Evaluation of a Protocol Budget
Evaluation of a Protocol Budget
Evaluation of a Protocol Budget
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<strong>Evaluation</strong> <strong>of</strong> a <strong>Protocol</strong> <strong>Budget</strong><br />
Margaret Matula, R.N., M.G.A.<br />
Director<br />
Research & Clinical Trials<br />
Anne Arundel Medical Center<br />
Annapolis, MD<br />
IPPCR 12/15/09 Slide # 1
Introduction<br />
• Determine requirements:<br />
∗ <strong>Protocol</strong><br />
∗ Site resources<br />
• Establish protocol budget<br />
IPPCR 12/15/09 Slide # 2
Sample <strong>Protocol</strong><br />
Phase 3, open label, randomized<br />
study comparing virologic v<br />
response to NNRTI-based vs.<br />
PI-based ART in treatment<br />
naïve women.<br />
IPPCR 12/15/09 Slide # A
Sample <strong>Protocol</strong><br />
Trial 1<br />
Women w/ prior SD NVP<br />
exposure for PMTCT<br />
N = 240<br />
Trial 2<br />
Women with no prior<br />
NVP exposure<br />
N = 400<br />
Randomize 1:1<br />
Arm 1A<br />
• NVP QD x14D then BID<br />
• TDF QD<br />
• FTC QD<br />
Arm 1B<br />
• LVP/RTV BID<br />
• TDF QD<br />
• FTC QD<br />
IPPCR 12/15/09 Slide # B
Requirements<br />
<strong>Protocol</strong><br />
• Eligibility<br />
• Schedule<br />
• Investigator’s<br />
Brochure<br />
• Lab Manual<br />
• Contract Terms<br />
Site<br />
• Personnel<br />
• Equipment<br />
• Toxicity<br />
Management<br />
• Research vs.<br />
SOC<br />
IPPCR 12/15/09 Slide # 3
Duration<br />
• Study intervention<br />
• Follow-up<br />
IPPCR 12/15/09 Slide # 5
Subjects<br />
<strong>Protocol</strong><br />
• Enrollment<br />
• Screening<br />
• Eligibility Criteria<br />
• # <strong>of</strong> Visits<br />
Site<br />
• Population Base<br />
∗ Size<br />
∗ Minorities<br />
∗ Women<br />
∗ Children<br />
∗ Other special<br />
groups<br />
IPPCR 12/15/09 Slide # 6
Site<br />
Subjects<br />
• Recruitment and Retention<br />
∗ Strategy / Plan<br />
women & minorities<br />
∗ Advertising<br />
primary care providers<br />
mailings<br />
∗ Incentives<br />
∗ Tracking<br />
∗ IRB Approval<br />
IPPCR 12/15/09 Slide # 9
<strong>Protocol</strong><br />
Screening<br />
• Clinical <strong>Evaluation</strong>s<br />
• Laboratory <strong>Evaluation</strong>s<br />
• Time Constraints<br />
Site<br />
• Standard <strong>of</strong> Care<br />
• Contract<br />
• <strong>Budget</strong><br />
IPPCR 12/15/09 Slide # 11
<strong>Protocol</strong><br />
• Study Visits<br />
∗ # and length<br />
∗ Exams<br />
Clinical<br />
• Inpatient<br />
• Special Procedures<br />
∗ # and type<br />
Site<br />
• Staff Expertise<br />
• Other Departments<br />
IPPCR 12/15/09 Slide # 12
Location<br />
• Single / Multi-site<br />
• Urban / Rural<br />
• Domestic / International<br />
• University / Private / Public<br />
IPPCR 12/15/09 Slide # 14
• Existing Space<br />
∗ Clinical<br />
∗ Laboratory<br />
∗ Office<br />
∗ Other units<br />
Infrastructure<br />
• Renovations / Alterations<br />
• Consistent<br />
‣ Immunology<br />
‣ Virology<br />
IPPCR 12/15/09 Slide # 15
<strong>Protocol</strong><br />
• Tests: # and type<br />
• Specimens<br />
∗ Processing<br />
∗ Shipping<br />
∗ Storage<br />
• Location<br />
• Serial studies<br />
Laboratory<br />
Site<br />
• Preparation<br />
∗ Serum / Tissue<br />
• Shipping<br />
