BACKGROUND: Patient-facing digital technologies (also called "Patient Technology" [PT]) have the potential to serve a variety of functions in clinical trials, such as capturing clinical endpoints, engaging patients, and facilitating remote study conduct. However, these technologies are not yet accepted as mainstream research tools, and the opportunities, challenges, and facilitators associated with their implementation in clinical trials have not been fully characterized. METHODS: In order to understand the factors affecting PT adoption, the TransCelerate Patient Technology Initiative conducted a series of surveys, interviews, and focus groups with approximately 600 subject matter experts, including pharmaceutical company representatives, clinical trial investigators at a number of trial sites worldwide, and clinical trial participants. All interview and survey responses were blinded and aggregated by a third-party consultant and themes were extracted. RESULTS: There was general consensus around the potential value of patient-facing technology as a clinical research tool, though a variety of challenges faced by each stakeholder were discussed. Detailed accounts of opportunities (improved patient experience, compliance, and engagement; clinical trial efficiencies; improved data quality and insights) and barriers (organizational and corporate cultural challenges, business-related challenges, user willingness and burden, and regulatory challenges) are reported. CONCLUSIONS: While the barriers to PT adoption explored here were numerous, they were also generally consistent. A number of proposals for establishing more holistic, collaborative, and strategic approaches to PT implementation in clinical trials are discussed. Such approaches could facilitate more effective, widespread adoption of PT, and thereby a more patient-centric clinical trial paradigm.

Accenture Life Sciences Berwyn PA USA

Clinical Data Management Hoffmann La Roche Limited Mississauga ON Canada

Clinical Trial Operations Sanofi Bridgewater NJ USA

Digital Clinical R and D IT Bristol Myers Squibb New York NY USA

IT Clinical Trial Planning and Management Boehringer Ingelheim Ridgefield CT USA

MSD Global IT Innovation Center Merck Sharpe and Dohme Corp Prague Czech Republic

Site and Patient Solutions UCB Biosciences Inc Raleigh NC USA

Technology Platform Operations Shared Solutions Janssen Research and Development Malvern PA USA

Citace poskytuje Crossref.org

Human-Centered Design Strategies for Device Selection in mHealth Programs: Development of a Novel Framework and Case Study