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 III – Schema for Review/Evaluation of NCTN Study Proposals III. Schema of NCI/DCTD Study Proposal Review/Evaluation NCI/DCTD Review/Evaluation Process for NCTN Study Proposals PILOT and PHASE 1 Letter of Intent (LOI) Review by NCI/DCTD PRC Yes Intervention Trials (Treatment and Advanced Imaging) PHASE 1/2 and PHASE 2 Response to CTEP Mass or Specific Solicitation? No Total Sample Size < 100 Letter of Intent (LOI) Review by NCI/DCTD PRC CTEP may refer therapeutic trials with total sample sizes ≥ 90 < 100 to NCI SSCs No Total Sample Size ≥ 100 (or any pediatric phase 2 or pediatric pilot study ≥ 100) PHASE 2/3 and PHASE 3 Concept Evaluation by NCI Scientific Steering Committee (SSC) If no NCI SSC in disease, then NCI/DCTD PRC review (w/ ad hoc extramural reviewers) OR If study is in response to an NCI/DCTD specific solicitation, then NCI/DCTD PRC review Non-Intervention Study (i.e., Correlative Science Study with request for banked biospecimens from an NCTN trial) Study Proposal Review by NCI/DCTD PRC or NCI/DCTD-Approved Correlative Science Committee Review with comments by NCI/DCTD company collaborator per IP Option may be necessary Page 210 of 241 Review of study proposals may be expedited depending on # and type of specimens requested and clinical data requested
PART 4: Appendices Section IV – Cost Components for Budget Preparation for Network Group Ops & SDMC Centers, Lead Academic Sites, & Canadian Trials Network IV. Cost Components for Budget Preparation for Network Group Operations Centers and SDMCs, Network Lead Academic Participating Sites, and Canadian Collaboration Clinical Trials Network New Applications A. Guidelines for General Budget Inputs for Estimating Total Cost Budget Requests – Type 1 Application TOTAL COST Credit Value for Type 1 Applications: $500 "Per Case Management" Funding Category Credit Multiplier Total Cost Value (Total Cost Credit Value of $500 x Credit Multiplier) Intervention or Non-Intervention Category High Performance Intervention - Therapeutic 8 $4,000 Intervention Basic Intervention (Including Therapeutic Pilot Studies) – Therapeutic 4.5 $2,250 Intervention Basic Intervention - Advanced Imaging 2 $1,000 Intervention Screening 1 $500 Non-Intervention Biospecimen 1 $500 Determined on trial-specific basis Non-Intervention Special N/A by NCI/DCTD N/A Total Cost for Financial Management Oversight Based on % of Total Cost of "Per Case Management" Funding for Intervention and Non-Intervention Categories (Suggested Range for %) * Intervention Per Case Category Non-Intervention Per Case Category Adult Network Groups 10% to 20% 5% to 10% Pediatric Network Groups 10% to 20% 5% to 10% Total Cost for Operations Center and SDMC Infrastructure Based on $ Multiplier for Accrual to Network Group Trials Per Patient Enrolled for Intervention and Non-Intervention Categories (Suggested Range for $ Multiplier) Intervention Accrual Category (Per Enrolled Patient) Non-Intervention Accrual Category (Per Enrolled Patient) Operations & SDMCs for Network Groups & Canadian Network $2,500 to $3,300 $250 to $500 Total Cost for Scientific Leadership/Coordination at Lead Academic Participating Sites & Pediatric High-Performance Sites Based on % of Total Cost for "Per Case Mgt" Funding for Intervention and Non-Intervention Categories (Suggested Range for %) Intervention Per Case Category Non- Intervention Per Case Category Network Lead Academic Participating Sites 10% to 20% 5% to 10% Pediatric Network Groups 10% to 20% 5% to 10% Suggested Range for Pediatric Threshold for "High-Performance Intervention Per Case Mgt" Funding as % of Total Intervention Accrual (Therapeutic Enrollments + 50% Advanced Imaging Enrollments) Range Pediatric Network Group 55% to 75% *Please Note: A Financial Management Oversight Cost % is NOT part of the algorithm to determine the ballpark total cost budget figure for the Lead Academic Participating Site budget since the NCI provides funding to cover costs directly to the Lead Academic Participating Site via its award. Page 211 of 241
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PART 4: Appendices Section III – Schema for Review/Evaluation of <strong>NCTN</strong> Study Proposals<br />
III. Schema of <strong>NCI</strong>/DCTD Study Proposal Review/Evaluation<br />
<strong>NCI</strong>/DCTD Review/Evaluation Process for <strong>NCTN</strong> Study Proposals<br />
PILOT<br />
and<br />
PHASE 1<br />
Letter of Intent<br />
(LOI)<br />
Review by<br />
<strong>NCI</strong>/DCTD PRC<br />
Yes<br />
Intervention <strong>Trials</strong><br />
(Treatment and Advanced Imaging)<br />
PHASE 1/2<br />
and<br />
PHASE 2<br />
Response to<br />
CTEP<br />
Mass or Specific<br />
Solicitation?<br />
No<br />
Total Sample<br />
Size < 100<br />
Letter of Intent (LOI)<br />
Review by<br />
<strong>NCI</strong>/DCTD PRC<br />
CTEP may refer<br />
therapeutic trials with<br />
total sample sizes<br />
≥ 90 < 100 to<br />
<strong>NCI</strong> SSCs<br />
No<br />
Total Sample Size ≥ 100<br />
(or any pediatric<br />
phase 2 or pediatric<br />
pilot study ≥ 100)<br />
PHASE 2/3<br />
and<br />
PHASE 3<br />
Concept Evaluation<br />
by <strong>NCI</strong> Scientific<br />
Steering Committee<br />
(SSC)<br />
If no <strong>NCI</strong> SSC in disease,<br />
then <strong>NCI</strong>/DCTD PRC review<br />
(w/ ad hoc extramural reviewers)<br />
OR<br />
If study is in response to an<br />
<strong>NCI</strong>/DCTD specific solicitation,<br />
then <strong>NCI</strong>/DCTD PRC review<br />
Non-Intervention Study<br />
(i.e., Correlative Science Study<br />
with request for banked<br />
biospecimens from an<br />
<strong>NCTN</strong> trial)<br />
Study Proposal Review by<br />
<strong>NCI</strong>/DCTD PRC or<br />
<strong>NCI</strong>/DCTD-Approved<br />
Correlative Science<br />
Committee<br />
Review with comments by<br />
<strong>NCI</strong>/DCTD company<br />
collaborator per IP Option may<br />
be necessary<br />
Page 210 of 241<br />
Review of<br />
study<br />
proposals<br />
may be<br />
expedited<br />
depending<br />
on<br />
# and type<br />
of<br />
specimens<br />
requested<br />
and clinical<br />
data<br />
requested
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