New clinical trial rules

Hey folks, below is a link to an article I think would be important to PSCers since it has to do with disclosing the results of clinical trials, including the timeliness of reporting. I have been waiting for the results of the Phase III trial of oral Vancomycin before trying it…and waiting…and waiting…and now I don’t want to wait any longer. I plan start Vanco this fall. Hopefully the new rules will require trial results to be posted in a more timely fashion.

I’m not sure if this makes much sense. It basically makes clinical trials even more of a hassle to deal with and it will discourage some thinly-funded trials (such as Stanford Vanco trials).

Stanford vanco trial has been extended from its original plan. It is difficult to find enough trial participants (especially without the budget and reach that Big Pharma has for its trials), and there isn’t much funding available to prioritize the analyzing of the various results. I think it is great that there is some research activity going-on (even if it is not fully FDA new drug approval process compliant as it needs easily >$100 million) .

Besides, the “results” are not clear what they mean. If patient delays showing up (or does not show up) in some follow-up test, there isn’t much that can be done. Some research analysis on the results (e.g. DNA analysis) may take years to find some surprise effect that explains the things. Some basic variables (lab tests, transplant done or not) are relatively easy, of course.

So I think the new rule is counter-productive and very harmful.
I doubt the Stanford vanco trials would have been done with these rules in place.

This is a bit like forcing $20 minimum wage (and later, be shocked that all those nice bookstores and coffee shops near you get closed).