“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)
