Hi dignan,
This topic has come up before and I've never been able to find anything documenting the need for more than one phase III
http://www.fda.gov/cder/about/smallbiz/faq.htm Quote:
Phases of an Investigation
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.
If drug companies aren't required to hold more than one phase III, why would they voluntarily endure the time and, what to us laymen seems the huge cost of another phase III?
The clinical trial process has become more than just a requirement to prove safety and efficacy to the FDA. The drug companies have huge amounts invested to get their product to that point and the clinical trial process is also the only way they can prove to themselves whether or not the results justify the upcoming costs of production, advertising and distribution. What we see as the huge cost of another phase III is small change compared to accepting those costs without confidence that their new drug will pull a sizable market share from the current drugs. Maybe that's why the obvious phase III against one of the crabs has become so obvious?
I don't think you're going to see a second phase III in a hands down winner against the crabs.
Bob
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