Companies withhold clinical trial information

AORN Journal,  Feb, 2006  

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Some pharmaceutical companies are deliberately withholding key information about their clinical trials, according to a Jan 4, 2006, news release from Medical News Today. In 2004, editors of many leading medical journals declared that they would not publish the results of clinical trials that were not Listed on the federal web site http://www.clinical trials.gov. The federal web site, established in response to the US Food and Drug Administration's Modernization Act of 1997, provides the public with up-to-date information about federal and private-clinical research trials in progress.

Several pharmaceutical companies are concerned that registering their studies in a public forum might allow their competitors access to proprietary information. The registry does not require the disclosure of the main outcomes that are being measured in a study or the actual medication names, so it is possible for a pharmaceutical company to omit the outcomes of the trials and to register a medication only as an "investigational drug." Although patients in the trials are given complete information about the investigations, this trend is disturbing because some patients who volunteer for clinical trials do so with the belief that their experience will be part of the public record.

More Clinical Trial Information Available On Federal Web Site, But Sometimes Incomplete, Study Says (news release, East Sussex, UK: Medical News Today, Jan 4, 2006) http://www.medicalnewstoday.com/medicalnews.php?newsid=35671 (accessed 4 Jan 2006).

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