Richard L. Kravitz, MD, MSPH and Jodi Halpern, MD, PhD
Patients have a responsibility to discerningly present the drug information they receive from direct-to-consumer advertising and to be active partners with their physician in making health care decisions.
Physicians are cautioned that the two obstacles to reforming post-marketing clinical trials are the FDA's reluctance to revisit past approvals and its inability to enforce pharmaceutical companies' commitment to conduct Phase IV trials.
A review of legal decisions that have interpreted a hospital emergency department's obligation under the Emergency Medical Treatment and Active Labor Act to stabilize a patient.
Some commentators say comparative trials of FDA-approved drugs are overburdened by current Common Rule regulations and that researchers should not be required to obtain explicit consent for participation in the most innocuous of these trials.
Michael Farias, MD, MS, MBA and Rahul H. Rathod, MD
A distinguishing feature of a SCAMP is its ability to capture knowledge-based diversions from a recommended pathway and to “learn” from such individualized patient management.