I’m not much for vanity decorations on cars. License Plates, Bumper Stickers, Decals, whatever, they usually just annoy me. I don’t really care to know about the political leanings, sports affiliations, or group memberships of my fellow drivers….save through good conversation. I do so love good conversation. So when I am subjected to reading about these things, billboard style, on the back of their cars as I drive to wherever, I’m more prone to be annoyed than amused.
All that being said, I have noticed a recent trend on these car adornments to embrace the rather geeky technical aspects of the Pharma industry. For example, the other day while driving with my wife, we spotted a car sporting Pennsylvania plates with the ID number “21CFR11″. Now for those of you out of the know, 21 CFR part 11 is the US regulation governing the use of electronic records and electronic signatures in FDA-regulated functions (like drug development or manufacture). I can’t think of a Geekier thing to put on one’s car…I mean, that probably tops “I love Linux” as a mantra.
Another plate I saw a while back, this time from New Jersey, read “PHASE4″. That plate was a co-worker’s at a previous employer. Again, for those out of the know, with Phase 4 referring to studies performed for a possible new indication (use) for an already approved drug. Again, pretty geeky.
Living in NJ as I do with its high concentration of Pharma companies, I suppose it was just a matter of time. Now, I am interested in both Phase 4 and especially 21 CFR part 11, but I think I’ll keep that off my car.
An IND may be submitted for one or more phases of an investigation. The clinical investigation of a previously untested drug is generally divided into three phases. Although in general the phases are conducted sequentially, they may overlap. The three phases of an investigation are as follows:
Phase 1 includes the initial introduction of an investigational new drug into humans. These studies are usually conducted in healthy volunteer subjects. These studies are designed to determine the metabolic and pharmacological actions of the drug in humans, the side effects associated with increasing doses, and, if possible, to gain early evidence on effectiveness. Phase 1 studies also evaluate drug metabolism, structure-activity relationships, and the mechanism of action in humans. The total number of subjects included in Phase 1 studies is generally in the range of twenty to eighty.
Phase 2 includes the early controlled clinical studies conducted to obtain some preliminary data on the effectiveness of the drug for a particular indication or indications in patients with the disease or condition. This phase of testing also helps determine the common short-term side effects and risks associated with the drug. Phase 2 studies usually involve several hundred people.
Phase 3 studies are intended to gather the additional information about effectiveness and safety that is needed to evaluate the overall benefit-risk relationship of the drug. Phase 3 studies also provide an adequate basis for extrapolating the results to the general population and transmitting that information in the physician labeling. Phase 3 studies usually include several hundred to several thousand people.