clinical trial finances: juggling the skills of the research coordinator
TRANSCRIPT
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