Authors
Melanie Sekeres, Jennifer L Gold, An-Wen Chan, Joel Lexchin, David Moher, Marleen LP Van Laethem, James Maskalyk, Lorraine Ferris, Nathan Taback, Paula A Rochon
Publication date
2008/2/20
Journal
PLoS One
Volume
3
Issue
2
Pages
e1610
Publisher
Public Library of Science
Description
Background
In September 2004, the International Committee of Medical Journal Editors (ICMJE) issued a Statement requiring that all clinical trials be registered at inception in a public register in order to be considered for publication. The World Health Organization (WHO) and ICMJE have identified 20 items that should be provided before a trial is considered registered, including contact information. Identifying those scientifically responsible for trial conduct increases accountability. The objective is to examine the proportion of registered clinical trials providing valid scientific leadership information.
Methodology/Principal Findings
We reviewed clinical trial entries listing Canadian investigators in the two largest international and public trial registers, the International Standard Randomized Controlled Trial Number (ISRCTN) register, and ClinicalTrials.gov. The main outcome measures were the proportion of clinical trials reporting valid contact information for the trials' Principal Investigator (PI)/Co-ordinating Investigator/Study Chair/Site PI, and trial e-mail contact address, stratified by funding source, recruiting status, and register. A total of 1388 entries (142 from ISRCTN and 1246 from ClinicalTrials.gov) comprised our sample. We found non-compliance with mandatory registration requirements regarding scientific leadership and trial contact information. Non-industry and partial industry funded trials were significantly more likely to identify the individual responsible for scientific leadership (OR = 259, 95% CI: 95–701) and to provide a contact e-mail address (OR = 9.6, 95% CI: 6.6–14) than were solely industry funded trials.
Conclusions/Significance …
Total citations
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