NCI National Clinical Trials Network (NCTN) Program Guidelines

PART 2: Submission of New/Competing Application Section II – Budget/Research Plan
Network Group Ops Center
Research Directions. Define the overall research directions for the development of clinical
trials in specific disease areas and patient populations over a broad range of cancer types. In
particular, the applicant team must identify the diseases that the proposed Operations
Center will pursue in its research and outline how its particular research objectives will
benefit the NCTN Program as a whole. The applicant team should also address how its
research strategy will address unmet clinical needs in rare cancers.
Capabilities and Experience. Summarize the capabilities and experience of the applicant
team in successfully developing, organizing, and coordinating large-scale, definitive clinical
trials as well as experience in leveraging resources from multiple funding sources for the
conduct of ancillary studies (e.g., correlative science studies) associated with clinical trials.
Outline the most important achievements in these areas over the past 5-6 years.
Promising Directions. Identify the most promising current and future research initiatives
and clinical trials as an indication of the potential of the applicant team to contribute to the
NCTN Program. It is expected that applicants' emphasis will be placed on studies with
potential to change clinical practice and the importance of the overall research strategy
being pursued and not on individual disease clinical trial portfolios.
Role of Senior Members of Research Teams. Include information on the current
participation of senior members of applicant’s research teams in relevant committees (e.g.,
scientific research committees and administrative committees). Outline the current
situation and plans for the involvement of senior members in the mentoring of new/junior
investigators in clinical trial research.
NOTE: Information on the applicant’s scientific leadership in clinical trial development as
well as achievements of its past (over the prior 5 to 6 years) and current clinical trial
development program may be summarized in tables. Use of template Tables #1, #2, #3, and
#4 as described in Part 4 - Appendices – Section II.A. of these Guidelines for the NCTN
Program is highly recommended and may be included in the Resources section of the
application.
2.3 Sub-Section C. Member Site Accrual Program (up to 12 pages)
This functional component is critical for the role of the Operations Center. Include in this
sub-section a well-defined plan for robust accrual of patients to NCTN clinical trials. In this
plan, describe how the Operations Center will work with the member institutions/sites of
clinical trials that are or will be affiliated with the applicants. This plan must encompass
accrual to clinical trials led by the applicant as well as trials that may be led by other Network
Groups. Emphasis should be placed on overall accrual to the NCTN not on accrual specific
to trials led by the Network Group Operations Center. Summarize the potential of the
proposed Operations Center to accrue (via its member institutions/sites) patients to
oncology clinical treatment trials and advanced imaging trials in a publicly funded clinical
trials system across a broad range of diseases, including rare cancers.
NOTE: In this sub-section, the applicants are expected to highlight the track record of the
applicant team and its member sites for accrual over the past 5-6 years with accrual
summarized in tables. Use of template Tables #5, #6, and #7 as described in Part 4 -
Appendices – Section II.A. of these Guidelines for the NCTN Program is highly
recommended and may be included in the Resources section of the application.
2.4 Sub-Section D. Operational Management (up to 12 pages)
In this sub-section, address the organizational structure of the proposed Operations Center,
its governance, standard operating procedures, and operational efficiency program. All
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