged social media to recruit and enroll 70 patients with the support of Amgen Tweets and the migraine blog on Facebook. Chow presented data for daily questionnaire completion rates, and the figures appear to show approximately 60% compliance.  Chow did not elaborate on the reason behind the non-compliance rates.

Editor’s Note: .  PanAgora’s 4^thannual Clinical Trials IoT & Digital Endpoints Forum will occur Nov 7-8 in Boston.

Moe Alsumidaie, MBA, MSF is Chief Data Scientist at Annex Clinical, and Editorial Advisory Board member for and regular contributor to Applied Clinical Trials.