Clinical Trial Finances: Juggling the Skills of the Research Coordinator

Clinical Trial Finances: Juggling the Skills of the Research Coordinator

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

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

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

Worldwide Clinical Trials

0

10000

20000

30000

40000

50000

60000

70000

2000 2001 2002 2003 2004 2005 2006

# of PhaseI-III clinicaltrials

Source: Centerwatch Analysis, 2006

Industry Paradox

• New drugs• Time consuming and

costly; high demands for productivity for new drugs

• Limited budgets, lower compensation, and very low success rates

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!-2

0

2

4

6

8

10

12

# of complexprocedures

frequency ofprocedures

compliance compensationper procedure

% Growth Rate from 2000

Source: Tufts Center for the Study of Drug Development

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!!!

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

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.

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)

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

Budgetary Levels

• Subject Level

• Study Level

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%

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

Protocol and Budget

Study Period Washout ScreeningVisit 1 2 3 4 5 6 7 8

PROCEDURES: -21 -14 1 7 14 28 42 56Informed Consent $75 $75 $75Inclusion/Exclusion Criteria $25 $25 $25 $25 $75Taper AntiHyp Meds $40 $40 $40Medical History (inc. Hyp & Smoking $85 $85 $85Height/ Weight $15 $15 15Waist Circumference $15 $15 $15BP and Pulse $25 $25 $25 $25 $25 $25 $25 $25 $25 $200Screening PE $125 $125 $125Complete PE $175 $175 $175 $350EKG $63 $63 $63 $63 $189EKG Interpretation $37 $37 $37 $37 $111Collect Labs $25 $25 $25 $25 $25 $100Lab Interpretation $25 $25 $25 $25 $25 $100Pharmacogenetic Consent $25 $25 $25Adverse Events $20 $20 $20 $20 $20 $20 $20 $20 $140Concomitant Medications $15 $15 $15 $15 $15 $15 $15 $15 $15 $120Drug Accountability $25 $25 $25 $25 $25 $25 $25 $150IVRS $40 $40 $40 $40 $40 $160Screening Log $25 $25 $25Randomization $25 $25 $25Dispense Study Meds $20 $20 $20 $20 $60Echocardiagram $40 $40 $40Pt Reimbursement for Travel $25 $25 $25 $25 $25 $25 $25 $25 $25 $200Coordinator Fee: $60 $60 $60 $60 $60 $60 $60 $60 $60 $480

Total per procedure $650 $230 $660 $230 $170 $220 $170 $575 $2,905Institutional overhead 26% $169 $60 $172 $60 $44 $57 $44 $150 $755

Total w/ overhead $819 $290 $832 $290 $214 $277 $214 $725 $3,6609 Patients: $32,942.70

Totals

Double-blind Treatment Period

Cost

Source: University of Mississippi Medical Center

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)

Study PeriodVisit 1 2 3 4 5 6 7 8

PROCEDURES: -21 -14 1 7 14 28 42 56Informed Consent $75 $75 $75Inclusion/Exclusion Criteria $25 $25 $25 $25 $75Taper AntiHyp Meds $40 $40 $40Medical History $85 $85 $85Height/ Weight $15 $15 15Waist Circumference $15 $15 $15BP and Pulse $25 $25 $25 $25 $25 $25 $25 $25 $25 $200Screening PE $125 $125 $125Complete PE $175 $175 $175 $350EKG $63 $63 $63 $63 $189EKG Interpretation $37 $37 $37 $37 $111Collect Labs $25 $25 $25 $25 $25 $100Lab Interpretation $25 $25 $25 $25 $25 $100Pharmacogenetic Consent $25 $25 $25Adverse Events $20 $20 $20 $20 $20 $20 $20 $20 $140Concomitant Medications $15 $15 $15 $15 $15 $15 $15 $15 $15 $120Drug Accountability $25 $25 $25 $25 $25 $25 $25 $150IVRS $40 $40 $40 $40 $40 $160Screening Log $25 $25 $25Randomization $25 $25 $25Dispense Study Meds $20 $20 $20 $20 $60Echocardiagram $40 $40 $40Pt Reimbursement for Travel $25 $25 $25 $25 $25 $25 $25 $25 $25 $200Coordinator Fee: $60 $60 $60 $60 $60 $60 $60 $60 $60 $480

