How a drug or vaccine gets approved: A description of clinical trials

[TZ]

There seems to be a lot of misunderstanding of the long and complex process that a drug or vaccine has to go through in order to be approved here in the US. Its much more involved than the company just presenting data or applying to the FDA for approval. Drugs and vaccines go through years long testing that while not perfect (see Vioxx) certainly are pretty strict.



These regulations have been in place as we know it currently since 1978 when Good Laboratory Practices, Good Clinical Practices, and Good Manufacturing Practices were established to insure that the testing practices were closely monitored and standardized to some extent.



Initially there is an R+D period called "Discovery" where the basic composition of the product is established. This can be as much as 3-4 years.



Next there is the initial or pre-clinical testing. This is where animal studies are done to establish two things:

A) The properties and reactions of the product, especially what the therapeutic value is.

B)Toxicological studies are done with the animals to see what side effects are possible, and what the safe dosages may be (note: with vaccines toxicity studies are also done with various adjuvant and vaccine combinations to see which works best..therefore anyone who claims that they can't find adjuvant safety study data is looking in the wrong place. Its such standard work that you don't find it in scientific journals but in clinical trial data available from the FDA under the freedom of information act)

This stage can be anywhere form 1-4 years.


Then comes Phase I studies. This is usually the shortest stage of the study. It has a small amount of healthy volunteers to determine the most effective dose, and with drugs it also looks at how the drug is metabolized and excreted. It also looks for acute or harmful side effects. If nothing harmful is seen, this particular phase can be as short as 6 months.



Next is Phase II. Now the clinical trial starts to get into the heavy duty part of the study. The target population for the drug or vaccine is used. The number of test subjects is much larger and the length of the study is much longer than Phase I. It also establishes dose ranges and provides both safety and efficacy studies.

http://misselisasworld.blogspot.com/2007/07/how-does-drug-or-vaccine-get-approved.html


This is a follow-up to an Vaccine FAQ I posted here a while back.FYI- for those of you who remember that essay in three parts I rewrote it and put it into a downloadable format thats available from my science message board under FAQ's:http://eurekasci.16.forumer.com/index.php

[OPERATIONMINDCRIME]

1. There Are Quite Rigorous Standards To Be Met, And I Thank God For The Men And Women That Dedicate

their lives to doing the research that can help so many millions of people have better or longer lives. Though no system is perfect and though there is no expectation that every medicine would be perfect, as a society we owe a heck of a lot to these researchers, scientists and patients that put the hard work into these studies.

[TZ]

2. yep

And thats why I posted this. I get tired of hearing all of these hard working and dedicated people/scientists bashed as "money grubbing shills with no interest in safety" because some of the corporate overlords in this industry behave badly indeed.