Commentary in the NEJM on the recent CRDAC evaluation of rivaroxaban, based on the ROCKET-AF study, a noninferiority trial.
Review article in Nature about cancer cell metabolism as a target for drug development.
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.
FDA perspective on the risk of myopathy vs. benefit with high-dose simvastatin.
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: