Sep. 12, 2010

Assay Sensitivity Can Be Higher in Single-Site Than Multiple-Site Acute Pain Studies: A Case Study


Clinical trials on new analgesics targeting the treatment of acute pain often fail to statistically differentiate active drug from placebo, despite, in many cases, known efficacy of the study product in question.

The reasons for trial failure are most likely multifactorial, including trial design, placebo response rates, and site-tosite variability.

Systematic reviews have shown that increasing numbers of sites increases the risk of study failure.

The purpose of this investigation was to perform a post hoc analysis on a large multicenter acute pain study in which 1 research group accumulated a substantial proportion of the overall study sample, providing an opportunity to compare the assay sensitivity of a study conducted within 1 research group with the assay sensitivity conducted under similar conditions at a large number of sites.

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