New Faculty Orientation August 22, 2012 UAMS Research Support Center Director: Tom Wells

1. New Faculty Orientation August 22, 2012 UAMS Research Support Center Director: Tom Wells (501) 603-1638 wellsthomasg@uams.edu

2. 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

3. 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

4. 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

5. 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

6. 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.

7. 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 7 7 7 7 Zarin DA, NLM Presentation, October 2009

8. 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

9. 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

10. 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

11. 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

12. Questions?Research Support Centerhttp//:www.uams.edu/rscOffice: (501) 526-6876