∗ Dry Ice<br />
∗ Transportation<br />
• Storage<br />
∗ Freezer<br />
∗ Retrieval<br />
IPPCR 12/15/09 Slide # 16
Study Product<br />
<strong>Protocol</strong><br />
• Administration<br />
• #<br />
• Route<br />
Site<br />
• Management<br />
∗ Dispensing<br />
∗ Accountability<br />
• Storage<br />
• Subject<br />
∗ Education<br />
∗ Counseling<br />
IPPCR 12/15/09 Slide # 18
<strong>Protocol</strong><br />
• Treatment &<br />
<strong>Evaluation</strong><br />
∗ Additional Visits<br />
∗ Additional Labs<br />
• Reporting<br />
∗ Sponsor<br />
∗ OHRP<br />
∗ FDA<br />
• Follow-up<br />
Toxicity<br />
Site<br />
• Indemnification?<br />
• Billable?<br />
• Follow-up needs?<br />
• Reporting<br />
• <strong>Budget</strong> item?<br />
IPPCR 12/15/09 Slide # 20
Data<br />
<strong>Protocol</strong><br />
• CRFs<br />
∗ Development<br />
• Per Visit<br />
∗ # Forms<br />
∗ # Pages<br />
• Quality<br />
• Submission<br />
Site<br />
• Staff<br />
∗ Completion<br />
∗ QC & QA<br />
∗ Entry<br />
∗ PI sign-<strong>of</strong>f?<br />
• Equipment<br />
∗ PC<br />
∗ Fax<br />
IPPCR 12/15/09 Slide # 21
• Clinical<br />
Monitoring<br />
∗ Adherence to protocol<br />
∗ Adherence to regulatory & GCP<br />
• Safety<br />
∗ SAE reporting<br />
• Data<br />
∗ Source documentation<br />
∗ Endpoints<br />
• Time commitment<br />
IPPCR 12/15/09 Slide # 23
Meetings<br />
<strong>Protocol</strong><br />
• Location<br />
• Training<br />
• Number<br />
• Staff<br />
∗ Investigator<br />
∗ Coordinator<br />
Site<br />
• Travel Expenses<br />
• Time<br />
• Field<br />
∗ Outreach<br />
∗ Other sites<br />
IPPCR 12/15/09 Slide # 24
Personnel<br />
• Experience<br />
• Commitments<br />
∗ Other research<br />
∗ Faculty<br />
∗ Attending<br />
• Investigator<br />
• Coordinator<br />
• Research Nurses<br />
• Laboratory<br />
• Data Staff<br />
• Statistician<br />
IPPCR 12/15/09 Slide # 26
Personnel continued…<br />
• Clinical:<br />
∗ Physicians<br />
∗ Mid-level<br />
providers<br />
∗ Nurses<br />
∗ Pharmacist<br />
• Specialists /<br />
Consultants<br />
• Social Worker<br />
• Monitor<br />
• Quality<br />
• Regulatory<br />
• Administration:<br />
∗ Fiscal<br />
∗ Secretarial<br />
• Other<br />
IPPCR 12/15/09 Slide # 28
Equipment and Supplies<br />
• Clinical<br />
• Laboratory<br />
∗ Freezers<br />
∗ Centrifuge<br />
• Office<br />
∗ Computers<br />
∗ Furniture<br />
∗ Mailing / Shipping<br />
∗ Phone / Fax / Internet<br />
IPPCR 12/15/09 Slide # 30
Institution<br />
• Institutional Review Board (IRB)<br />
• Policies & Procedures<br />
• Training<br />
• Regulatory<br />
∗ Federal<br />
∗ NIH Policies<br />
∗ Good Clinical Practice (GCP)<br />
IPPCR 12/15/09 Slide # 32
• Other Sites<br />
• Monitoring<br />
• Pharmacy<br />
• Laboratory<br />
Subcontracts<br />
• Data Management<br />
• Record Storage<br />
• Equipment maintenance<br />
IPPCR 12/15/09 Slide # 33
Indirect Costs — Site Requirements<br />
• Facilities & Administration<br />
∗ Overhead<br />
utilities<br />
cleaning<br />
maintenance<br />
∗ % <strong>of</strong> direct costs<br />
personnel<br />
equipment<br />
IPPCR 12/15/09 Slide # 34
IPPCR 12/15/09 Slide # 36
Establishing a <strong>Protocol</strong> <strong>Budget</strong><br />
• Information for prices / costs<br />
∗ Experience<br />
∗ Industry standard<br />
∗ ?<br />
