NCI National Clinical Trials Network (NCTN) Program Guidelines

PART 2: Submission of New/Competing Application Section III.B.2.5 – Review Criteria
Network RT & Imaging Core Services Centers
sense? Is a refinement, improvement, or new application of theoretical concepts,
approaches or methodologies, instrumentation, or interventions proposed?
Approach
Are the overall strategy, methodology, and analyses well-reasoned and appropriate to
accomplish the specific aims of the proposed Network Radiotherapy and Imaging Core
Services Centers? How able do the proposed Network Radiotherapy and Imaging
Core Services Centers appear to be with respect to providing basic interoperability
between the radiotherapy and imaging core service components as well as with other
key components of the NCTN, including electronic exchange of digital planning data
and images and web-based software tools to facilitate trial-specific digital data review
by study chairs for NCTN trials?
Do the proposed Network Radiotherapy and Imaging Core Services Centers have
adequate and appropriate plans for future participation in the development of NEMA
DICOM-RT standards (http://medical.nema.org/ ) and in the support of trials which
merge imaging from different platforms such as FDG PET, CT, MRI, and other
platforms? Are potential problems, alternative strategies, and benchmarks for
success presented? If the project is in the early stages of development, will the
strategy establish feasibility and will particularly risky aspects be managed?
Since the proposed Network Radiotherapy and Imaging Core Services Centers will
help support clinical research, are the plans for 1) protection of human subjects from
research risks, and 2) inclusion of minorities and members of both sexes/genders, as
well as the inclusion of children, justified in terms of the scientific goals and research
strategy proposed?
Do the proposed Network Radiotherapy and Imaging Core Services Centers have
procedures in place to verify that they can comply with all applicable
federal/DHHS/NIH/NCI policies and regulations regarding the use of data from clinical
trials involving human subjects, including data security and protected medical
information safeguards?
Environment
Will the scientific environment in which the work will be done contribute to the
probability of success? Are the institutional support, equipment and other physical
resources available to the investigators adequate for the project proposed? Will the
support services that the proposed Network Radiotherapy and Imaging Core Services
Centers plan to provide benefit from unique features of the scientific environment,
subject populations, or collaborative arrangements?
Does the applicant adequately demonstrate the capacity for interoperability with the
common data management system (CDMS) of the NCTN Program to collect clinical
trial data and link information to clinical data collected by other key components of
the NCTN Program such as Network Group Operations Centers and associated
Network Group Statistics and Data Management Centers? How well does it appear
that the proposed Network Radiotherapy and Imaging Core Services Centers will be
able to work with the NCTN Program tools and services employed for regulatory
support and patient enrollment (i.e., the Regulatory Support System (RSS) and the
Oncology Patient Enrollment Network (OPEN) for all NCTN clinical trials?
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