Study Budgets: Industry Sponsored Studies Kelsey Richey Center for Clinical Research (CCR)
Learning Objectives • Identify the components of a clinical trial budget • Identify hidden costs
Topic Overview • Budget Development Basics • Components of a Clinical Trial Budget - Subject Costs - Non-Subject Fees/ Admin. Fees/ Contingent Fees • Useful Tips
Budget Development Basics Documents Needed • What you need: - The sponsors budget template - Contract - Protocol • Schedule of Assessments - Informed Consent - May need: • Imaging Manual • Laboratory Manual • Pharmacy Manual
Budget Development Basics Example Internal Budget (see sample legal size template) Center for Clinical Research (CCR) Financial Services Program Investigator: Draft Budget Protocol #: 7-Jul-2016 Sponsor: NUCATS Study #: SP0#: Chart string: Screening Baseline D1 D7 D14 M24 M27 EOS EOT Event Visit 1 2 3 4 5 14 15 16 Total Per Subject Total for 1 Subjects Coordinator: Pat Casey, 1% Effort Informed consent X Elizabeth Kidd, 5% Effort Demography, Height X Medical history X Coordinator MS History/Treatments X Incl/Excl X X Phone interview X X X X X X X Patient diary review X X X Contraception status X X X X X Vital signs, Weight X X X X X X X X Time/Effort Prior/Con Meds X X X X X X X X eCSSRS X X X X X X X X T25FW X X X X X 9HPT X X X X SDMT X X X X MSIS-29 X X X X EQ-5D X X X X WPAI:MS X X X X PRO Completion form X X X X Visit Length ( hours ) 10.0 10.0 5.0 5.0 5.0 10.0 5.0 10.0 3.0 Per Patient Effort (includes benefits) $3,888.29 0.0 # Of Years Effort will be Applied 2.5 0.0 % Future Year Increases 3% 0% Total Coordinator: $ 654.14 $ 654.14 $ 327.07 $ 327.07 $ 327.07 $ 654.14 $ 327.07 $ 654.14 $ 7,522.62 $ 7,522.62 Physician: PI (& Sub-I) Time/Effort Physical Exam Bruce Cohen, 2% Effort X X X X X Per Patient Effort (includes benefits) $7,276.39 # Of Years Effort will be Applied 2.5 0.0 % Future Year Increases 3% 0% Total Physician: $ 1,224.13 $ 1,224.13 $ 612.07 $ 612.07 $ 612.07 $ 1,224.13 $ 612.07 $ 1,224.13 $ 14,077.54 $ 14,077.54 $ - Labs: Central labs (processed by Coord) Labs X X X X X Pregnancy Test 25 25 25 25 25 Subtotal 25.0 0.0 25.0 0.0 0.0 25.0 25.0 25.0 0.0 # Of Years Study will Utilize Lab Services 0.0 % Future Year Increases 0% Total Labs: $ 25.00 $ - $ 25.00 $ - $ - $ 25.00 $ 25.00 $ 25.00 $ 325.00 $ 325.00 $ - NMHC: Radiology ECG X 100 100 100 NMHC (Hospital Fees) MRI 2750 2750 2750 2750 Subtotal 2750.0 100.0 0.0 0.0 0.0 2750.0 0.0 2850.0 2850.0 # Of Years Study will Utilize NMHC 2.5 0.0 % Future Year Increases 3% 0% Total NMHC: $ 2,960.91 $ 107.67 $ - $ - $ - $ 2,960.91 $ - $ 3,068.58 $ 12,058.99 $ 12,058.99 $ 2,850.00 Misc: EDSS 155 X 155 155 155 25 Subtotal 155.0 0.0 0.0 0.0 0.0 155.0 155.0 155.0 25.0 NMG (Professional Fees) # Of Years Study will Utilize NMG 2.5 0.0 % Future Year Increases 3% 0% Total NMG: $ 166.89 $ - $ - $ - $ - $ 166.89 $ 166.89 $ 166.89 $ 1,835.77 $ 1,835.77 $ 50.00 Travel/Stipend/Administration: Subject Stipend Form of payment 25 25 25 25 25 25 25 25 Travel/Stipend/Administration: $ 25.00 $ 25.00 $ 25.00 $ 25.00 $ 25.00 $ 25.00 $ 25.00 $ 25.00 $ 400.00 $ 400.00 $ - Pharmacy Pharmacy: CPT code 150 150 150 150 150 Total Pharmacy: $ - $ - $ 150.00 $ 150.00 $ 150.00 $ 150.00 $ 150.00 $ - $ 1,950.00 $ 1,950.00 $ - Overhead Subtotal Per Patient/Per Visit $ 5,056.08 $ 2,010.95 $ 1,139.14 $ 1,114.14 $ 1,114.14 $ 5,206.08 $ 1,306.03 $ 5,163.75 $ 38,169.93 $ 38,169.93 $ 2,900.00 30% Indirect Cost Rate $ 1,516.82 $ 603.28 $ 341.74 $ 334.24 $ 334.24 $ 1,561.82 $ 391.81 $ 1,549.12 $ 11,450.98 $ 11,450.98 $ 870.00 Total per patient per visit $ 6,572.90 $ 2,614.23 $ 1,480.88 $ 1,448.38 $ 1,448.38 $ 6,767.90 $ 1,697.83 $ 6,712.87 $ 49,620.91 $ 49,620.91 $ 3,770.00 Estimated Number of Subjects: 1 Total Subject Budget (if all 1 subjects are enrolled and remain in the study for the life of the study): $ 49,620.91 Sponsors Budget Offer/Amount in Contract $ 5,777.10 $ 1,362.60 $ 1,377.00 $ 1,425.60 $ 1,425.60 $ 5,801.40 $ 1,659.60 $ 5,728.50 $ 42,375.60
Recommend
More recommend
