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.
Stepping into leadership can be daunting. Whether it is becoming a line manager, or leading a study for the first time, as careers progress, priorities shift and more emphasis is placed on interpersonal and organizational skills. This can lead to self-doubt for first-time managers. A quarter of managers say they did not feel ready to lead others when they were first appointed.
The clinical trial industry has a problem--one that is exacerbated by flawed protocol designs, unrealistic inclusion/exclusion criteria, and other factors. Put simply, the industry must finally design trials around real-world patients and stop extrapolating narrow clinical trial data to wider patient populations.