Applied Clinical Trials-08-01-2005

Applied Clinical Trials

Connecting Bench to Bedside

August 01, 2005

Special Section: The Critical Path Initiative-Part One

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The Food and Drug Administration's (FDA) Critical Path Initiative and subsequent guidance documents have sparked the revitalization of the life sciences industry.

Cardiac Safety Speaks to the Heart of the Critical Path Initiative

August 01, 2005

Special Section: The Critical Path Initiative-Part One

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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.

FDA: Taking the Initiative

August 01, 2005

Special Section: The Critical Path Initiative-Part One

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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.

Down the Critical Path: Who Should Lead?

August 01, 2005

Special Section: The Critical Path Initiative-Part One

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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.

A Call for More Open Collaboration

August 01, 2005

Special Section: The Critical Path Initiative-Part One

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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.

Critical Path—Build It Collaboratively or Collectively?

August 01, 2005

Special Section: The Critical Path Initiative-Part One

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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.

The Public: A Critical Initiative Partner

August 01, 2005

Special Section: The Critical Path Initiative-Part One

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The FDA's Critical Path Initiative acknowledges long-standing and widely accepted challenges facing the clinical research enterprise and identifies several opportunity areas that may help to address these challenges.