Global trials can unlock real advantages for sponsors, including access to diverse patients, faster enrollment, and more representative data across geographies. However, global expansion isn’t always the right move. For every sponsor that benefits, there’s one that overspends, underdelivers, or enters markets they were never built to support. In a high-risk industry that punishes missteps and rewards efficiency, the question any sponsor should ask isn’t how to go global. It’s whether they should at all.
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.