This gets curioser and curioser. Below is a somewhat dated (1992) link, but look what it is saying. I read this to mean that when it comes to experimental drugs for gram negative sepsis, the FDA's private data bank entitles it to "preempt" standard models of which patients were included and which were excluded from the study arms. This would certainly explain Monday. But is there another interpretation?
chestnet.org
<<A patient who is to be treated with an innovative therapy should have a clinical presentation that matches the entrance criteria used in the clinical trial for that therapy. However, for some entrance criteria (ie, temperature, heart rate, and respiratory rate), rigid limits were set for the purpose of conducting a clinical trial. When objective data have allowed a definitive diagnosis of the target population for which the innovative therapy is intended, exceptions to the listed entrance criteria can be made.
<<For example, in considering a therapy that utilizes antibodies raised against endotoxin for a patient who has a positive blood culture for Gram-negative bacteria, tachypnea, tachycardia, and
hypotension, the failure to meet temperature criteria from a previous clinical trial should not be used as a reason to withhold treatment. Also, since the Food and Drug Administration has access to a larger data base on any given agent, FDA labeling indicators may be different from clinical trial entrance criteria, and may thus preempt them.>>
For those who missed it here is the first link that started this thread --
chestnet.org |
