Closing Thought

Aug 01, 2005
Applied Clinical Trials
By Applied Clinical Trials Editors
In March 2004, FDA issued a provocative white paper: Innovation and Stagnation—Challenge and Opportunity on the Critical Path to New Medical Products. The Critical Path was identified by FDA as those parts of the R&D continuum that constitute bottlenecks in the drug development process.
Aug 01, 2005
Applied Clinical Trials
By Applied Clinical Trials Editors
The Critical Path Initiative (CPI), as it has come to be called, provided the FDA's analysis of the current drug development pipeline problem, characterized by a recent slowdown—instead of the expected acceleration—in innovative medical therapies reaching patients.
Aug 01, 2005
Applied Clinical Trials
By Applied Clinical Trials Editors
Ambitious in scale and scope, the Critical Path Initiative provides a rational construct for framing the central paradox of today's new drug and new device development industry.
Aug 01, 2005
Applied Clinical Trials
By Applied Clinical Trials Editors
FDA's Critical Path Initiative is an excellent idea, but is the time right?
Aug 01, 2005
Applied Clinical Trials
By Applied Clinical Trials Editors
The Food and Drug Administration's (FDA) Critical Path Initiative and subsequent guidance documents have sparked the revitalization of the life sciences industry.
Jul 01, 2005
Applied Clinical Trials
By Applied Clinical Trials Editors
Following the model of the home health care industry might be the answer to high subject dropout rates in clinical trials.
Jun 01, 2005
Applied Clinical Trials
Clinical departments are very expensive to run and maintain.
Apr 01, 2005
Applied Clinical Trials
By Applied Clinical Trials Editors
With the advent of personalized medicine and purported "race-based therapies" such as BilDil in the news, it is time the pharmaceutical industry makes a more concerted effort to engage racial and ethnic minority groups and the rural poor in clinical research.
Mar 01, 2005
Applied Clinical Trials
By Applied Clinical Trials Editors
Informed consent takes place in the brain. While that seems obvious, the implications of that statement go much deeper. To a great extent, both bioethics and federal policy are based on 17th century assumptions by philosophers such as Descartes—who knew nothing of the structure and function of the brain.
Feb 01, 2005
Applied Clinical Trials
In the biomedical research industry, and at Pfizer in particular, we are committed to what we call "The Three As"—making medicines available, accessible, and affordable.
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