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The Role of Regulation in Clinical Trials: An FDA Perspective


FDA Regulates Products ... FDA is All About 'Protection' Protection of Participants in Clinical Research of FDA-regulated Products ... – PowerPoint PPT presentation

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Title: The Role of Regulation in Clinical Trials: An FDA Perspective

The Role of Regulation in Clinical Trials An
FDA Perspective
  • David A. Lepay, MD PhD
  • Senior Advisor for Clinical Science
  • Director, Office for GCP
  • Office of the Commissioner, FDA
  • June 13, 2002

Regulation Benefits vs. Burdens
  • Do we share a common understanding ?
  • Of mission and linkage of regulation to mission
  • Of definitions What is regulation and what is
    required by regulation
  • Of what is being done beyond regulation and why

Regulation Benefits vs. Burdens
  • Is regulation adding value ?
  • Is inconsistency an issue how much and where
  • As clinical research evolves, is regulation
    evolving accordingly and appropriately ?

FDA Regulates Products
  • Drugs, biologics, medical devices (diagnostic and
    therapeutic), foods nearly 25 of the U.S.
  • FDA has responsibility for clinical
    investigations of FDA-regulated products
  • Irrespective of study funding
  • Irrespective of study location within the U.S.
  • Irrespective of whether for commercialization/
    marketing or for scientific knowledge

FDA is All About Protection
  • Protection of Participants in Clinical Research
    of FDA-regulated Products
  • Broad Public Protection Mission
  • To promote safe use of products that are
    themselves safe and efficacious
  • To advance public health through evidence-based
    medicine (and the integrity of research data)

The Value of Clinical Trials in Product Approval
is Recognized
  • Fully 83 of all adults believe it is
    essential (43) or very important (40) that
    all new prescription drugs or other treatments
    should be tested on human beings in clinical
    trials before they are approved for general use
  • Only 1 think it is not important and only 14
    think it is only somewhat important
  • Harris Interactive Survey, March 26, 2002

But Public Confidence is at Issue...
  • Confidence that patients in clinical trials
  • Are treated as patients, not as guinea pigs
  • 24 Very Confident 13 Not Confident
  • Are told honestly and clearly of the risks
  • 25 Very Confident 18 Not Confident
  • Are Not Just Recruited so MDs/Hospitals can Make
    More Money
  • 20 Very Confident 20 Not Confident

Levels of Authority at FDA
  • Law Passed by Congress Governs FDA and the
    U.S. public
  • Regulation Promulgated by FDA to implement the
    law Carries the force of law
  • Guidance FDAs best advice Alternate methods
    may be used to meet regulation

Public Comment and Contribution
  • In general, FDA regulations and guidances are
    initially published as draft for public comment
  • Implementation occurs after review and assessment
    of these comments
  • FDA may also issue an advance notice of proposed
    rule making where the Agency recognizes an
    important concern but wants to first solicit
    comments on the need for regulation or its

Key Regulations Governing the Conduct of Clinical
  • Regulations directed toward protection of human
    research subjects
  • 21 CFR Part 50 Informed Consent
  • 21 CFR Part 56 IRB Regulations
  • These regulations are near-identical to the
    Common Rule (codified in 45 CFR Part 46 and
    elsewhere) which governs protection of subjects
    in federally funded research

Key Regulations Governing the Conduct of Clinical
  • Regulations supporting FDAs unique product
    application review responsibilities and the
    Agencys broad public protection mission
  • 21 CFR Part 312 IND Regulations (drug)
  • 21 CFR Part 812 IDE Regulations (device)
  • 21 CFR Part 314 NDA Regulations (drug)
  • 21 CFR Part 814 PMA Regulations (device)
  • 21 CFR Part 11 Electronic Records/Signatures
  • 21 CFR Part 54 Financial Disclosure

How does FDA Oversee Clinical Research
  • In-house Review Process
  • Applications and amendments
  • Safety reports
  • Annual reports
  • Bioresearch Monitoring Program
  • On-site inspections

Serious Noncompliance has Decreased over Time
n 400
n 15
Compliance as an Evolving Challenge for FDA -1-
  • Sponsor-Investigators
  • Who monitors the study ?
  • Non-U.S. studies
  • How to ensure quality over what FDA can not
    regulate in real-time ?
  • Noncommercial investigations of FDA-regulated

Compliance as an Evolving Challenge for FDA -2-
  • Designing trials so compliance makes sense
  • Protocol design should be as simple as possible
    to promote collection of quality data without
    compromising study objectives
  • Study sites should be consulted to make maximum
    use of indigenous record-keeping systems

Compliance as an Evolving Challenge for FDA -3-
  • Dealing with the growth in large multi-center
  • Effective sharing of information
  • Adequacy of oversight
  • Reducing redundancies
  • Regulation vs. Guidance vs. Anecdote
  • Back to basics

Compliance Alone is Not at the Core of Public
  • From the Harris Survey
  • Distrust of systems of medical care
  • Not unique to clinical trials
  • Too little information or unbalanced information
    (safety risks vs. benefits)
  • Too little communication/transparency
  • Concerns over conflicts of interest
  • Interests of investigator/institution over
    interests of subjects

The Challenges for FDA
  • Upholding and increasing confidence in a system
    that largely works well
  • Understanding, shaping, and adapting to the
    evolution of this system
  • Focusing on quality, capacity, performance, and
    added value
  • Leveraging (resources culture)

FDA is Striving to Meet these Challenges
  • Infrastructure
  • Initiatives
  • Collaboration
  • Communication