NCI National Clinical Trials Network (NCTN) Program Guidelines

PART 4: Appendices Section II – Required Tables for New/Competing & Non-Competing Applications
II. Suggested Formats - Tables for New & Non-Competing Applications
Current and/or relevant information in the past 5-6 years should be used in the tables unless otherwise indicated. Suggested reporting
period over past 5-6 years for all tables requested for the application, unless otherwise indicated, is January 1, 2007 thru June 30, 2012.
A. Network Group Operations Centers & Canadian Collaborating Network List of Tables with Suggested Formats
Network Group Operations Center applicants should include key leadership, scientific achievements, accrual, and other information (e.g.,
operational efficiency timelines) from participation in the former NCI-sponsored Cooperative Group Clinical Trials Program. Only if the
applicant did not participate in the former NCI-sponsored Cooperative Group Program should the applicant provide accrual and other
information from cancer clinical treatment trials supported by an equivalent non-profit, late-phase (primarily phase 3) clinical trials
network organization that conducts oncology treatment trials (not industry, investigator-initiated, or early phase trials). Accrual tables
are for cancer treatment trials only; if applicant wishes to emphasize significant past accrual on primary advanced imaging studies under
the NCI Cooperative Group Program funded by NCI Division of Cancer Treatment & Diagnosis (DCTD) or equivalent system for applicants
who did not participate in the NCI Cooperative Group Program, that information can be presented in the text of Research Plan under
“Member Site Accrual Program.” Leadership, scientific achievement, and other information from DCTD-sponsored Cooperative Group
primary advanced imaging studies can be included in the appropriate non-accrual tables with achievements from treatment trials.
Canadian Collaborating Clinical Trial Network applicants can also include 1 separate accrual table (modified Table 7) to show treatment
trial accrual for trials they lead for their own organization to highlight their potential for accrual across a range of diseases; however, this
table must be clearly labeled as accrual distinct from the accrual tables on their past participation in NCI Cooperative Group Program.
Table 1. Key Leadership Staffing of Network Group As of Date Application Preparation: MM/DD/YYYY
This table should reflect current positions in the Network Group held by investigators with institutional affiliation as of date this table was
prepared for inclusion in application. Please Note: For key positions by Network Group investigators in NCI Scientific Steering Committees,
task forces & working Groups, NCI CIRBs, etc., that information should be provided in the text of the “Program for Collaboration &
Participation in Collective Management” of Research Plan for Operations Center (see page 111 on research plan & page 160 on review
criteria) & Canadian Collaborating Network applications (see page 148 research plan & page 182 review criteria).
Staffing Category for Network Group
Operations Center
Executive or Oversight Committee
(All members should be listed)
Data and Safety Monitoring Board or
Data Monitoring Committee
(All members should be listed)
Scientific Committee #1
(List Chair and Vice-Chair(s) of the overall
scientific committee only –
Do not include subcommittee heads)
Administrative Committee #1
(List Chair and Vice-Chair(s) of the overall
administrative committee only –
Do not include subcommittee heads)
ETC.
Chair
Member Status Member Name Title Institution
Vice-Chair
Members …….
Chair
Vice-Chair
Members …….
Chair
Vice-Chair
Vice-Chair
Chair
Vice-Chair
Vice-Chair
Length of Service
in Position
Table 2. Important, Primary Scientific Achievements for Trials by Disease Area, Trial Phase, & Trial # from MM/DD/YYYY to
MM/DD/YYYY (Include important, primary scientific achievements that were reported only in the past 5-6 years) - Please Note: The
primary scientific achievement refers to the Primary Endpoint(s) for the trial specified in the protocol document.
Applicants should briefly explain the importance of the achievement regardless of whether the results were positive or
negative as it is the importance of the achievement that is the focus of the table for reviewers, not number of publications.
Cancer
Site
etc.
Trial
Phase
Year
(Publication
or FDA
Indication or
Other)
Trial
Number
& Brief
Title
Experimental
Agent or
Regimen
Primary
Endpoint
Result -
Indication
Manuscript
or Abstract
Reference
Incorporated into
Practice Guidelines
(Type Guidelines,
Year)?
FDA-Approved
Labeling
Indication or
Other Important
Impact
(Describe)?
Date Trial
Activation
Date
Trial
Closed
to
Accrual
Total
Accrual
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