The current state of the clinical trials industry faces a challenge that was only hypothetical three or four years ago. Thanks to the advent of cloud-computing and advances in simulation technology, sponsors can now design hundreds of thousands of clinical trials in less than an hour. Yet how do we choose amongst all of these myriad options in a way that optimizes commercial prospects? Cytel’s Chief Scientific Officer sits down with us to discuss the Re-imagined Clinical Trial.
Here are some key take-aways. Listen to the podcast to hear the whole conversation.
On the Strategic Use of Statisticians
“Well the first step is that we absolutely have to Explore Thoroughly. We cannot simply start with 6 or 7 options that sound promising. Nor can we shy away from 100,000 options on the table. So when development teams meet, we need a statistician in the room designing in real time. Whenever possible, we also need to give statisticians the strategic layout of the land.”
On Deciding Together for Commercial Success
“Then there’s the fact that we’re all measuring success a little bit differently. For some it’s about finding a good design and getting started quickly; for others it’s about maximizing probability of success even if it means lots of patients, lots of resources. Organizations need a way to Decide Together, to aggregate judgments across these differing needs.”
On Finding New Ways to Communicate Tradeoffs
“Traditionally, you would design every trial separately, then do pairwise comparisons of each with really rigorous math. This made it difficult to say, “Well what if we push back the interim look three weeks? Will this affect probability of success to the point that we would choose this design over another? We need to be able to visualize all the trials at once, and communicate tradeoffs quickly.”
Listen to the podcast by clicking below.
To learn more about the Advanced Design Framework click here.