New Faculty OrientationAugust 22, 2012

UAMS Research Support CenterDirector: Tom Wells

(501) 603-1638wellsthomasg@uams.edu

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

• 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.

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Public Law 110-85Sec.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

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

9Zarin DA, NLM Presentation, October 2009

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 Centerhttp//:www.uams.edu/rscOffice: (501) 526-6876