Transcript 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 researchbroad set of activities:
scientific idea,
research questions
and design, publish
results
• Clinical trialpre-defined protocol,
limited scientific input
from PI towards the
research design
Drug Approval Overview
100 drug leads
24 pre-clinical
9 Phase I
100,000
molecules
10,000
compounds
7 Phase II
3 Phase III
Two (2) drugs become
field marketed.
NDA filed
Source: Abbott Pharmaceuticals
Drug leads to approved
drug success rate of
only 2%
Worldwide Clinical Trials
70000
60000
50000
40000
# of Phase
I-III clinical
trials
30000
20000
10000
0
2000 2001 2002 2003 2004 2005 2006
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!
% Growth Rate from 2000
12
10
8
6
4
2
0
-2
# of complex
procedures
frequency of
procedures
compliance
compensation
per procedure
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
Visit
PROCEDURES:
Informed Consent
Inclusion/Exclusion Criteria
Taper AntiHyp Meds
Medical History (inc. Hyp & Smoking
Height/ Weight
Waist Circumference
BP and Pulse
Screening PE
Complete PE
EKG
EKG Interpretation
Collect Labs
Lab Interpretation
Pharmacogenetic Consent
Adverse Events
Concomitant Medications
Drug Accountability
IVRS
Screening Log
Randomization
Dispense Study Meds
Echocardiagram
Pt Reimbursement for Travel
Coordinator Fee:
Total per procedure
Institutional overhead
Total w/ overhead
Cost
$75
$25
$40
$85
$15
$15
$25
$125
$175
$63
$37
$25
$25
$25
$20
$15
$25
$40
$25
$25
$20
$40
$25
$60
26%
Washout Screening
1
2
-21
-14
$75
$25
$25
$40
$85
$25
$125
$25
Double-blind Treatment Period
4
5
6
7
7
14
28
42
$25
$15
$15
$25
$25
$40
$175
$63
$37
$25
$25
$25
$20
$15
$25
$40
$20
$15
$25
$40
$20
$25
$20
$20
$25
$60
$230
$60
$290
$25
$60
$660
$172
$832
$25
$60
$230
$60
$290
$63
$37
$25
$25
$15
3
1
$20
$15
$25
$25
$25
$25
$25
$20
$15
$25
$20
$15
$25
$20
$15
$25
$25
$60
$170
$44
$214
$25
$60
$220
$57
$277
$25
$60
$170
$44
$214
9
$25
$25
$60
$650
$169
$819
8
56
Totals
$75
$75
$40
$85
15
$15
$25
$200
$125
$175
$350
$63
$189
$37
$111
$25
$100
$25
$100
$25
$20
$140
$15
$120
$25
$150
$40
$160
$25
$25
$60
$40
$40
$25
$200
$60
$480
$575
$2,905
$150
$755
$725
$3,660
Patients: $32,942.70
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 Period
Visit
PROCEDURES:
Informed Consent
Inclusion/Exclusion Criteria
Taper AntiHyp Meds
Medical History
Height/ Weight
Waist Circumference
BP and Pulse
Screening PE
Complete PE
EKG
EKG Interpretation
Collect Labs
Lab Interpretation
Pharmacogenetic Consent
Adverse Events
Concomitant Medications
Drug Accountability
IVRS
Screening Log
Randomization
Dispense Study Meds
Echocardiagram
Pt Reimbursement for Travel
Coordinator Fee:
Total per procedure
Institutional overhead
Total w/ overhead
1
-21
$75
$25
$40
$85
2
-14
Cost
$75
$25
$25
$40
$85
$15
$15
$25 $25 $25
$125 $125
$175
$63 $63
$37 $37
$25 $25
$25 $25
$25
$20
$20
$15 $15 $15
$25
$40
$40
$25 $25
$25
$20
$20
$40
