Digital Endpoint Strategy and Validation

Life Sciences, Clinical Trials, Commercialization & HEOR,
  • Friday, May 22, 2020 | 11am EDT (NA) / 4pm BST (UK) / 5pm CEST (EU-Central)
  • 60 min

The COVID-19 pandemic has heightened interest in mHealth and mobile technology to capture patient insights outside of the traditional clinical setting. Although mHealth devices and sensors are continuing to evolve, and it is now possible to capture a vast array of physiological data, the operationalization of digital trial is not without challenges.

Now more than ever there is a need to generate data from connected devices that are robust, reliable and relevant, of sufficient quality and ensuring minimal data loss. At the heart of the decision to use a digital device in a clinical programme is the study objective. However, as more of these technologies are being used in clinical studies, questions are arising as to how to ensure that the data generated by these devices can be validated and used to support endpoints.

In this presentation, it will be proposed how the application of COA principles and techniques can build the evidence package, when considering the evidence required to support digital endpoints for their submission to regulatory bodies and reimbursement stakeholders.


Marie McCarthy, Senior Director of Innovation, ICON

Marie McCarthy has over 20 years of experience working in the area of medical devices and in vitro diagnostics. Her focus for that last 11 years has been the use of wearables and sensors to generate digital endpoints in clinical trials. She has been with ICON for five years working as a Subject Matter Expert (SME) in the deployment and use of wearables and sensors in clinical trials. As part of the ICON innovation team, McCarthy provides insight into outcomes addressed by wearable technology and has designed and led a number of pilot projects focusing on the use of mHealth technologies in redesigning the clinical trial. She has presented at a number of Industry and Scientific Conferences, is a member of a number of industry panels including DIA wearables workstream and DIME, co-leads one of the MobliseD work packages and has authored over 50 publications on the use and implementation of wearables in clinical trials. McCarthy has an MSc and an MBA.

Message Presenter

Rachel Ballinger, Principal, Patient Centred Outcomes, ICON

Rachel Ballinger has over 20 years of research experience, mainly using qualitative and survey methods. She is currently serving on the ISPOR Performance Outcome Assessment Taskforce. 

Since joining ICON in December 2011, Ballinger has been working as a Project Director and formerly as Project Manager to undertake various studies such as utility studies; assessment of health related impacts on carers and of non-consented medication changes; validation of performance based measures; and in-depth review of COA measures. She has also contributed to FDA dossier development, qualitative research of patient-relevant endpoints and supported numerous other studies via interviewing, literature reviewing and manuscript writing.

Prior to Oxford Outcomes, Ballinger worked for six years as a Research Fellow at the Cancer Research UK Sussex Psychosocial Oncology Group, University of Sussex. Ballinger has a PhD in Medical Sociology focusing on the interplay of different types of knowledge about childhood asthma.

Message Presenter

Hannah Lewis, Principal, Patient Centred Outcomes, ICON

Hannah Lewis is a skilled and strategic outcomes research consultant, with experience in Clinical Outcome Assessment (COA) development and validation, strategic consultancy projects, COA quantitative data analysis, patient surveys and preference studies.

Her research experience has spanned numerous therapeutic areas including appetite, obesity, nutrition, diabetes, endocrinology, infectious diseases, immunology, gastroenterology, oncology, respiratory, rare diseases, aesthetics, haematology and eating behaviour.

Lewis has vast experience in a wide range of statistical analyses including psychometric evaluation and estimation of clinically meaningful change for COA instruments. Prior to joining ICON, Lewis worked in public health research and completed a PhD at the University of Cambridge, Gonville and Caius College, funded by a UK Medical Research Council scholarship. Lewis also holds a BSc (Hons.) in Biology from the University of Bath, as well an MSc in Nutrition from King’s College London.

Message Presenter

Who Should Attend?

This program is intended for professionals from pharmaceutical, biotech and medical device companies involved in:

  • Clinical Operations
  • COA / eCOA
  • Real World Evidence


What You Will Learn

In this webinar, the speakers will:

  • Present a strategy to identify devices that are “fit for purpose”
  • Outline a framework for Digital Endpoint selection and validation to ensure the outcome measurement is robust, reliable and interpretable
  • Address the key considerations that arise when using digital technology to support endpoint generation in clinical studies such as Device Selection, Endpoint Reliability and Sensitivity, Meaningful Change Thresholds and Analysis Strategy and Interpretation

Xtalks Partner

ICON plc

ICON plc is a global provider of outsourced development and commercialization services to pharmaceutical, biotechnology, medical device and government and public health organisations. The company specializes in the strategic development, management and analysis of programs that support clinical development. With headquarters in Dublin, Ireland, ICON currently operates from 98 locations in 40 countries and has approximately 15,100 employees. Further information is available at

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