NIH ROADMAP FOR MEDICAL RESEARCH

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NIH ROADMAP FOR MEDICAL RESEARCH

• RE-ENGINEERING THE CLINICAL RESEARCH ENTERPRISE

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Reengineering the Clinical Research Enterprise
Goal Re-energize the clinical research workforce
and enhance the infrastructure and capacity for
clinical research.

• Enhance training for clinical researchers
• Support translational research
• Improve subjective assessment of clinical
  outcomes
• Integrate existing clinical research networks and
  informatics
• Coordinate and improve regulatory policy and
  requirements

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NIH Clinical Research Career Development
Programs
College Professional Post-Doc Prof.
Advancement Grad School
Doubled the NIH Clinical Center Clinical Research
Training Program in FY04
Pre-doctoral Clinical Research Training Program
(RFA in FY05)
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Multidisciplinary Clinical Research Career
Development Program

• Features
• Formal training in the discipline of clinical
  research
• Apprenticeship in mentored multi-disciplinary
  team setting
• Shared research support facility and project
  support
• Flexible salary support for Scholars and mentors
• Coordinated national program
• Status
• Funded 7 programs in FY04, and new RFA for FY05

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Translational Research

• Regional Translational Research Centers
• Clinical services (statistical, regulatory, data
  management, patient recruitment, pilot projects,
  etc..) provided regionally
• Core technologies provided nationally
• Combined centers
• Status
• RFA for planning grants FY05-06 (20/yr)
• Centers to be funded FY06-08
• NIH Rapid Access to Intervention Development (NIH
  RAID)
• For FY05

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PROMIS Patient-Reported Outcomes Measurement
Information System

• Goal
• Develop item banks and computerized adaptive
  testing to improve assessment of self-reported
  symptoms and health-related quality of life
  across a wide range of chronic diseases
• Status
• Funded data coordinating center and 6
  collaborating research sites in FY04

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Integration of Clinical Research Networks and
Informatics

• Link existing networks so clinical studies and
  trials can be conducted more effectively
• Ensure that patients, physicians, and scientists
  form true Communities of Research
• Status Funded in FY04
• Contract to inventory networks and evaluate best
  practices
• BAA to integrate and expand existing networks,
  and improve interoperable informatics backbone

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Coordinate and Improve Policies and Requirements
for Clinical Research

• Goals
• Clear, effective, coordinated rules, regulations,
  and policies
• Efficient dissemination and utilization of
  research results
• Maximally effective human subjects protections
• A solid foundation for public trust
• Status
• Created Clinical Research Policy Analysis and
  Coordination Program within the Office of Science
  Policy
• Working with federal agencies and research
  communities to catalyze the federal-wide
  coordination of policies pertaining to clinical
  research
• Developing tools and resources to facilitate
  understanding of and compliance with policies and
  requirements