• Include<br />
∗ Start-up<br />
∗ Screening & Follow-up<br />
∗ Close-out<br />
out<br />
IPPCR 12/15/09 Slide # 37
Establishing a <strong>Budget</strong> continued…<br />
• Conserve costs while preserving<br />
safety and scientific integrity<br />
∗ Necessary<br />
∗ Negotiate rates<br />
∗ Subcontract<br />
IPPCR 12/15/09 Slide # 38
Establishing a <strong>Budget</strong> continued…<br />
• Determine how costs will be charged<br />
∗ Personnel<br />
hourly rate<br />
% time & benefits<br />
per study visit<br />
∗ Labs<br />
real time / batched<br />
storage<br />
IPPCR 12/15/09 Slide # 39
Establishing a <strong>Budget</strong> continued…<br />
Determine the REAL cost <strong>of</strong><br />
conducting a protocol<br />
IPPCR 12/15/09 Slide # 40
Establishing a <strong>Budget</strong> continued…<br />
• Line item for each resource<br />
• Cost per patient<br />
∗ Spreadsheet<br />
∗ Subtotal categories<br />
IPPCR 12/15/09 Slide # 41
<strong>Protocol</strong> Schedule<br />
HIV<br />
doc<br />
HX<br />
Con<br />
Med<br />
Sc 0<br />
X<br />
X<br />
2<br />
W<br />
4<br />
W<br />
8<br />
W<br />
12<br />
W<br />
16<br />
W<br />
24<br />
W<br />
36<br />
W<br />
48<br />
W<br />
p<br />
48<br />
W<br />
VF<br />
Step<br />
2<br />
Med X X X X X X X X X 12 X X<br />
PE X X X X X X X X X X 12 X X<br />
Hem X X X X X X X 12 X X<br />
Chem X X X X X X X 12 X X<br />
Lipid X X X 48 X X<br />
DC<br />
IPPCR 12/15/09 Slide # 42
<strong>Protocol</strong> Schedule<br />
Sc 0<br />
2<br />
W<br />
4 W 8<br />
W<br />
12<br />
W<br />
16<br />
W<br />
24<br />
W<br />
36<br />
W<br />
48<br />
W<br />
p<br />
48<br />
W<br />
VF<br />
Step<br />
2<br />
LFTs X X X X X X X X X X 12 X X<br />
Preg<br />
HbSAg<br />
Lipase<br />
CPK<br />
Lactate<br />
X X<br />
X<br />
Repeat as indicated<br />
Perform if sx <strong>of</strong> pancreatitis<br />
Perform if sx <strong>of</strong> myositis<br />
Perform if sx <strong>of</strong> lactic acidosis<br />
CD4 / 8 X X X X X X 12 X X<br />
DC<br />
IPPCR 12/15/09 Slide # 43
HIV<br />
RNA-rt<br />
HIV<br />
RNA<br />
Sc 0<br />
<strong>Protocol</strong> Schedule<br />
2<br />
W<br />
4<br />
W<br />
8<br />
W<br />
12<br />
W<br />
16<br />
W<br />
24<br />
W<br />
36<br />
W<br />
48<br />
W<br />
p<br />
48<br />
W<br />
VF<br />
Step<br />
2<br />
rt X X X X X X 12 X X X<br />
RNA-b X X<br />
Plasma<br />
resist<br />
resist X X X<br />
Store<br />
Plasma<br />
Plasma X X X X X X X X X 12 X X X<br />
Store<br />
PBMC<br />
PBMC X X X X X X X 24<br />
PK X X<br />
Adher X X X X 24<br />
QOL/RU X X 24<br />
24 X<br />
DC<br />
IPPCR 12/15/09 Slide # 44
Year 1 – Personnel<br />
IPPCR 12/15/09 Slide # 45
Year 1 – Routine Labs<br />
IPPCR 12/15/09 Slide # 46
Year 1 – “Ology” Labs<br />
IPPCR 12/15/09 Slide # 47
Cost Coversheet<br />
IPPCR 12/15/09 Slide # 48
Summary<br />
<strong>Protocol</strong><br />
• Schedule<br />
• Conserve Costs<br />
∗ Preserve safety &<br />
science<br />
∗ Necessary not<br />
interesting<br />
Site<br />
• Determine Costs<br />
• Develop <strong>Budget</strong><br />
• Accounting<br />
System:<br />
∗ Expenses<br />
∗ Invoicing<br />
∗ Revenue<br />
IPPCR 12/15/09 Slide # 49
Contact<br />
Margaret Matula<br />
e-mail: mmatula@aahs.org<br />
IPPCR 12/15/09 Slide # 50
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