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There are many acknowledged benefits for the reuse of clinical trial data; from independent verification of published results to the evaluation of new hypotheses. However, the reuse of shared clinical trial data is not without obstacles. Here we present some of the issues and lessons learned from our own experiences in accessing and analyzing trial data; specifically, where we aim to combine and pool...
The Heart Protection Study 2–Treatment of HDL to Reduce the Incidence of Vascular Events (HPS2-THRIVE) showed that adding extended-release niacin-laropiprant (ERN-LRPT) to statin provided no incremental cardiovascular benefit vs placebo (PBO). ERN-LRPT was also associated with an excess of serious adverse experiences (AEs), some of which were unexpected (infections and bleeding). These findings led...
The validity of parent reports regarding children’s attention-deficit/hyperactivity disorder (ADHD) symptoms has been questioned. This study assessed whether parent reports were as sensitive as teacher reports to document change in ADHD symptoms during clinical trials with atomoxetine.Data were compared from two randomized, double-blind, placebo-controlled clinical trials of atomoxetine using different...
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