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Understand the submission and review process for high-quality clinical trials in medical journals, including peer review, ethical considerations, and decision-making criteria. Learn how negative trials and informative studies contribute to scientific advancement.
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Submissions in 2007 (n=13,043) Perspectives
Initial Submission Editor-in-chief Associate/ Deputy Editor Peer Review Editorial Meeting Statistical Review Initial Decision
Initial Submission Editor-in-chief Associate/ Deputy Editor Peer Review Editorial Meeting Statistical Review Initial Decision
Initial Submission Editor-in-chief Associate/ Deputy Editor Peer Review Editorial Meeting Statistical Review Initial Decision
Editors ask Peer Reviewers if the work is…. • High Quality • Novel • Ethical
High Quality Clinical Trials • Journals want the published research to be right. Findings from well designed and executed studies are more likely to be valid • Strongest evidence for cause and effect = Double Blind Randomized Controlled Trial
High Quality Clinical Trials • Randomization • Appropriate control group • Research subjects and investigators blinded to treatment assignment
High Quality • All patients screened and randomized are accounted for • Few patients lost to follow-up
High Quality - Analyses • Primary and secondary outcomes pre-specified and clearly defined • Data analyzed according to pre-specified plan • Intention To Treat – data analyzed according to patients’ original treatment assignment • Secondary and post-hoc analyses distinguished from primary analyses
High Quality • Sample size large enough to provide sufficient power to answer research question
Negative Trials • We ARE interested in negative trials! • Negative trials are of interest when: • Negative findings have important implications for practice or direction of future research • Large enough to provide definitive answer to question framed
Uninformative Negative Study • RCT of 20 patients • Primary Outcome P value • Treatment A 30% 0.10 • Treatment B 50% • Too small: clinically important benefit not ruled out
Informative Negative Study N Engl J Med Volume 354;21:2213-2224 May 25, 2006
Study Overview • In this randomized, controlled trial, there was no significant difference in 60-day mortality whether monitoring was performed with a pulmonary-artery catheter or a central venous catheter
High Quality • Complete and accurate reporting of adverse events • Statements such as the drug was “generally well tolerated” are not informative (and often not accurate) • Acknowledge when larger and longer studies are required to fully assess safety
Novelty • Study breaks new ground, defines new treatments or resolves major controversies
Ethical Clinical Trials • Adequate informed consent obtained • Protocol approved by an IRB • Risks to research subjects minimized and reasonable
Editors use the Reviews • Once reviews are in the editor reads the paper and the reviews • The editor, not the reviewer, makes the decision about the paper • We value the reviewers’ comments, but they are only consultants to our thinking process
Associate Editor makes a decision • Full consideration? • Manuscript is presented to all the editors • Minimal consideration? • Manuscript is on the agenda but discussion is minimal
Initial Submission Editor-in-chief Associate/ Deputy Editor Peer Review Editorial Meeting Statistical Review Initial Decision
Initial Submission Editor-in-chief Associate/ Deputy Editor Peer Review Editorial Meeting About 20% of papers fail at this step Statistical Review Initial Decision
Needs additional Experiments-0.5% We’re very interested 0.5% We’re interested 5% Possible Decisions Reject After Peer Review 42% Initial Reject 52%
Three Major Reasons for Rejection • Quality – the science is flawed • Novelty – the science is good, but has previously been published or does not advance the field • Specialty – it’s good, but not of general interest and belongs in a specialty journal
Initial Submission Revision Submitted Associate Editor Peer Review Editorial Meeting Final Decision Editor-in-chief Associate/ Deputy Editor Peer Review Editorial Meeting Statistical Review Initial Decision
The Author The Journal (In House Editors) Revision Process
Articles Published 2007 Original Research n=219 5.1% Review Articles n=72 37.5% Images n=97 3.3% Letters n=985 22.3% Editorials n=130 92% Perspectives n=149 26.6% Other Articles n=95 18.2%
Data from the Science Citation Index Impact Factor Impact Factor: The number of citations of a journal’s articles from the previous two years divided by the number of articles published during those same two years. Impact Factor Source: Institute for Scientific Information, Journal Citation Reports, 2008 .
Data from the Science Citation Index Immediacy Index Immediacy Index: The number of citations of a journal’s articles from the current year divided by number of articles published during that same year. Immediacy Index Source: Institute for Scientific Information, Journal Citation Reports, 2008 .