Closing Thought

Sep 01, 2005
Applied Clinical Trials
By Applied Clinical Trials Editors
Thoughtful application of eDiaries can make clinical development much more efficient.
Sep 01, 2005
Applied Clinical Trials
By Applied Clinical Trials Editors
Making important data more consistent and more accessible has the potential to improve safety and efficacy.
Aug 01, 2005
Applied Clinical Trials
By Applied Clinical Trials Editors
When the FDA stated that "the applied sciences needed for medical product development have not kept pace with the tremendous advances in the basic sciences" everyone seemed to agree.
Aug 01, 2005
Applied Clinical Trials
By Applied Clinical Trials Editors
Scientific discovery is, by its very nature, plagued by a lag between concept development and the acquisition of the tools necessary to fully explore a new technology's application.
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.
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