by Laura DeStefano | May 18, 2012 | Commentary, Perspectives
The Institute of Medicine’s (IOM’s) release of the reports To Err is Human and Crossing the Quality Chasm in 1999 and 2001, respectively, were markers of a tipping point in U.S. health care. Prior to that time, “quality” in health care had largely been defined by...
by Laura DeStefano | May 18, 2012 | Discussion Paper, Perspectives
In Canada, as elsewhere, the translation of health research outcomes to development of products and services for health care and final implementation in patients does not progress as rapidly, efficiently, or successfully as it should. In order to address this problem,...
by Laura DeStefano | May 18, 2012 | Discussion Paper, Perspectives
Introduction Traditional randomised clinical trials are very expensive and time-consuming and often have poor external validity (Ware and Hamel, 2011). The challenge for modern medicine is to find ways of producing good-quality evidence with good external validity and...
by Laura DeStefano | May 18, 2012 | Discussion Paper, Perspectives
The arrangements for the regulation and governance of health research in the United Kingdom (UK) have evolved, piecemeal, over the past 30 years, and much is now enshrined in UK and European Union (EU) legislation. Each individual measure was introduced with the best...
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 11, 2012 | Discussion Paper, Perspectives
Statement of Purpose Rapid, seamless data exchange in cancer—throughout the continuum from research to clinical care—remains an unmet need with no clear path forward to a solution. We assert that there is a national urgency to find solutions to support and sustain 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
Once again, the challenge of how to constrain rising health care expenditures has caught the public interest, stimulated by concerns over rising federal debt and limited ability to generate tax revenues. I recently chronicled my unsuccessful efforts at stimulating...
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 | Commentary, Perspectives
Health care in America is in crisis. Population health and patient outcomes are deteriorating relative to the rest of the developed world, and much of the health care delivered today is not based on rigorous scientific evidence. This is attributable, in large part, to...
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