Eric J. Daza | Founder and Chief Editor, Stats-of-1

“The framework will benefit several industry groups that must coordinate with the FDA and other regulatory bodies to define, operationalize, collect, and analyze digitally recorded measures. These groups are frequently found in pharma, biotech, medical device, and digital health companies.

Groups focused on patient-centered outcomes and digital health will directly benefit, as will real-world evidence (RWE) teams. The framework’s structured workflow gives these groups a procedure for developing digital endpoints—one they can use to align with sponsors and regulators on what needs to be done and how to do it. Other teams will use these validated digital endpoints to design studies for medical affairs research, market access research, and randomized controlled trials.”