Applied Clinical Trials-08-01-2005

Registries could strengthen the postapproval safety net-critical in the current cautious environment.

Tools for Clinical Trials Professionals

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

The EMEA's guidance is a roadmap for understanding current and future guidelines.

It's hard to argue with the basic premise of the FDA's Critical Path Initiative-to help the flow of medical products through the development pipeline.

FDA's Critical Path Initiative is an excellent idea, but is the time right?

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.

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.

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.

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.

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.

This innovative method increases flexibility, saves money, and supports the Critical Path Initiative.

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.