Comment by civilitty
3 years ago
> The actual moral of the story maybe is that we should let third partys submit applications?
The application isn't a single page form, it's hundreds to thousands of pages detailing everything about the clinical trials ranging from the success criteria for each phase, the doctors and hospitals involved in the trials, and even tiny details like how much blood is going to be drawn, when it will be drawn, and how it's going to be tested.
They're impossible to write without the participation of almost everyone involved in the process since a significant part of premarketing approval is quality control of the final drug manufacturing process.
Yes? I meant they should be allowed to run independent clinical trials and then submit for approval.
I also did point out that the integral nature of the manufacturing process is a obvious potential problem. It, however, does not seem like a insurmountable problem. The specifications on sourced components and the quality control processes applied to them is already integral to the drug manufacturing process. This would just move it one level further up where the final drug produced by some existing production process is a “component”. They also already approve drugs for different uses and evaluate existing drugs for new uses, so it does not seem that qualitatively different from some existing approval procedures. I am not sure of the exact details and am not proposing a specific solution, but it certainly does not seem to be a deal breaker.
Not at all in the field, but are there standardized clinical trial "frameworks" that can be used in order to simplify the process ?
Designing clinical trials from scratch is a very difficult and time consuming process so almost all of them are modeled after previous successful trials targeting the same class of medicine - as specific to the new drug as possible.
There's a lot of copy pasting followed by customization - often by "contract research organization" consultants who specialize in different types of clinical trials - but there are no "frameworks" as we would understand it in software engineering.