Always valuable to have an insider perspective here. Curious to know the author's thoughts on potential upside in terms of time and budget saved (assuming a best case scenario of widespread adoption through P3 trials).
I don't have a precise estimate, but there are a couple of ways to look at the upside: statically and dynamically.
The static upside: we shave a few weeks off between each development phase and a couple of months off the FDA review time (the kind of benefit we see in FDA's real-time oncology review program), since sponsors need to spend less time cleaning their data and prepping it for submission and can get FDA input sooner.
The dynamic upside: Real-time trials get sponsors their data more quickly, which makes it easier to run innovative trial designs (especially Bayesian and adaptive methods), seamless trials, and other approaches. That could shave years off drug development.
On top of that, the tech used here makes the trials simpler to run, which could open up the possibility of more trial sites, more patients, and faster recruitment. The impact is much harder to quantify but the difference over time could be dramatic; not only speeding up existing trials but enabling new trials that were once prohibitively expensive or logistically difficult to pull off.
Always valuable to have an insider perspective here. Curious to know the author's thoughts on potential upside in terms of time and budget saved (assuming a best case scenario of widespread adoption through P3 trials).
I don't have a precise estimate, but there are a couple of ways to look at the upside: statically and dynamically.
The static upside: we shave a few weeks off between each development phase and a couple of months off the FDA review time (the kind of benefit we see in FDA's real-time oncology review program), since sponsors need to spend less time cleaning their data and prepping it for submission and can get FDA input sooner.
The dynamic upside: Real-time trials get sponsors their data more quickly, which makes it easier to run innovative trial designs (especially Bayesian and adaptive methods), seamless trials, and other approaches. That could shave years off drug development.
On top of that, the tech used here makes the trials simpler to run, which could open up the possibility of more trial sites, more patients, and faster recruitment. The impact is much harder to quantify but the difference over time could be dramatic; not only speeding up existing trials but enabling new trials that were once prohibitively expensive or logistically difficult to pull off.