Total per procedure $650 $230 $660 $230 $170 $220 $170 $575 $2,905Institutional overhead 26% $169 $60 $172 $60 $44 $57 $44 $150 $755

Total w/ overhead $819 $290 $832 $290 $214 $277 $214 $725 $3,6609 Patients: $32,942.70

STUDY LEVEL COSTS:Screen Failures 6 $1,108.80 $6,652.80Electronic Data Capture Support 24 $40.00 $960.00Advertising/Recruitment $3,000.00Study Initiation $3,250.00IRB Fee $2,000.00Unscheduled Visits 13 9 $85.00 per visit $9,945.00Pharmacy Set Up Fee $500.00Storage Fee $450.00TOTAL INVOICED COSTS: $26,757.80

$59,700.50Total Requested:

hours at per hour

visits per patient, up to: patients at

Totals

Double-blind Treatment Period

Cost

Maximum of Failures at

Source: University of Mississippi Medical Center

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

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)

Track Payments

• Maintain a running financial statement

• Electronic calendar of when payments are due

• Prepare invoices for all payments

• Communicate with Grants and Contracts

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

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

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

Study PeriodVisit 1 2 3 4 5 6 7 8

PROCEDURES: -21 -14 1 7 14 28 42 56Informed Consent $75 $75 $75Inclusion/Exclusion Criteria $25 $25 $25 $25 $75Taper AntiHyp Meds $40 $40 $40Medical History $85 $85 $85Height/ Weight $15 $15 15Waist Circumference $15 $15 $15BP and Pulse $25 $25 $25 $25 $25 $25 $25 $25 $25 $200Screening PE $125 $125 $125Complete PE $175 $175 $175 $350EKG $63 $63 $63 $63 $189EKG Interpretation $37 $37 $37 $37 $111Collect Labs $25 $25 $25 $25 $25 $100Lab Interpretation $25 $25 $25 $25 $25 $100Pharmacogenetic Consent $25 $25 $25Adverse Events $20 $20 $20 $20 $20 $20 $20 $20 $140Concomitant Medications $15 $15 $15 $15 $15 $15 $15 $15 $15 $120Drug Accountability $25 $25 $25 $25 $25 $25 $25 $150IVRS $40 $40 $40 $40 $40 $160Screening Log $25 $25 $25Randomization $25 $25 $25Dispense Study Meds $20 $20 $20 $20 $60Echocardiagram $40 $40 $40Pt Reimbursement for Travel $25 $25 $25 $25 $25 $25 $25 $25 $25 $200Coordinator Fee: $60 $60 $60 $60 $60 $60 $60 $60 $60 $480

Total per procedure $650 $230 $660 $230 $170 $220 $170 $575 $2,905Institutional overhead 26% $169 $60 $172 $60 $44 $57 $44 $150 $755

Total w/ overhead $819 $290 $832 $290 $214 $277 $214 $725 $3,6609 Patients: $32,942.70

STUDY LEVEL COSTS:Screen Failures 6 $1,108.80 $6,652.80Electronic Data Capture Support 24 $40.00 $960.00Advertising/Recruitment $3,000.00Study Initiation $3,250.00IRB Fee $2,000.00Unscheduled Visits 13 9 $85.00 per visit $9,945.00Pharmacy Set Up Fee $500.00Storage Fee $450.00TOTAL INVOICED COSTS: $26,757.80

$59,700.50Total Requested:

hours at per hour

visits per patient, up to: patients at

Totals

Double-blind Treatment Period

Cost

Maximum of Failures at

Source: University of Mississippi Medical Center

Clinical Trial Billing Models

• Subject level• Visit level• Mechanism through

subject registry/CRMS

• Dual registration

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

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

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

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

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

Questions

Quincy J. Byrdsong

qbyrdsong@vcu.edu

6-3343