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 2: Submission of New/Competing Application Section III.B.2.5 – Review Criteria Network RT & Imaging Core Services Centers Do the proposed Network Radiotherapy and Imaging Core Services Centers have a track record for collaborations with other clinical trial organizations and/or other NCIsponsored programs and investigators (e.g., SPOREs, NCI Cancer Centers, R01/P01 investigators), especially with respect to development of standards and harmonization of processes and data collection that indicates the Centers have the potential to be provide additional benefits to the NCTN Program? Do the proposed Network Radiotherapy and Imaging Core Services Centers demonstrate the potential to enhance services and provide best practices and/or standards for selected assessments of radiotherapy and advanced imaging techniques? Do the proposed Network Radiotherapy and Imaging Core Services Centers have a track record that demonstrates that the members of its senior leadership team and staff can actively participate in and contribute productively to NCI and NCTN clinical trial activities (e.g., disease-specific and modality-specific Scientific Steering Committees and related task forces or working Groups, Clinical Trials Planning Committees for meetings supported by the NCI disease-specific Steering Committees, participation in other NCI programs and initiatives related to clinical research)? Does the applicant demonstrate the capacity to implement new initiatives and standards in a timely fashion? Do the proposed Network Radiotherapy and Imaging Core Services Centers provide adequate real-time user support in the form of a “Help Desk” which can also collect feedback for continual improvement of functionality of the core services? Additional Scored Review Criteria In addition to the above review criteria, the following additional criteria A-B will be applied to applications in the determination of scientific merit and the impact/priority score. Reviewers will consider each of the additional review criteria below in the determination of scientific merit, and give a separate score for each. A. Radiotherapy Core Services Center Program B. Imaging Core Services Center Program 2.5.3 Scored Review Criteria – Criterion A. Radiotherapy Core Services Center Program (Note: The entire Criterion A will receive one individual score; the subcategories and aspects listed will be assessed but not scored separately). Does the plan for providing support services for radiotherapy in clinical trials adequately address the key functional needs for a Radiotherapy Core Services Center, including collection, distribution, analysis, and storage/archiving of all primary and adjunct radiotherapy treatment delivery data for applicable NCTN trials? Does the plan for providing support services for radiotherapy in clinical trials include an adequate approach, with appropriate policies and procedures, for how information and services will be coordinated with the Imaging Core Services Center? Does the proposed Radiotherapy Core Services Center provide continued maintenance of robust physical hardware and information technology (IT) networks which ensure the operational integrity and security of the core services? How well does it appear the proposed Radiotherapy Core Services Center could incorporate data from legacy trials of potential Network Group Operations Centers and their associated Network Group Statistics and Data Management Centers (SDMCs)? Page 174 of 241
PART 2: Submission of New/Competing Application Section III.B.2.5 – Review Criteria Network RT & Imaging Core Services Centers Do implementation plans for the functional services provided by the Radiotherapy Core Services Center appear that they are or will be implemented efficiently and in a cost-effective manner? Do the standard operating procedures (SOPs) as well as tool generation and evaluation by the proposed Radiotherapy Core Services Center appear to be effective and efficient? How well would the proposed Radiotherapy Core Services Center be able to provide core services support for NCTN collaborative trials with other NCI-sponsored investigators and programs (e.g., NCI/DCTD early phase clinical trials programs)? Does the proposed Radiotherapy Core Services Center have the appropriate infrastructure to provide appropriate uniform quality assurance (QA) procedures and review for advanced radiotherapy trials, including dosimetry, that are developed by the NCTN, including digital data capture, rapid analysis of volumetric treatment planning data, and physical dose assurance capabilities? Does the proposed Radiotherapy Core Services Center have the infrastructure and ability to provide appropriate quality assurance support for the following elements associated with multi-institutional clinical trials: radiation dose delivery by photons, electron and protons for external beam radiotherapy and brachytherapy, use of anthropomorphic phantoms for complex treatment delivery, archiving and remote review of digital data including 3D and 4D images and RT objects? Does the proposed Radiotherapy Core Services Center have the ability to provide uniform credentialing of institutions that might participate in applicable NCTN trials including those which use advanced radiotherapy treatment and assist Network Group Operations Centers and their associated SDMCs in the development of applicable trials with advanced radiotherapy, especially related to the need for specialized quality assurance, target volume definitions, and data submission requirements? 