Nice post, and thanks for sharing.I appears to me that the FDA...

Nice post, and thanks for sharing.
I appears to me that the FDA publication "Multiple Endpoints inClinical Trials - Guidance for Industry" does the following:

1. places a lot of significance on primary endpoints typically being the only ones allowed to be assessed statistically, and
2. secondary endpoints being not typically meaningful, unless the primary endpoint succeeded.

It's great to have some guidance on what is typically permitted and what isn't, and of course there will always be issues coming out of left field that will test the FDA's use of these guidelines.

Please correct me if I'm wrong, but isn't the process of selecting primary and secondary endpoints just basically an 'administration' requirement in setting up the trial? They each have their own target and statistical analysis required upon which to make a judgement on success. At present we have three fantastic results for secondary endpoints that are statistically significant. We also have a failed primary endpoint. How then can the FDA justifiably wave the guidelines at us and tell us that the secondary endpoints are somehow not statistically valid, meaningful or useable, due to the primary endpoint failing? I'm of the firm belief that they cannot ignore this.

I'm also of the belief that another trial shouldn't be required prior to approval because all the data is there already. The FDA can't honestly tell us we need another 5 year trial because the reduction in stroke, heart attack and cardiac mortality were designated as secondary endpoints (and not primary) 5 years ago, and therefore it all has to be done again? This would signal to me that bureaucratic BS will have taken over common sense, and that FDA's role in saving lives would need to be questioned. They're still trial endpoints, and they're still valid and meaningful.

Good luck to all.