All clinical trials must be reported in detail and made publicly available, BMJ Volume 329, p.626
The results of all clinical trials for new drugs and procedures must be released publicly if people are to get the full facts about their medical treatment, says a letter in this week's BMJ.
Writing from Japan Professor Furukawa, a specialist in psychiatry, argues that if detailed results of trials are not published openly, the public and health professionals are forced to rely on the drug company involved to interpret the trial findings an interpretation which may not reflect the results fully, says the author.
Examining the trial results of a drug for treating depression in children, Professor Furukawa argues that the drug company has mislabled some of the results, and wrongly categorized others. A child with symptoms of hopelessness and suicidal thoughts, who "punched pictures, broke glass and sustained lacerations that required six sutures", was categorized as a case of aggression, says Professor Furukawa rather than the more serious diagnosis of emotional liability or suicidal tendencies. Without access to the data itself, a doctor or parent is not in a position to challenge the drug company's findings.
All clinical trials results not just those from drug companies should be publicly accessible and reported in detail, argues the author. If such a policy were adopted internationally, healthcare professionals and the public could at last make properly informed decisions.
Source: Eurekalert & othersLast reviewed: By John M. Grohol, Psy.D. on 21 Feb 2009
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