Alzheimer’s clinical development has moved from decades of disappointment toward cautious optimism. For nearly 20 years, most Phase III programs targeting amyloid ended in futility, leaving clinicians and caregivers disheartened.
Because nothing stands still for very long in the clinical research enterprise and time is a precious commodity, rather than coming in the form of full-fledged, long-term programs focused on their needs, ongoing education for principal investigators (PIs) tasked with leading clinical trial teams often comes in other guises. These may include learning in an on-the-job manner, through structured (though perhaps scattered) courses, by attending sponsor/contract research organization–conducted trainings, or by completing online modules on specialized topics.
Those in clinical research who most strongly believe the old saying about how “the best offense is a good defense” may often be the same people who have good reason to understand that a regulatory inspection, sponsor audit, or period of institutional review board (IRB) scrutiny could descend upon their study site at any time, announced or unannounced, so the best tactic is ongoing vigilance.
Healthcare has always been slow to adapt to change. When other industries appear to be on time or at least close to catching up to the latest trend in the market, rest assured, healthcare is about a decade behind. However, one area where healthcare cannot afford to lag behind the times is the use of digital health—specifically, artificial intelligence (AI).
Unlike traditional clinical outcome assessments, which rely on intermittent and sometimes subjective clinic-based measurements, digital biomarkers enable a richer, more dynamic understanding of disease progression and treatment response. This article provides examples of how digital biomarkers are revolutionizing clinical trials, focusing on the authors' shared experiences managing trials within the fields of neurology and oncology.