By Robert Fiddaman
Some of you may know that I’ve been closely following the Paxil Clinical Trial in Japan. The trial, now completed, was labelled, “Clinical Evaluation of Efficacy and Safety of Paxil Tablets in Children and Adolescents with Major Depressive Disorder: Placebo-Controlled, Double-Blind, Parallel Group Study.”
I wasn’t the only one voicing my concerns about this particular trial. Medwatcher Japan, an independent Japanese drug watchdog, were also concerned. Back in July 2009 they wrote to GlaxoSmithkline Japan.
(1) The justification for determining the conduct of this study to be necessary and valid (how and why the conduct of the trial was determined to be necessary and valid)
(2) In particular, if the premise of conducting the clinical study is that effects can be expected for Japanese children, what information was used as justification for making that determination
(3) The most recent version of the study protocol (including records of previous revisions)
(4) Subject recruitment status (the names of the sites participating in the study to date, the number of people recruited at each site, and the Patient Information Sheet used at each site)
(5) Information on adverse events reported to date (information on number of emergent cases and clinical course of individual cases, etc.)