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THE PHARMA REVIEW (JULY – AUG 2018)

Six Common Quantitative Mistakes in Planning Clinical Trials

Douglas A. Milikien

Introduction: According to a 2014 analysis conducted for the Department of Health and Human Services, for any new drug compound, the total cost of conducting clinical trials across all phases can be as much as $115 million1. Failures are expensive. Even well planned studies “fail”, in that the outcome does not work out in the direction desired to support regulatory approval. However, a trial planning mistake that results in a significant design flaw compromises the ability to form rational scientific conclusions and is therefore the worst kind of failure. This white paper enumerates some common clinical trial planning mistakes that we have seen here at Accudata Solutions pertaining to data collection and quantification.

 

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