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2005 HSR&D National Meeting Abstract


1079 — A Leadership Role for VHA in Addressing the “Clinical Research Enterprise” Crisis

Author List:
Mittman BrianS

Objectives:
Several recent reports have described barriers and delays in the clinical research-development-implementation pipeline in the U.S. and abroad, characterizing the situation as a crisis. This presentation reviews major reports from the NIH, FDA and IoM and summarizes and critiques three components of their content: (a) their depiction of the crisis, (b) their analyses and diagnoses of the crisis's underlying causes, and (c) their recommendations. The presentation then proposes a leadership role for VHA and ORD in generating a deeper understanding of the origins of the crisis and in developing and implementing improved plans for accelerating the flow of healthcare-related innovations through the pipeline.

Methods:
A systematic summary and analysis of the reports' (a) depiction of the crisis, (b) analysis and diagnosis of underlying causes, and (c) key recommendations is coupled with insights and ideas from implementation theory and research and with ideas associated with VHA's "implementation initiative" (i.e., efforts to enhance the relevance and application of clinical research findings within VHA).

Results:
Implementation science offers numerous insights and perspectives missing from recent reports on the clinical research enterprise crisis. This is particularly true in reference to the reports' assessments and recommendations surrounding the second "translation block" - the translation of clinical research findings into routine clinical practice. Furthermore, VHA, ORD, HSR&D and QUERI already offer much of the infrastructure and activity recommended to improve the pipeline. With modest refinements in existing programs and activities, VHA could implement and improve upon the reports' vision, offering national and international leadership in creating an efficient, effective system for developing, refining, vetting and applying research discoveries to maximize benefits to consumers and the delivery system.

Implications:
Policies and programs resulting from ongoing efforts to address the crisis may influence the allocation of billions of dollars of research funds and the research activities of tens of thousands of medical researchers. VHA is unique in combining a large integrated healthcare delivery system with a major internal research program. VHA has a unique ability, and an important obligation, to contribute to the ongoing deliberations and to provide leadership in addressing the crisis.

Impacts:


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