Vaccine
by ResearchGrandma » Sun Sep 30, 2012 10:31 am
Helpful information is available at the NIH clinical trials site. (http://www.nlm.nih.gov/services/ctphases.html")
Basically clinical trials are conducted in phases (1,2,3 & 4).
Phases 1 and 2 are mostly to evaluate safety, look for side effects and identify proper dosages.
Phase 3 is where the drug is tested in large groups to compare effectiveness, compare to commonly used treatments, and monitor side effects.
Phase 4 is after the drug has been released and follows the drug in various populations and to continue to monitor side effects.
My guess is that this new vaccine is still in phase 1 testing to see if it causes any problems in healthy people.
If anyone is considering participation in any clinical trial, you should read the research consent documents very carefully before signing and make sure you understand them fully. The research documents should indicate that they have been reviewed and approved by the institution's Institutional Review Board (IRB). No doctor should rush you into signing - that is definitely a sign of a badly run research program.
Vaccine
-
- Administrator
- Posts: 12688
- Joined: Sat Aug 06, 2005 8:00 pm
Re: Vaccine
ResearchGrandma is right.
About ten years ago, a well-known C. diff. researcher conducted a limited study with only several participants. One of the test patients developed side effects - think it was reactive arthritis. The patient was a poster on this site and tried to use the site to contact one of the other participants - who didn't have side effects. The poster was belligerent and threatened to sue the doctor. He terminated the study.
From what I've read a safe vaccine is still about five years away, but wouldn't it be wonderful if a safe one was finally available?
About ten years ago, a well-known C. diff. researcher conducted a limited study with only several participants. One of the test patients developed side effects - think it was reactive arthritis. The patient was a poster on this site and tried to use the site to contact one of the other participants - who didn't have side effects. The poster was belligerent and threatened to sue the doctor. He terminated the study.
From what I've read a safe vaccine is still about five years away, but wouldn't it be wonderful if a safe one was finally available?
Return to “CDI - C. diff. Info. All You Want to Know and More”
Who is online
Users browsing this forum: No registered users and 17 guests