Advancing digital endpoints

As the industry moves forward with the adoption of digital health technologies, using more Real World Evidence and hybrid virtual / decentralised clinical trials, eCOA and digital endpoints will become a necessity for clinical trials. In particular, clinical trials in cardiovascular, diabetes, rare diseases and neurodegenerative ailments such as Parkinson's disease and alzheimer's will benefit from advances in, and adoption of, digital endpoints.

As the Internet of Medical Things (IoMT) becomes increasingly used in clinical trial protocols, early adopters willing to invest in these technologies may win market share, while those without sufficient investments may find themselves at a disadvantage.

In this whitepaper we discuss a framework for integrating digital health effectively and efficiently:

• Explore the significance of digital endpoints including digital biomarkers
• Build a case for the broader adoption of digital health technologies and digital endpoints
• Outline a strategy to best harness these innovations with an end-to-end framework to selecting and validating devices and endpoints
• Discuss overcoming internal barriers to broader adoption of mobile medical devices and wearables for remote health monitoring and virtual clinical trials
• Provide checklists for mHealth device selection and clinical data management strategy
• Consider the digital health technologies implications of the COVID-19 pandemic
• Demonstrate their future potential and impact on digital pharma R&D

The whitepaper will explore the challenges and weaknesses in using digital endpoints, and how digital endpoints can be successfully incorporated in a trial or observational study.