The rules of the trials seem pretty simple, yet there are a lot of things that can happen that make the interpretation of those rules a matter of life and death for people with ALS. They deal with the ticking clock and a future with no great choices. It's more than troubling when a good choice unanticipated when the rules were written is taken from them.
I now realize that I have a lot of questions about how a clinical trial's rules came to be. I'm sure there are a lot of people involved -- the pharmaceutical company, scientists, the clinical investigators, the FDA -- oh, and patients -- and I have a lot to learn about who does what.
- Who sits down and writes the rules for a clinical trial?
- How many people are involved?
- Who has input into the inclusion and exclusion criteria?
- Who approves the rules?
- Who pays for the rules of the clinical trial to be written?
- How long does it take to write the rules?
- At what point does the FDA see the rules?
- How are clinical trial sizes established?
- Can any of the rules be clarified once the trial starts?
- Who handles the interpretation of the rules when a question arises?
- Who has the final say on an interpretation?
One thing I have learned in the last few weeks is that those many people involved all have a lot to learn from one another.