vaccine trials

[michele u]

I have been looking into a vaccine trial. I got the paper work and looked it over. I was surprised when i read the line "this will not help you but may help someone down the road". Do they say this on all clinical trials? I know these vaccines have been keeping alot of people ned. I don't know why they would put this in the paperwork? does anyone know?

[brian]

Dear Michele:

The paperwork for vaccine or any drug trial will make disclaimers about the efficacy of any drug being tried. The reason for this is that the directors of the trial do not want to mislead anyone as to the effectiveness of any drug. No drug that is in a trial i.e. that has not been proven effective and approved for use by the FDA can represented as effective.

That being said, the simple fact that a drug has reached a phase II or phase III status indicates that the FDA or NCI has some faith that will do as projected. Further, as in the case with the vaccines being studied at the University of Washington, there have been a number of patients in the study since 1996 and the directors of the study have survival statistics for that group. Unfortunately, those groups are so small that they are not statistically meaningful, but they do give some indication as to the efficacy of the drug being tried.