CommentaryClinical Research

A Radical Proposal: Integrate Clinical Investigation into the U.S. Health Care System

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Science Translational Medicine  28 Oct 2009:
Vol. 1, Issue 4, pp. 4cm4
DOI: 10.1126/scitranslmed.3000296

Figures

  • Fig. 1.

    Better than an apple a day: A robust clinical research enterprise.

    CREDIT: JUPITERIMAGES

Tables

  • Table 1

    Areas of expertise required for the clinical investigator.

    Ability to formulate clinical research topics that focus on important, testable questions
    Ability to review and synthesize the literature
    Ability to design feasible research studies to address the questions
    Ability to implement research protocols
    Ability to recognize and avoid sources of error
    Ability to manage large volumes of clinical data
    • acquisition
    • storage
    • quality control
    Ability to appropriately analyze, interpret, and report research results
    Knowledge about ethical and regulatory issues, including but not limited to
    • informed consent
    • protection of vulnerable research populations
    • adverse event monitoring and reporting
    • compliance with research billing
    • conflicts of interest
    • standards of authorship
  • Table 2

    Separate infrastructure for clinical research.

    Accreditation bodies and standards
    Research record systems
    Human protection methods
    Adverse event–reporting methods
    Compliance programs and offices
    Research billing offices and procedures
    Research contracting offices
    Research financing and accounting
    Conflict of interest procedures

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