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. 7777 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

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 9 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 Center http//:www.uams.edu/rsc Office: (501) 526-6876