FDA clinical trial standards: Is there a serious problem with Phase III studies?

One of the first things I look at when I audit a clinical trial is whether or not the participants met the stringent inclusion/exclusion criteria required by the study’s protocol. An increasing number of Warning Letters that FDA writes to researchers is for violation of protocol requirements. Now, there is a well thought out explanation for why the stringent enrollment standards written in clear English by Dr. John M Grohol in the World of Psychiatry. I have put a link under Interesting Articles on the right (Phase III Trials).

Dr. Grohol maintains that trials are designed to exclude the majority of people who might use the drug after approval in part because the stringent criteria will make FDA approval easier by selecting participants where the drug will prove to be effective. I’m an inspector, not a research scientist so I can’t tell you if he is right. But he does have a pretty good argument worth reading. On the other hand, year after year FDA cites researchers for recruiting ineligible subjects. Why would drug companies write protocols their researchers can’t follow?

FDA has come in for some serious criticism because it insists on placebo controlled clinical trials as their “gold standard.” It seems to me that if we are going to have effective reform for health care, then we should take a long close look at how we design clinical trials and decide which drugs are approved for which indications. Just a suggestion.


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