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Better Reporting of Clinical Trial Results

What are the problems with the reporting of clinical trial results?

“Most current ongoing trials are not built on all existing knowledge because all knowledge is not made publicly available.”(7)  Half of the ongoing 60,000 clinical trials in the United States will never publish results in a scientific journal, whether because investigators do not finish their work, do not want publicity, or find negative results, says Kay Dickersin, PhD, the director-designate of the Johns Hopkins Department of Epidemiology’s Center for Clinical Trials.(1)  This lack of knowledge sharing impedes the further creation of knowledge necessary to guide research and make treatment decisions.(7)

Even when clinical trial information is shared, it may be 15 years, until a drug is on the market or a trial is published.(7)  “Such a delay means that several different research teams may be studying the same thing simultaneously in isolation,…wasting time and resources. Trial participants may be unnecessarily exposed to risk if the substance under study has harmful effects that have not (yet) been disclosed. Research on humans can only be justified if the knowledge arising from that research is made publicly available for the public good.”(5)

“(While) drug companies are making public more information about medical studies they are conducting, some still withhold key details,” according to an analysis of a federal registry (clinicaltrials.gov) reported in the New England Journal of Medicine on December 22, 2005.(11)  The selective reporting of trial results to hide information that reveals “danger, unacceptable risk, or lack of effectiveness” and to highlight information that makes a drug look good: erodes “public confidence in the drug approval and safety process; harms patients and the scientific community; and leads to expensive duplication of effort, lost opportunities for collaboration, and underreporting of negative results.”(1)  “Bias in the published literature distorts the evidence available for other researchers, systematic reviewers, and ultimately for clinical decision making by health professionals and patients.”(5)

Copyright© 2012 Pipeline Project

All rights reserved. Revised: 01/26/12.