The limited ability of the nation’s clinical trials system to support drug development and evaluation exists within a broader context of a need for a “learning health system,” where “knowledge generation is so embedded into the core of the practice of medicine that it is a natural outgrowth and product of the health care delivery process and leads to continual improvement in care.” An essential component of such a learning health system is a robust and well-working clinical trials enterprise to support drug development; inform quality improvement; and support surveillance, international, and comparative effectiveness research.

The IOM’s Forum on Drug Discovery, Development, and Translation has established an initiative to address challenges facing the U.S. clinical trials enterprise and to engage stakeholders in an open discussion of potentially transformative strategies to improve the efficiency and effectiveness of clinical trials.

Workshop Objectives:

•      Frame the problem and discuss a vision for a clinical trials enterprise that is efficient and effective and fully integrated into the health delivery system of 2020. Define how the envisioned clinical trials enterprise differs from the current system and suggest approaches to transform our current system into a learning system.

•      Consider the following core themes in framing an agenda to effect transformation of the U.S. clinical trials enterprise:

—  Providing a vision for a clinical trials enterprise in the health care system of 2020.

—  Developing a robust clinical trials workforce.

—  Aligning cultural and financial incentives.

—  Building an infrastructure to support a transformed clinical trials enterprise.

•      Workshop presentations and panel discussions will be supported

and supplemented by discussion papers prepared by participants

in Forum activities. Each of the four workshop sessions will be

prefaced by presentations from discussion paper authors.

NOVEMBER 7, 2011

8:30 a.m.           Breakfast available Breakfast available Breakfast available Breakfast available Breakfast available Breakfast available Breakfast available Breakfast available Breakfast available Breakfast available

9:00 a.m.           Welcome and Introductions

JEFFREY DRAZEN, Workshop Chair


New England Journal of Medicine

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