NCI National Clinical Trials Network (NCTN) Program Guidelines
NCI National Clinical Trials Network (NCTN) Program Guidelines NCI National Clinical Trials Network (NCTN) Program Guidelines
PART 4: Appendices Section IV – Cost Components for Budget Preparation for Network Group Ops & SDMC Centers, Lead Academic Sites, & Canadian Trials Network TOTAL COST BUDGET FOR INFRASTRUCTURE FOR PEDIATRIC NETWORK GROUP (OPERATIONS CENTER & SDMC) # Patients Enrolled on Network Group Trials - High-Performance Intervention Trials 2,800 # Patients Enrolled on Network Group Trials - Advanced Imaging Interventions 104 # Patients Enrolled on Network Group Trials - Basic Intervention (including Pilot and Hx) 1,300 # Patients Enrolled on Network Group Trials - All Intervention Studies 4,204 # Patients Enrolled with Biospecimen Collection # Patients Enrolled for Screening Only # Patients Enrolled on All Non-Intervention Studies (Biospecimens & Screening) 4,100 841 4,941 $2500 Per Pt $3300 Per Pt Total Cost for Infrastructure for Intervention ($2500 to $3300 per patient) * $10,510,000 $13,873,200 Total Cost for Infrastructure for Non-Intervention ($250 to $500 per patient) * $1,235,200 $2,470,400 Total Cost for Infrastructure $11,745,200 $16,343,600 Total Cost for Pediatric Network Group Operations Center & Associated SDMC Applications $33,960,350 $36,088,350 *Accrual from CCOPS should be added for infrastructure costs for interventions and/or non-interventions, if CCOPs accrue to applicable treatment trials led by the Pediatric Network Group and receive “per-case data management funding” from their DCP CCOP grant for treatment trial participation and not from the DCTD Pediatric Network Group Operations Center. Page 214 of 241
PART 4: Appendices Section IV – Cost Components for Budget Preparation for Network Group Ops & SDMC Centers, Lead Academic Sites, & Canadian Trials Network D. Guidelines for Estimating Type 1 Application Total Cost Budget Request for Adult Network Lead Academic Participating Sites FOR PATIENT ENROLLMENT DATA MANAGEMENT COSTS Credit Value for Type 1 Application: $500 $500 $500 $500 $500 "Per Case Management" Funding Category Screening Only (Pts screened on study but did not go on to intervention) Biospecimens Basic Therapeutic Intervention (Including Any Pilot Studies) Advanced Imaging Intervention Page 215 of 241 High- Performance Intervention Credit Multiplier for Category 1 1 4.5 2 8.0 Value of "Per Case Mgt" Funding Category (Credit Value x Credit Multiplier) $500 $500 $2,250 $1,000 $4,000 # of Patients Enrolled at Academic Center/Components 18 85 0 3 85 Total Cost "Per Case Mgt" Funding (# Patients x Value of "Per Case Mgt" Funding) # of Patients Enrolled at Affiliates (Complete Mgt by Academic Center) Total Cost "Per Case Mgt" Funding (# Patients x Value of "Per Case Mgt" Funding) $9,000 $42,500 $0 $3,000 $ 340,000 2 10 10 0 N/A $1,000 $5,000 $22,500 $0 N/A Total Cost to Cover "Per Case Mgt" Funding for All Sites By Category $10,000 $47,500 $22,500 $3,000 $ 340,000 Total Cost for "Per Case Mgt" Funding for All Sites for All Categories $423,000 Total Cost for Scientific Leadership/Coordination at Site 10% Used (Total Cost "Per Case Mgt" Funding for Non-Intervention Studies/Components x 0.10) $5,750 Total Cost for Scientific Leadership/Coordination at Site 20% Used (Total Cost "Per Case Mgt" Funding for Intervention Studies x 0.20) $73,100 Total Cost for Budget Request for Application $501,850 # Patients Enrolled on Network Group Trials - All Intervention Studies 98 # Patients Enrolled on Network Group Trials - High-Performance Intervention Trials 85 # Patients Enrolled on Network Group Trials - Advanced Imaging Intervention Trials 3 # Patients Enrolled on Network Group Trials - Basic Intervention Studies (Including Pilots) 10 # Patients Enrolled on Non-Intervention Studies - Biospecimens & Screening 115 # Patients Enrolled for Screening Only 20 # Patients Enrolled with Biospecimen Collection 95 Accrual Threshold for Academic Center/Components (# Pts) (High-Performance + 50% Advanced Imaging Intervention at Academic Center/Components) 87 Please Note: Figures in red above denote correction to figures in Version 1.0 of the Guidelines Dated 7/23/2012 due to $200 error in initial figures for “Screened Only” patients ($8,800 corrected to $9,000).
