1. Clinical Trial Finances: Juggling the Skills of the Research Coordinator

2. Objectives To review the industry overview of clinical trials from a historical perspective To identify current trends in the administration of clinical trials To demonstrate and outline best practices of budget development and processes for clinical trial management from a financial perspective To identify clinical trial billing models which mitigate compliance risks

3. Clinical Research vs. Clinical Trial Clinical research- broad set of activities: scientific idea, research questions and design, publish results Clinical trial- pre-defined protocol, limited scientific input from PI towards the research design

4. Drug Approval Overview 100,000 molecules 10,000 compounds 24 pre-clinical 100 drug leads 9 Phase I 7 Phase II 3 Phase III Two (2) drugs become field marketed. Drug leads to approved drug success rate of only 2% NDA filed Source: Abbott Pharmaceuticals

5. Worldwide Clinical Trials Source: Centerwatch Analysis, 2006

6. Industry Paradox New drugs Time consuming and costly; high demands for productivity for new drugs Limited budgets, lower compensation, and very low success rates

7. Site Operations Sites are required to perform at a higher level at lower cost differentials Functions: contract/budget negotiation, recruitment, logistics, and regulatory A JUGGLING ACT! % Growth Rate from 2000 Source: Tufts Center for the Study of Drug Development

8. Trends in Clinical Trial Administration Research Support Services –Office of Compliance –Data Coordinating Center –Research Coordinator Pool Increased training and credentialing Central administration –Clinical Trials Office Regulatory Audit/Monitoring Recruitment Contract Negotiation CLINICAL TRIAL FINANCES!!!

9. Considerations in Clinical Trial Finances Clinical Trial Management Systems Research Infrastructure Clinical Trial Billing Sponsor/CRO Relationships PI/IRB Relationship Incentives for Clinical Investigators Clinical Trial Networks

10. Developing the Clinical Trial Budget Important Questions –Are the scientific value and ethical quality of the study acceptable? –Do I have a adequate pool of potential subjects? –Does the proposed budget support the work described in the protocol? If the answer to any of these questions is no, decline the trial.

11. Clinical Trial Budgeting Important to remember: the budget should reflect the proposed work in the protocol not the sponsor’s proposed budget Review the schedule of visits in the protocol and begin drafting a budget (note: perform this step regardless of whether or not you have received the sponsor’s budget)

12. Identify Costs Hospital Procedures-know the contact for prices; research rates, if any; costs to the research, i.e. charge vs. cost Practice Plan costs-costs as a physician Lab costs-consider location of tests; conceptualize “central laboratory” costs to the research Frequency and duration of study visits-include visits prior to randomization Training-Investigator meeting; coordinator orientation

13. Budgetary Levels Subject Level Study Level

14. Subject Level Procedures by Coordinator, PI, and Hospital Costs/Fees Example: lab draw - Coordinator collects sample - Hospital analyzes sample - PI interprets analysis Assign costs to the ENTIRE procedure Indirect Costs-from 25% to 35%

15. The Coordinator Regulatory Files-electronic and hard copy binders Communication-phone, fax, email Case Report Form-data entry and maintenance Scheduling-subject visits and procedures Sponsor queries Tracking

16. Protocol and Budget Source: University of Mississippi Medical Center

17. Study Level Screening Logs Screen Failures Electronic Data Management Training Recruitment IRB Fees Fees for Pharmacy Set-up Storage Other study visits Additional regulatory submissions (amendments, SAEs) Monitor visits Study initiation (all-inclusive)

18. Source: University of Mississippi Medical Center

19. Sponsor’s Budget Compare with your budget Is Per Subject costs equivalent? Is overhead accurately represented? Are costs at the study level comparable? Review Negotiate-be sure to provide flexibility for re- negotiation

20. Payment Terms Schedule of payments (e.g. annually, quarterly, after CRF completion, after monitor visit) Determine what payments can be invoiced (e.g. invoice for per subject payments, invoice one-time costs)

21. Track Payments Maintain a running financial statement Electronic calendar of when payments are due Prepare invoices for all payments Communicate with Grants and Contracts

22. Clinical Trial Billing Increasing focus of concern from the Centers for Medicare & Medicaid Services (CMS) Rush University Medical Center, December 2005 Appropriate use of research dollars Under-billing more common than over-billing

23. CMS Billing Rules Social Security Act 42 USC § 1395(a)(1)(A) excludes coverage for items and services “which…are not reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member” Payment for investigational items/services generally not permitted Basis for Clinical Trial Policy-National Coverage Decision on Routine Costs of Qualifying Clinical Trials

24. Medicare Coverage Analysis Gather pertinent documents Document all Patient Care Costs Document all Patient Care Costs covered by the Sponsor (i.e. free to you) Determine whether or not study is a Qualifying Clinical Trial Review Routine Care Items

25. Source: University of Mississippi Medical Center

26. Clinical Trial Billing Models Subject level Visit level Mechanism through subject registry/CRMS Dual registration

27. Subject Level Research subjects are identified in the registration system by an electronic flag Bills for these individuals are forced into a separate bill queue which holds the charge until the bil has been reviewed

28. Visit Level All visits for the research are sent to the billing office and preloaded Bills for the preloaded visits are sent to a separate queue and held until the bills have been reviewed

29. Subject Registry CRMS or subject database interfaces with billing system to mark potential study visits-entire process in automated Bills are sent to a separate queue and held until the bills have been reviewed

30. Dual Registration Two discrete registrations are created; one for research charges and one for routine/standard of care charges Bills from research registration are sent to a separate queue and held until the bills have been reviewed

31. Best Practices for Clinical Trial Finances Database of all clinical trials (VCU and VCUHS) Database of all research subjects Automate registration and billing Audit and monitor clinical trial billing Educate PIs, coordinators, and revenue cycle staff

32. Questions Quincy J. Byrdsong qbyrdsong@vcu.edu 6-3343