Commentary in the NEJM on the recent CRDAC evaluation of rivaroxaban, based on the ROCKET-AF study, a noninferiority trial.
Editorial by Ralph D'Agostino on progression-free survival replacing overall survival as the primary endpoint for FDA approval, with the recent experience of Avastin as a treatment of metastatic breast cancer as an example. Commentary in the New England Journal of Medicine that outlines the new FDA safety reporting regulations for clinical trials, effective March 28, 2011. A New England Journal of Medicine commentary outlines ways to reduce the costs associated with the treatment of cancer. Among the suggestions: reduced surveillance testing and imaging, use of sequential monotherapy (instead of combination therapy), and reducing chemotherapy dosing in metastatic solid tumors. The AIM-HIGH study of Niaspan (extended-release niacin) was halted by a data safety monitoring board due to a lack of benefit. The study enrolled patients with a history of cardiovascular disease, high triglycerides, and low HDL. A summary can be found here. A study that suggests a solution to overcome the tendency for patients to stick with proven treatments rather than trying something new: pay clinical trial subjects more money for their participation. An article in the British Medical Journal on being an expert medical witness; written for the English legal system, but applies to the U.S. legal system as well. Also has links to expert witness organizations: http://careers.bmj.com/careers/advice/view-article.html?id=20003042&q=w_bmj | ArchivesOctober 2011 Categories |
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