A key question that must be answered in an OTC switch program is whether potential users of a new OTC product can appropriately self-diagnose the condition the drug treats, make a correct self-selection decision based on the label, and safely use the drug for its intended purpose. These are questions that can only be answered by an actual use trial. The design principles for the conduct of high-quality observational trials are quite different from the principles of experimental trial design. However, these two approaches to research do not conflict with each other-observational studies are the best vehicle for evaluating real-world safety, whereas experimental trials are necessary to assess efficacy.
We think that a study to evaluate safety in real use should recruit subjects in a place they really get their drugs. We therefore have developed a group of more than 150 retail pharmacies throughout the country. A subset of those pharmacies is selected to meet the needs of any given study. Other research principles we incorporate in the design of an actual use trial include minimizing obtrusiveness and reactivity (the tendency for the evaluation of behavior to affect that behavior); sizing the subject sample to best meet the needs of the development program; enrolling everyone who self-selects into the trial (whether or not they meet the labeled selection criteria); using targeted recruitment methods that as much like natural advertisements as possible (consistent with principles of ethical research), and use of real drug packaging and a tested label.
These principles may seem obvious in the abstract, but the real challenge of actual use research is the application of those principles to a real problem. We are happy to come visit you and discuss the science of actual use trials as you have the need.
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