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PART 4: Appendices Section IV – Cost Components for Budget Preparation for <strong>Network</strong> Group Ops<br />
& SDMC Centers, Lead Academic Sites, & Canadian <strong>Trials</strong> <strong>Network</strong><br />
D. <strong>Guidelines</strong> for Estimating Type 1 Application Total Cost Budget Request for Adult <strong>Network</strong> Lead<br />
Academic Participating Sites<br />
FOR PATIENT ENROLLMENT DATA MANAGEMENT COSTS<br />
Credit Value for Type 1 Application: $500 $500 $500 $500 $500<br />
"Per Case Management" Funding Category<br />
Screening Only<br />
(Pts screened<br />
on study but<br />
did not go on<br />
to<br />
intervention)<br />
Biospecimens<br />
Basic<br />
Therapeutic<br />
Intervention<br />
(Including Any<br />
Pilot Studies)<br />
Advanced<br />
Imaging<br />
Intervention<br />
Page 215 of 241<br />
High-<br />
Performance<br />
Intervention<br />
Credit Multiplier for Category 1 1 4.5 2 8.0<br />
Value of "Per Case Mgt" Funding Category<br />
(Credit Value x Credit Multiplier)<br />
$500 $500 $2,250 $1,000 $4,000<br />
# of Patients Enrolled at Academic Center/Components 18 85 0 3 85<br />
Total Cost "Per Case Mgt" Funding<br />
(# Patients x Value of "Per Case Mgt" Funding)<br />
# of Patients Enrolled at Affiliates (Complete Mgt by Academic<br />
Center)<br />
Total Cost "Per Case Mgt" Funding<br />
(# Patients x Value of "Per Case Mgt" Funding)<br />
$9,000 $42,500 $0 $3,000 $ 340,000<br />
2 10 10 0 N/A<br />
$1,000 $5,000 $22,500 $0 N/A<br />
Total Cost to Cover "Per Case Mgt" Funding for All Sites By Category $10,000 $47,500 $22,500 $3,000 $ 340,000<br />
Total Cost for "Per Case Mgt" Funding for All Sites for All Categories $423,000<br />
Total Cost for Scientific Leadership/Coordination at Site<br />
10% Used (Total Cost "Per Case Mgt" Funding for Non-Intervention<br />
Studies/Components x 0.10) $5,750<br />
Total Cost for Scientific Leadership/Coordination at Site<br />
20% Used (Total Cost "Per Case Mgt" Funding for Intervention<br />
Studies x 0.20) $73,100<br />
Total Cost for Budget Request for Application $501,850<br />
# Patients Enrolled on <strong>Network</strong> Group <strong>Trials</strong> - All Intervention<br />
Studies 98<br />
# Patients Enrolled on <strong>Network</strong> Group <strong>Trials</strong> - High-Performance<br />
Intervention <strong>Trials</strong> 85<br />
# Patients Enrolled on <strong>Network</strong> Group <strong>Trials</strong> - Advanced Imaging<br />
Intervention <strong>Trials</strong> 3<br />
# Patients Enrolled on <strong>Network</strong> Group <strong>Trials</strong> - Basic Intervention<br />
Studies (Including Pilots) 10<br />
# Patients Enrolled on Non-Intervention Studies - Biospecimens &<br />
Screening 115<br />
# Patients Enrolled for Screening Only 20<br />
# Patients Enrolled with Biospecimen Collection 95<br />
Accrual Threshold for Academic Center/Components (# Pts)<br />
(High-Performance + 50% Advanced Imaging Intervention at<br />
Academic Center/Components) 87<br />
Please Note: Figures in red above denote correction to figures in Version 1.0 of the <strong>Guidelines</strong> Dated 7/23/2012 due to $200 error<br />
in initial figures for “Screened Only” patients ($8,800 corrected to $9,000).