Published in Vaccine Weekly, June 29th, 1998
As a result, argues U.S. National Institutes of Health researcher John Clemens, manufacturers with a successful vaccine often find themselves unable to market the product to developing countries and the vaccine-purchasing agencies that serve them.
He therefore recommends wider use of Phase IIIB "effectiveness" trials to demonstrate vaccine utility in realistic settings. Such trials would complement Phase IIIA efficacy trials, the gold standard of clinical research.
"[Determination of] efficacy maximizes the detectability of vaccine protection but...
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