|

FDA Sets High Bar for Real-World Evidence in Rare Diseases

ByJeff Riegel

Real-world data (RWD) can be used to create historical control groups for clinical trials in rare diseases where a randomized controlled trial (RCT) is not feasible. But what happens when the US Food and Drug Administration (FDA) doesn’t accept it? Since passage of the 21st Century Cures Act in 2016, FDA has promoted the use…

Do Decentralized Clinical Trials Hold the Keys to Future Patient Focused Drug Development?

ByJeff Mocny

There’s a lot of buzz around the concept of decentralized clinical trials, and rightly so, given the lessons learned from our experience with clinical trials during the COVID-19 pandemic.  Decentralized trials are executed through telemedicine and mobile or local healthcare providers.  They rely on technology (or medical devices) and information sharing to execute a study…