NCI National Clinical Trials Network (NCTN) Program Guidelines

NCI National Clinical Trials Network (NCTN) Program Guidelines NCI National Clinical Trials Network (NCTN) Program Guidelines

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PART 2: Submission of New/Competing Application Section III.B.2.5 – Review Criteria Network RT & Imaging Core Services Centers 2.5 Network Radiotherapy and Imaging Core Services Centers Review Criteria Only the review criteria described below (and the Additional Review Criteria – Overall listed in Part 2 – Section III.B.3.) will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system. 2.5.1 Overall Impact - Overall Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the proposed Network Radiotherapy and Imaging Core Services Centers to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the proposed Network Radiotherapy and Imaging Core Services Centers). 2.5.2 Scored Review Criteria – Overall (Including Program for Collaborations & Participation in Collective Management) Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a proposed Network Radiotherapy and Imaging Core Services Centers that by its nature is not innovative may be essential to advance a field. Significance Does the proposed Network Radiotherapy and Imaging Core Services Centers’ organization help address an important problem or a critical barrier to progress in the field? If the aims of the proposed Network Radiotherapy and Imaging Core Services Centers are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? Investigator(s) Are the PD(s)/PI(s), collaborators, and other researchers well suited to the proposed Network Radiotherapy and Imaging Core Services Centers' plans for support of NCTN trials as well as the Centers' plans for collaborations? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? Given that NCTN Program research projects/trials are collaborative (and irrespective of whether the applicant chooses to use the multi-PD/PI option), do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the support services that the proposed Network Radiotherapy and Imaging Core Services Centers plan to provide? Innovation Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad Page 172 of 241

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? Page 173 of 241

PART 2: Submission of New/Competing Application Section III.B.2.5 – Review Criteria<br />

<strong>Network</strong> RT & Imaging Core Services Centers<br />

2.5 <strong>Network</strong> Radiotherapy and Imaging Core Services Centers Review Criteria<br />

Only the review criteria described below (and the Additional Review Criteria – Overall listed<br />

in Part 2 – Section III.B.3.) will be considered in the review process. As part of the NIH<br />

mission, all applications submitted to the NIH in support of biomedical and behavioral<br />

research are evaluated for scientific and technical merit through the NIH peer review<br />

system.<br />

2.5.1 Overall Impact - Overall<br />

Reviewers will provide an overall impact/priority score to reflect their assessment of<br />

the likelihood for the proposed <strong>Network</strong> Radiotherapy and Imaging Core Services<br />

Centers to exert a sustained, powerful influence on the research field(s) involved, in<br />

consideration of the following review criteria and additional review criteria (as<br />

applicable for the proposed <strong>Network</strong> Radiotherapy and Imaging Core Services<br />

Centers).<br />

2.5.2 Scored Review Criteria – Overall (Including <strong>Program</strong> for Collaborations & Participation<br />

in Collective Management)<br />

Reviewers will consider each of the review criteria below in the determination of<br />

scientific merit, and give a separate score for each. An application does not need to<br />

be strong in all categories to be judged likely to have major scientific impact. For<br />

example, a proposed <strong>Network</strong> Radiotherapy and Imaging Core Services Centers that<br />

by its nature is not innovative may be essential to advance a field.<br />

Significance<br />

Does the proposed <strong>Network</strong> Radiotherapy and Imaging Core Services Centers’<br />

organization help address an important problem or a critical barrier to progress in the<br />

field? If the aims of the proposed <strong>Network</strong> Radiotherapy and Imaging Core Services<br />

Centers are achieved, how will scientific knowledge, technical capability, and/or<br />

clinical practice be improved? How will successful completion of the aims change the<br />

concepts, methods, technologies, treatments, services, or preventative interventions<br />

that drive this field?<br />

Investigator(s)<br />

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the proposed<br />

<strong>Network</strong> Radiotherapy and Imaging Core Services Centers' plans for support of <strong>NCTN</strong><br />

trials as well as the Centers' plans for collaborations? If Early Stage Investigators or<br />

New Investigators, or in the early stages of independent careers, do they have<br />

appropriate experience and training? If established, have they demonstrated an<br />

ongoing record of accomplishments that have advanced their field(s)? Given that<br />

<strong>NCTN</strong> <strong>Program</strong> research projects/trials are collaborative (and irrespective of whether<br />

the applicant chooses to use the multi-PD/PI option), do the investigators have<br />

complementary and integrated expertise; are their leadership approach, governance<br />

and organizational structure appropriate for the support services that the proposed<br />

<strong>Network</strong> Radiotherapy and Imaging Core Services Centers plan to provide?<br />

Innovation<br />

Does the application challenge and seek to shift current research or clinical practice<br />

paradigms by utilizing novel theoretical concepts, approaches or methodologies,<br />

instrumentation, or interventions? Are the concepts, approaches or methodologies,<br />

instrumentation, or interventions novel to one field of research or novel in a broad<br />

Page 172 of 241

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