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Hi Christie and list;
There was a paper written by Victor Montori and others in 2005 and published in JAMA about this.
Here is a link to the University of Pittsburgh Journal Club (Critical Care Medicine) about the paper.
They found that a large percentage was later found to be either the opposite or no effect.
Best wishes,
Dan Mayer, MD
Professor Emeritus in Emergency Medicine
Albany Medical College
Five years ago or so we saw so many reports with early trial termination we defined critical appraisal criteria to determine when such a report could be considered high-quality (level 1) evidence. This is what we came up with:
1. In cases of early trial termination
· Stopping decision made by independent monitoring board without competing interests
· Interim analysis preplanned
· Statistical stopping rule accounts for multiple assessments (lower p value threshold) for early termination benefit
· Clinically significant differences with absolute benefit/harm warranting early termination
· For classification of level of evidence for a specific outcome (which may be different than outcome used for stopping decision), outcome has sufficient statistical results such that trial continuation would be unlikely to change these results
Brian S. Alper, MD, MSPH, FAAFP
Founder of DynaMed
Vice President of EBM Research and Development, Quality & Standards
dynamed.ebscohost.com
From: Evidence based health (EBH) [mailto:[log in to unmask]]
On Behalf Of write words
Sent: Tuesday, December 02, 2014 2:01 AM
To: [log in to unmask]
Subject: stopping a clinical trial early: is it unusual? when is it ethical?
I’m looking into writing something about clinical trials that were halted early (as several PrEP ones have been), and I’m wondering:
-How unusual is it for a clinical trial to be halted early?
-What are the ethics of doing so?
-Are there any formal (or informal) guidelines or rules on when this should or can be done?
I’m also, of course, looking for examples. I have a few, but would like to collect some more. It may be asking too much, but I’d love to find statistics on how often this has been done.
best,
Christie
Christie Aschwanden
Email: [log in to unmask]
Website: www.christieaschwanden.com
Blog: www.lastwordonnothing.com/category/christie/
Twitter: @cragcrest