$25 $25 $25
$60 $60 $60
$650 $230
26% $169 $60
$819 $290
3
1
Double-blind Treatment Period
4
5
6
7
7
14
28
42
$25
$15
$15
$25
$25
$175
$63
$37
$25
$25
$25
$20
$15
$25
$40
$20
$15
$25
$40
$25
$20
$20
$25
$60
$660
$172
$832
$25
$60
$230
$60
$290
$25
$25
$25
$25
$20
$15
$25
$20
$15
$25
$25
$60
$170
$44
$214
$25
$60
$220
$57
$277
STUDY LEVEL COSTS:
Maximum of 6
Failures at
Screen Failures
$1,108.80
hours at
Electronic Data Capture Support
24
$40.00 per hour
Advertising/Recruitment
Study Initiation
IRB Fee
patients at
Unscheduled Visits
13 visits per patient, up to: 9
Pharmacy Set Up Fee
Storage Fee
TOTAL INVOICED COSTS:
8
56
Totals
$75
$75
$40
$85
15
$15
$25
$25
$200
$125
$175
$350
$63
$189
$37
$111
$25
$100
$25
$100
$25
$20
$20
$140
$15
$15
$120
$25
$25
$150
$40
$160
$25
$25
$60
$40
$40
$25
$25
$200
$60
$60
$480
$170
$575
$2,905
$44
$150
$755
$214
$725
$3,660
9
Patients: $32,942.70
$6,652.80
$960.00
$3,000.00
$3,250.00
$2,000.00
$85.00 per visit $9,945.00
$500.00
$450.00
$26,757.80
Total Requested: $59,700.50
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 renegotiation
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 Period
Visit
PROCEDURES:
Informed Consent
Inclusion/Exclusion Criteria
Taper AntiHyp Meds
Medical History
Height/ Weight
Waist Circumference
BP and Pulse
Screening PE
Complete PE
EKG
EKG Interpretation
Collect Labs
Lab Interpretation
Pharmacogenetic Consent
Adverse Events
Concomitant Medications
Drug Accountability
IVRS
Screening Log
Randomization
Dispense Study Meds
Echocardiagram
Pt Reimbursement for Travel
Coordinator Fee:
Total per procedure
Institutional overhead
Total w/ overhead
1
-21
$75
$25
$40
$85
2
-14
Cost
$75
$25
$25
$40
$85
$15
$15
$25 $25 $25
$125 $125
$175
$63 $63
$37 $37
$25 $25
$25 $25
$25
$20
$20
$15 $15 $15
$25
$40
$40
$25 $25
$25
$20
$20
$40
$25 $25 $25
$60 $60 $60
$650 $230
26% $169 $60
$819 $290
3
1
Double-blind Treatment Period
4
5
6
7
7
14
28
42
$25
$15
$15
$25
$25
$175
$63
$37
$25
$25
$25
$20
$15
$25
$40
$20
$15
$25
$40
$25
$20
$20
$25
$60
$660
$172
$832
$25
$60
$230
$60
$290
$25
$25
$25
$25
$20
$15
$25
$20
$15
$25
$25
$60
$170
$44
$214
$25
$60
$220
$57
$277
STUDY LEVEL COSTS:
Maximum of 6
Failures at
Screen Failures
$1,108.80
hours at
Electronic Data Capture Support
24
$40.00 per hour
Advertising/Recruitment
Study Initiation
IRB Fee
patients at
Unscheduled Visits
13 visits per patient, up to: 9
Pharmacy Set Up Fee
Storage Fee
TOTAL INVOICED COSTS:
8
56
Totals
$75
$75
$40
$85
15
$15
$25
$25
$200
$125
$175
$350
$63
$189
$37
$111
$25
$100
$25
$100
$25
$20
$20
$140
$15
$15
$120
$25
$25
$150
$40
$160
$25
$25
$60
$40
$40
$25
$25
$200
$60
$60
$480
$170
$575
$2,905
$44
$150
$755
$214
$725
$3,660
9
Patients: $32,942.70
$6,652.80
$960.00
$3,000.00
$3,250.00
$2,000.00
$85.00 per visit $9,945.00
$500.00
$450.00
$26,757.80
Total Requested: $59,700.50
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
[email protected]
6-3343