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Clinical Research and the New Public Partnership – A View from the South

DEBRA R. LAPPIN

ABSTRACT.

The clinical research enterprise in the United States is in a state of considerable transition. Many, including the US National Institutes of Health through its Roadmap Initiative, have called for a reengineering of the enterprise in ways that will build transparency, public disclosure of trial results, and enhanced public trust. This presentation will set forth a premise for a new public partnership model that will define the clinical research enterprise, in terms of both the relationship between the participant and the investigator in each clinical trial, and the relationship between the public and the clinical research enterprise as a whole. Ten guiding principles to direct this new partnership relationship are suggested. (J Rheumatol 2005;32 Suppl 72:27-29)

Key Indexing Terms:

RANDOMIZED CLINICAL TRIAL
NATIONAL INSTITUTES OF HEALTH


From B&D Sagamore, Washington, DC, USA.

D.R. Lappin, JD, Senior Advisor.

Address reprint requests to D.R. Lappin, B&D Sagamore,

5235 East Princeton Ave., Englewood, CO 80113.

E-mail: dlappin@mindspring.com




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