The FDA is making a considerable effort to drive efficiencies in clinical trial research, especially when it comes to oncology studies. In 2017 alone, there were 46 new oncology drugs approved by the FDA, including 18 Fast Track Designated products and 17 Break-Through therapies.
The reason? Regulatory agencies recognise the standard way of conducting studies through rigid phases and designs are limiting drugs from reaching patients fast enough to address the unmet need. They are becoming more flexible about accepting positive results, allowing trial sponsors to be more creative with oncology designs.
With the support of the FDA, sponsors can follow the science. You should be able to change your protocol based on what is working. Especially with expensive drug. And even more expensive comparators and combination therapies. When you have positive signals, you should be able to pivot direction to build a global programme and gather the required data to prove it.
The challenge is that most clinical systems are not flexible enough to adapt to mid-study changes without trial disruption. To address these challenges, it is crucial for sponsors to have a robust RTSM and specifically cohort management functionality in place.