The FDA has created this adaptive trial out of necessity. In an effort to expedite, modernize, reduce cost, increase efficiency, etc. which leads to increased success. Drug development is hard and needs to be less rigid and more adaptive and flexible. The FDA wants this to succeed. To see the fruits of their vision.
The adaptive trial is not some crappy small trial that bears unreliable results. It is the exact opposite. It is sophisticated, difficult to execute and bears an incredible amount of data. The results here are more reflective of what may happen in a larger trial. The data here show and reveal more than a traditional phase 2 trial can with hundreds of patients. The adaptive trial is working here and is being meticulously executed.
We are proving this methodology and the FDA likes it. If successful, it will change the way trials are run. People don't understand it and only see a small sample size. It is an easy argument to make successfully. The "it's a small sample size" argument will always overshadow the great data. However, it is not true. That's the point of the adaptive trial. Efficiency. More with less. And better. Once people begin to understand the power of this design, it will become "who the hell needs a sample size that big?"
Because of this we will have a much smaller and shorter phase 3. With hundreds of patients instead of thousands. I can hear it now. "It's only a few hundred, it should be a few thousand". That's BS. We are changing the game. Revolutionizing the big, ancient, traditional, slow methods with newer, faster and more reliable. With new technology and analysis tools. And crushing the amyloid hypothesis once and for all.
It like having a bunch of grumpy old people sitting around complaining how things have change and how their ways were better. When there's a kid sitting in front of them with an iPad that can do everything they can do with a tap of a finger. Yet, those old bags are still doubting it and saying it's not as good. "It's just a kid. It's just one gadget, it can't be as good". Blah blah blah.
Evolution. It's happening. Finally to our outdated system and will only get better. We will pave the way and prove them all wrong.
