Clinical Research vs. Practice of Medicine

New Faculty Orientation
UAMS Research Support Center
Director: Tom Wells
(501) 603-1638
[email protected]
Research Support Center
• Lawrence E. Cornett, PhD, Vice Chancellor for
Research
• Tom Wells, MD, MBA, Director
• Carole Hamon, BS, Associate Director
• Julia Washam, RN, Associate Director
Research Support Center Services
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Protocol development and review
Regulatory review and support (FDA)
Quality assurance (GMP, GLP)
Monitoring, DSMP, DSMB
Clinical trials registration
Budget review and assistance with budget
development
• Medicare coverage analysis
• Contract review, negotiation, and approval
Three Topics to Consider When
Planning Your Research
• Research vs. the practice of medicine
• Coverage analysis for tests and procedures in
research studies
• Clinical trial registration
Clinical Research vs.
Practice of Medicine
• FDA does not regulate the practice of medicine
• Arkansas State Medical Board does not regulate clinical
research
• For clinical care, physicians may prescribe “off-label” any
approved drug, biological, or medical device
• Approved drugs used in a new population or for a new
indication may require an IND if used in research
• Unapproved drugs and biologicals used in research
require an IND or an exemption
• Unapproved devices used in clinical research require an
IDE or other clearance from the FDA
Coverage Analysis
• Coverage analysis is a determination, based on CMS
rules, as to whether or not services that are normally
billable to patients can be charged to subjects enrolled
in a research study.
• Third party payors may or may not pay for services that
are provided as part of a research study even if those
same services would be billable as part of routine care
if the subject was not a research participant.
• At UAMS, all research studies that include medical
procedures, drugs, clinic visits, or laboratory studies
must undergo coverage analysis.
Public Law 110-85
Sec.801 Expanded Clinical Trial Registry
• Enacted on September 27, 2007
• Requires Trial Registration (Dec 2007)
– Phase II-IV drug and device trials for all diseases
– Data elements: ClinicalTrials.gov + WHO/ICMJE
• Requires Results Reporting (Sept 2008)
– Trials of FDA-approved or cleared drugs and devices
– “Basic” Results: Baseline Characteristics, Primary &
Secondary Outcomes, Statistical Analyses
– Adverse Events (Sept 2009)
– “Expansion” of results by rulemaking (Sept 2010)
• Added enforcement provisions
Zarin DA, NLM Presentation, October 2009
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Enforcement Provisions
• Notices of non-compliances
• Civil monetary penalties up to $10,000/day
• Withholding of NIH grant funds
Zarin DA, NLM Presentation, October 2009
ICMJE Policy
• Editorial 2004 and updates
• Registration required for manuscript
consideration for following:
– Interventional studies
– Any phase
– Any intervention
• ClinicalTrials.gov or WHO Primary registry
• Registration prior to enrollment first
participant
Zarin DA, NLM Presentation, October 2009
9
Clinical Trials Registration at UAMS
• The sponsor is required to register the trial
– Industry-sponsored and cooperative group trials
will be registered by outside entities (sponsors)
– Investigator-initiated trials meeting the above
criteria must be registered by UAMS (and the PI)
– RSC will help with registration
• If not registered properly, you may not be able
to publish your data
Final Thoughts
• Contact us if you are going to conduct
investigator-initiated research
• Research is NOT the practice of medicine; the
regulatory requirements are different
• We are not the Institutional Review Board nor
are we Research Compliance
• We are here to assist you in getting your
research up and running correctly
Questions?
Research Support Center
http//:www.uams.edu/rsc
Office: (501) 526-6876