Database, journal publications…why not both?

As we publish in a previous post, 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.

The problem is that this has been detrimental to the publication of these results in scientific journals according to a recent study that analyzes 600 trials picked at random from the database conducted by Agnes Dechartres, an epidemiologist at Paris Descartes University, and her colleagues.

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 and complete reporting of the efficacy of the drugs went from 79% in the trials database to 69% in the matching papers. This study shows that the information is more clearly and completely reported at ClinicalTrials.gov than in the published article.

It doesn’t seem to be very attractive to submit articles for publication where the drug works worse than placebo which create a bias in the scientific record.

Christopher Jones, a physician at Cooper Medical School of Rowan University in Camden, New Jersey, found no results published in journals for 29% of nearly 600 trials registered on ClinicalTrials.gov, something particularly striking. Another problem according to Jones is that phase I trials don’t have to be reported, nor do trials performed entirely outside the United States despite the existence of other registries, such as the World Health Organization’s International Clinical Trials Registry Platform.

Reference

Written by Dr. Belén Suárez Jiménez for The All Results Journals.