Drugs and Devices
by Laura DeStefano | May 11, 2012 | Discussion Paper, Perspectives
Introduction Clinical trials in the United States have a rich history of involving academic, industry, and government institutions (e.g. the National Institutes of Health [NIH]) to address important medical questions. Nonetheless, over time, clinical trials in the...
by Laura DeStefano | May 4, 2012 | Discussion Paper, Perspectives
Introduction Clinical trials are a means of gathering information about medical products or services. In medicine, however, they are also the fundamental means for advancing the underlying science and have enabled the many advances we have made in health care over the...
by Laura DeStefano | May 4, 2012 | Commentary, Perspectives
One session of the November 2011 Institute of Medicine (IOM) workshop Envisioning a Transformed Clinical Trials Enterprise in the United States: Establishing an Agenda for 2020 focused on the need to develop new economic models for clinical trials and to change the...
by Laura DeStefano | Apr 27, 2012 | Discussion Paper, Perspectives
Introduction The gap between the growing demand for evidence to inform practice and our current state of knowledge calls for serious consideration about the best approach to developing a workforce capable of meeting those demands. As referenced in the discussion paper...
by Laura DeStefano | Apr 20, 2012 | Discussion Paper, Perspectives
Introduction Over the past decade, the symbiotic relationship between the clinical trials enterprise (CTE) and the health care delivery system has been subject to increasing amounts of stress. During this period, the CTE has primarily focused on process improvement,...
by Laura DeStefano | Jan 27, 2012 | Commentary, Perspectives
In 1965, when Medicare was enacted, spending for prescription drugs was less than $4 billion—so low that no one thought to include a drug benefit as part of Medicare. By 2003, the cost and importance of drug therapy was so high that Medicare Part D was enacted. Drug...
