Here’s the scoop as I understand it, in layman’s terms. I used to work at a company called Covance (though NOT in a scientific capacity). Covance conducts clinical trials, as well as other laboratory contract research on foods, drugs, and commercial commercial proucts in a number of areas.
First, the DRUG is not Phase I, the TRIAL is Phase I. ALL drugs are Phase I at some point. And as those above pointed out, it’s about establishing safe dosages.
The DANGEROUS element of this is born out by it’s more informal name, toxicity testing. The may be tested by having groups of volunteers receive different, but consistent, dosages; or by gradually increasing the dosage of volunteers until physiological monitoring reveals adverse, or bordering on adverse, physiological reactions. Unfortunately, sometimes these adverse reactions occur immediately, or very quickly, and people die. The pool for these trials is drawn primarily from two sources: healthy volunteers, usually being paid to participate, are the overwhelming bulk of participants for most drugs. For some drugs being tested with an eye toward eventual treatment of very serious or fatal diseases such as cancer, the pool is expanded to include the most seriously ill of the sufferers of that disease.
I hope you will NOT rely on my word alone for what I say next, because I am NOT medically trained. Please, if someone has some knowledge contrary to my opinion below, tell Knighted Vopal Sword that I am full of crap.
I’m sorry to say this is very bad news for your friend. IMO, this means his physician has given up all hope on conventional treatment, and is hoping that a brand new drug, tested on your friend to the limits of his ability to cope with very high doses, may result in what might be termed a “miracle” cure, or remission, or reduction of tumor size or growth rate. I strongly suggest another physician’s opinion before doing this. Phase I trials are inherently the most dangerous, because it is the time that the LEAST is known about the effects of the drug.
