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Regulatory Considerations on Noninferiority Trials and Rivaroxaban

10/13/2011

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Commentary in the NEJM on the recent CRDAC evaluation of rivaroxaban, based on the ROCKET-AF study, a noninferiority trial.
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Targeting Cancer Metabolism

09/04/2011

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Review article in Nature about cancer cell metabolism as a target for drug development.
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Editorial on PFS vs. OS as the Primary Endpoint in Cancer Drug Development

07/19/2011

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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.
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Risk of Myopathy with High-Dose Simvastatin

06/17/2011

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FDA perspective on the risk of myopathy vs. benefit with high-dose simvastatin.
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Commentary on New FDA Regulations for Safety Reporting

06/09/2011

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Commentary in the New England Journal of Medicine that outlines the new FDA safety reporting regulations for clinical trials, effective March 28, 2011.
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Commentary on methods to reduce cancer care costs

05/30/2011

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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.
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AIM-HIGH study of Niaspan halted

05/26/2011

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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.
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Therapeutic success stifles medical progress

05/25/2011

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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.
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Advice on being an expert medical witness

05/23/2011

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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


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