The Digital Endpoints Ecosystem and Protocols (DEEP) Initiative: A Collaborative, Multi-Stakeholder Approach to Defining and Developing Standards for Digital Endpoints
Author(s)
Discussion Leaders: Marc Walton, MD, PhD, Janssen Research and Development, Janssen, Ashton, MD, USA Kai Langel, BSc, Janssen Research and Development, Janssen, Titusvile, NJ, USA; Mark Larkin, PhD, Vitaccess Ltd, Oxford, UK; Sheela Upadhyaya, Dip, Independent HTA perspective, London, UK
PURPOSE: To introduce the Digital Endpoints Ecosystem and Protocols (DEEP) initiative, outline its purpose, and gain feedback from the ISPOR audience by pressure-testing key DEEP service specifications from different stakeholder perspectives.
DESCRIPTION: This workshop assumes some knowledge of digital endpoints and contexts of use. It is aimed at people with experience of, or interest in, the development of innovative endpoints for clinical trials. The workshop will present DEEP, a collaborative initiative to define protocols and processes for the development and implementation of digital endpoints in clinical and real-world studies and guide the setup of standardized services that will accelerate adoption and expand usage.
Digital technology, including smartphones, wearables and other mobile sensors, has the potential to deliver new insights and provide richer, more patient-relevant measures of the impact of disease and interventions. Digital endpoints are becoming more sophisticated and are on the cusp of wide use – for clinical development, and presenting evidence to regulators, payers, healthcare providers, and patients. Marc Walton will use use-cases, both actual and conceptual, to present how digital endpoints differ from non-digital, including contexts of use and richness of the acquired knowledge. He will also identify challenges that need to be overcome to achieve the potential for digital endpoints. [10 min] Kai Langel will then present DEEP. DEEP engages and connects expertise across industry, consulting, patient-centered measurement science, academia, digital health, product design, and regulatory agencies. [10 min] Mark Larkin will run the interactive workshop, eliciting feedback and input on DEEP from the audience. This will be based around the draft framework and strategic design of DEEP, using live polling and text-based responses to pressure-test key components of the draft frameworks from stakeholder perspectives. [20 min] Finally Sheela Upadhyaya will provide a HTA perspective and anchor a panel Q&A session and then address audience questions. [15 min]Conference/Value in Health Info
Code
W8
Topic
Medical Technologies