ARTICLE | Product Development

Digital endpoints could be the key to patient-focused drug development

Digital endpoints offer unambiguous promise, but who will take on the risks and challenges of developing them?

October 31, 2023 10:28 PM UTC

The long-term goal to bring the patient voice into clinical development may have a new lease on life with the toolbox of digital endpoints now emerging. The challenge for companies is to find efficient paths to validation. 

There’s not much dispute about the potential benefits to both patients and drug developers for using digital endpoints in principle, and on the whole, there’s regulatory buy-in for the concept. But as with all disruption, changing established practice is hard, and with the rigid system of clinical trials and the regulatory paradigm that dominates today, it becomes a question of risk-taking, and of who will lead the way. ...