Digital endpoints in clinical trials: DHTs. Game changer or not?
Digital health technologies (DHTs) like mobile applications, wearable sensors,…
Superiority, non-inferiority and equivalence in clinical trials: it's complicated...
The standard two-arm, randomized clinical trials compare an intervention to…
Human organoid models and their role in medical research
Human organoids are in vitro 3D biological structures that recapitulate…
The patent landscape for a potential COVID-19 treatment
Introduction Since the outbreak of the COVID-19 pandemic began in 2020, it…
Is the FDA ready for artificial intelligence and machine learning?
Software as a Medical Device (SaMD) - FDA’s AI/ML Plan The greatest advantage…
