Half of US clinical trials go unpublished : Nature News & Comment

abernard102@gmail.com 2013-12-05

Summary:

"The results of clinical trials are going unpublished as much as half the time, and those that are published omit some key details, a study has found1. Google supercomputers tackle giant drug-interaction data crunch Twenty tips to help you interpret scientific claims How oral sex can cause throat cancer by transmitting HPV US law requires the results of medical research for drugs approved by the US Food and Drug Administration to be submitted to a database called ClinicalTrials.gov. Results, including adverse effects, have been made public there since 2008. Researchers who do not post results within a year of trial completion risk losing grants and can be fined as much as US$10,000 per day. But the database was never meant to replace journal publications, which often contain longer descriptions of methods and results and are the basis for big reviews of research on a given drug. In an analysis of 600 trials picked at random from the database, Agnes Dechartres, an epidemiologist at Paris Descartes University, and her colleagues have now found that only 50% had made their way into print.  For those trials that were also published in journals, complete reporting of negative side effects of the drugs — rather than just mentioning common events, for example — occurred 73% of the time in the trials database but only 45% of the time in the publications. Serious adverse events were mentioned in 99% of trials on the database but in only 71% of corresponding articles. Complete reporting of the efficacy of the drugs went from 79% in the trials database to 69% in the matching papers. Overall, the research was 'more clearly and completely reported at ClinicalTrials.gov than in the published article,' says Dechartres. The team’s results are published today in PLoS Medicine1 ..."

Link:

http://www.nature.com/news/half-of-us-clinical-trials-go-unpublished-1.14286

From feeds:

Open Access Tracking Project (OATP) » abernard102@gmail.com

Tags:

oa.new oa.data oa.policies oa.comment oa.government oa.usa oa.biomedicine oa.studies oa.clinical_trials oa.fda oa..clinical_trials.gov oa.pharma

Date tagged:

12/05/2013, 11:05

Date published:

12/05/2013, 06:05