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Actually the results were similar in the phase II trials with only 41 subjects being tested.
Last September we attended an interesting presentation by Dr. Mark Pegram of the Jonnson Comprehensive Cancer Center who is a leading investigator in many clinical trials. He explained the clinical trial process in great detail. There is more that meets the eye. The test criteria proposed by the manufacturer can number hundreds of pages. The FDA will study the proposal for several months, may require changes or additions before they give their approval to start the trial. Basicly the entire process is controlled by the FDA and there can be no deviation by the investigator.
Apparently the FDA considered 331 patients sufficient for this particular trial.
Regards
Joe
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