During my regular scanning of the health care literature, I recently came across an advertisement for an “Executive Master of Science in Biomedical Informatics” on the Health Sciences Campus of Columbia University in New York City. did not think of myself as a potential student for such a program, but nevertheless I was curious about [...]
Susan McCurry, PhD, a Seattle psychologist in the Department of Psychosocial and Community Health at the University of Washington, has written a practical guide to “becoming a resilient caregiver” of a family member with dementia. In clear and straightforward language, she describes a philosophy of caregiving designed to promote harmony and to minimize conflict within [...]
It should come as no surprise that physicians who use intimidation to dissuade individuals who question the safety of their orders create serious problems in the health care community. Unfortunately, it happens more frequently than most people are willing to admit, in both subtle ways and in clearly abusive forms of communication. Here is just [...]
The Food and Drug Administration (FDA) is trying to improve the way it assesses drug safety and communicates postmarketing problems by reorganizing the Center for Drug Evaluation and Research (CDER), the largest of the FDA’s five centers. A major aspect of this effort was the creation of a new position, Associate CDER Director of Safety [...]
On July 10, 2006, Scott Gottlieb, MD, the FDA’s Deputy Commissioner for Medical and Scientific Affairs, described the agency’s commitment to promote the use of adaptive trials. The first step is the development of regulatory guidelines. These guidelines will grow out of the work of an agency initiative known as “Critical Path,” which began in [...]
The current leadership of the FDA believes that there may be a better way to study drugs, particularly newer products stemming from genomic research. Adaptive trials permit investigators to adjust the protocol as a study unfolds. To accomplish this, researchers discard several pillars of RCTs, for instance, by taking advanced “peeks” at the results, which [...]
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