2.5.4 Scored Review Criteria – Criterion B. Imaging Core Services Center Program (Note: The entire Criterion B will receive one individual score; the subcategories and aspects listed will be assessed but not scored separately). Does the plan for providing support services for imaging in clinical trials adequately address the key functional needs for an Imaging Core Services Center, including collection, distribution, analysis, and storage/archiving of all primary and adjunct imaging delivery data for applicable NCTN trials? Does the plan for providing support services for imaging in clinical trials include an adequate approach, with appropriate policies and procedures, for how information and services will be coordinated with the Radiotherapy Core Services Center? Does the proposed Imaging Core Services Center provide continued maintenance of robust physical hardware and information technology (IT) networks which ensure the operational integrity and security of the core services? How well does it appear the proposed Imaging Core Services Center could incorporate data from legacy trials of potential Network Group Operations Centers and their associated Network Group Statistics and Data Management Centers (SDMCs)? Page 175 of 241
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PART 2: Submission of New/Competing Application Section III.B.2.5 – Review Criteria<br />
<strong>Network</strong> RT & Imaging Core Services Centers<br />
Do the proposed <strong>Network</strong> Radiotherapy and Imaging Core Services Centers have a<br />
track record for collaborations with other clinical trial organizations and/or other <strong>NCI</strong>sponsored<br />
programs and investigators (e.g., SPOREs, <strong>NCI</strong> Cancer Centers, R01/P01<br />
investigators), especially with respect to development of standards and<br />
harmonization of processes and data collection that indicates the Centers have the<br />
potential to be provide additional benefits to the <strong>NCTN</strong> <strong>Program</strong>? Do the proposed<br />
<strong>Network</strong> Radiotherapy and Imaging Core Services Centers demonstrate the potential<br />
to enhance services and provide best practices and/or standards for selected<br />
assessments of radiotherapy and advanced imaging techniques?<br />
Do the proposed <strong>Network</strong> Radiotherapy and Imaging Core Services Centers have a<br />
track record that demonstrates that the members of its senior leadership team and<br />
staff can actively participate in and contribute productively to <strong>NCI</strong> and <strong>NCTN</strong> clinical<br />
trial activities (e.g., disease-specific and modality-specific Scientific Steering<br />
Committees and related task forces or working Groups, <strong>Clinical</strong> <strong>Trials</strong> Planning<br />
Committees for meetings supported by the <strong>NCI</strong> disease-specific Steering Committees,<br />
participation in other <strong>NCI</strong> programs and initiatives related to clinical research)? Does<br />
the applicant demonstrate the capacity to implement new initiatives and standards in<br />
a timely fashion?<br />
Do the proposed <strong>Network</strong> Radiotherapy and Imaging Core Services Centers provide<br />
adequate real-time user support in the form of a “Help Desk” which can also collect<br />
feedback for continual improvement of functionality of the core services?<br />
Additional Scored Review Criteria<br />
In addition to the above review criteria, the following additional criteria A-B will be<br />
applied to applications in the determination of scientific merit and the impact/priority<br />
score. Reviewers will consider each of the additional review criteria below in the<br />
determination of scientific merit, and give a separate score for each.<br />
A. Radiotherapy Core Services Center <strong>Program</strong><br />
B. Imaging Core Services Center <strong>Program</strong><br />
2.5.3 Scored Review Criteria – Criterion A. Radiotherapy Core Services Center <strong>Program</strong><br />
(Note: The entire Criterion A will receive one individual score; the subcategories and<br />
aspects listed will be assessed but not scored separately).<br />
Does the plan for providing support services for radiotherapy in clinical trials<br />
adequately address the key functional needs for a Radiotherapy Core Services Center,<br />
including collection, distribution, analysis, and storage/archiving of all primary and<br />
adjunct radiotherapy treatment delivery data for applicable <strong>NCTN</strong> trials?<br />
Does the plan for providing support services for radiotherapy in clinical trials include<br />
an adequate approach, with appropriate policies and procedures, for how information<br />
and services will be coordinated with the Imaging Core Services Center?<br />
Does the proposed Radiotherapy Core Services Center provide continued<br />
maintenance of robust physical hardware and information technology (IT) networks<br />
which ensure the operational integrity and security of the core services? How well<br />
does it appear the proposed Radiotherapy Core Services Center could incorporate<br />
data from legacy trials of potential <strong>Network</strong> Group Operations Centers and their<br />
associated <strong>Network</strong> Group Statistics and Data Management Centers (SDMCs)?<br />
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