>Ray, this is the first I have heard reference to "long-term efficacy" being the reason for lack of FDA approval. Is this information available because I don't recall Hyrum mentioning it, or it being in any annual report.<
You have not heard that before because it is wrong! Thanks for the correction, I really botched that topic. The Phase 3 trials add larger groups of patients, randomized comparison between the new and old therapies, and (possibly) feature double-blind application. There are many links that present the differences in the trials phases. Here is one:
From http://lungcancer.about.com/od/whatislungcancer/f/What-Are-The-Different-Phases-Of-Clinical-Trials.htm
<Phase 1 trials are the first tests done on humans for an experimental medication or treatment. They usually involve only a small number of people and are designed to see if a treatment is safe.
Phase 2 Clinical Trials – Does the Treatment Work?
After a drug or treatment is found to be relatively safe, it is tested in a phase 2 trial to see if it is effective. Since a larger number of individuals are enrolled in these studies, further information is obtained about safety as well.
Phase 3 Clinical Trials – Does the Treatment Work Better Than the Standard Treatment?
Once a medication or treatment is felt to be relatively safe and effective, it is studied in a phase 3 trial to see if it works better than, or has fewer side effects than, the standard treatments available. Phase 3 trials are usually conducted on hundreds to thousands of individuals, and are usually “double-blind” studies; meaning that neither the patient nor the investigator knows which treatment is being used. If the experimental treatment is found to be either superior or inferior to the standard treatment, these studies are usually stopped early to allow individuals to receive the best treatment possible. >
The many Phase 3 trials for the BSD-2000 are showing far more than just marginal improvements over the comparison treatments. The improvements I have seen are from very substantial to large. These results will actually affect the whole 2000 series, since the more advanced units would be quickly approved by way of similarity. I wish BSD M would summarize these results in a chart!
I wonder if this will not soon happen: “If the experimental treatment is found to be either superior or inferior to the standard treatment, these studies are usually stopped early to allow individuals to receive the best treatment possible.”
>Also is there any trial that has been completed that will follow up long-term efficacy?<
I don’t know, but I assume long-term follow-up observations are commonly done. |
