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 implementation plans for the functional services provided by the proposed Imaging 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 Imaging Core Services Center appear to be effective and efficient? Does the proposed Imaging Core Services Center have the capacity to provide appropriate core services support for NCTN collaborative trials with other NCIsponsored investigators and programs (e.g., NCI/DCTD early phase clinical trials programs)? How well does it appear the proposed Imaging Core Services Center would provide quality assurance for imaging-related activities in applicable NCTN trials, including site and scanner qualification/calibration, review of imaging data for acceptability and protocol compliance, and central analysis and evaluation of images? Does the proposed Imaging Core Services Center provide appropriate standardized and harmonized imaging processes and procedures that could be used by investigators participating in applicable NCTN trials using the Center’s core services? How well would the proposed Imaging Core Services Center be able to provide assistance with development of trials that have imaging as either a research objective or use imaging in support of other research goals for applicable NCTN trials? How well does it appear that the proposed Imaging Core Services Center would be able to evaluate and assimilate evolving imaging technologies into future trials as well as to incorporate new commercial tools used for image processing and analysis as they become available? How well would the proposed Imaging Core Services Center be able to develop and maintain processes and procedures to conduct remote central imaging reads with the required scientific expertise? Would the proposed Imaging Core Services Center be able to provide appropriate procedures by which the priority and needs of imaging support could be adjusted for specific trials, including providing both “real-time” and “post-review” of images and providing expertise as to the best approach for a particular trial? Does the proposed Imaging Core Services Center have an appropriate plan to incorporate a technical capacity to segregate access-limited collection for ongoing clinical trials from open-access collection when they are conducted by the NCTN? Page 176 of 241
PART 2: Submission of New/Competing Application Section III.B.2.6 – Review Criteria Canadian Collaborating Clinical Trials Network 2.6 Canadian Collaborating Clinical Trials Network 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. 2.6.1 Overall Impact - Overall Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the proposed Canadian Collaborating Clinical Trials Network 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 Canadian Collaborating Clinical Trials Network). 2.6.2 Scored Review Criteria – Overall 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 Clinical Trials Network that by its nature may not be innovative but it may be essential to advance a field. Significance Does the proposed Canadian Collaborating Clinical Trials Network address an important problem or a critical barrier to progress in the field? If the aims of the proposed Canadian Collaborating Clinical Trials Network 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 Canadian Collaborating Clinical Trials Network? 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 the NCTN Program research projects/trials are collaborative and the proposed Canadian Collaborating Clinical Trials Network will be involved in collaborative activities (and irrespective of whether the applicants choose 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 clinical research conducted by the proposed Canadian Collaborating Clinical Trials Network? 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 sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed? Page 177 of 241
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PART 2: Submission of New/Competing Application Section III.B.2.6 – Review Criteria<br />
Canadian Collaborating <strong>Clinical</strong> <strong>Trials</strong> <strong>Network</strong><br />
2.6 Canadian Collaborating <strong>Clinical</strong> <strong>Trials</strong> <strong>Network</strong> 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 />
2.6.1 Overall Impact - Overall<br />
Reviewers will provide an overall impact/priority score to reflect their assessment of<br />
the likelihood for the proposed Canadian Collaborating <strong>Clinical</strong> <strong>Trials</strong> <strong>Network</strong> to exert<br />
a sustained, powerful influence on the research field(s) involved, in consideration of<br />
the following review criteria and additional review criteria (as applicable for the<br />
proposed Canadian Collaborating <strong>Clinical</strong> <strong>Trials</strong> <strong>Network</strong>).<br />
2.6.2 Scored Review Criteria – Overall<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>Clinical</strong> <strong>Trials</strong> <strong>Network</strong> that by its nature may not be innovative<br />
but it may be essential to advance a field.<br />
Significance<br />
Does the proposed Canadian Collaborating <strong>Clinical</strong> <strong>Trials</strong> <strong>Network</strong> address an<br />
important problem or a critical barrier to progress in the field? If the aims of the<br />
proposed Canadian Collaborating <strong>Clinical</strong> <strong>Trials</strong> <strong>Network</strong> are achieved, how will<br />
scientific knowledge, technical capability, and/or clinical practice be improved? How<br />
will successful completion of the aims change the concepts, methods, technologies,<br />
treatments, services, or preventative interventions that drive this field?<br />
Investigator(s)<br />
Are the PD(s)/PI(s), collaborators, and other researchers well suited to the proposed<br />
Canadian Collaborating <strong>Clinical</strong> <strong>Trials</strong> <strong>Network</strong>? If Early Stage Investigators or New<br />
Investigators, or in the early stages of independent careers, do they have appropriate<br />
experience and training? If established, have they demonstrated an ongoing record of<br />
accomplishments that have advanced their field(s)? Given that the <strong>NCTN</strong> <strong>Program</strong><br />
research projects/trials are collaborative and the proposed Canadian Collaborating<br />
<strong>Clinical</strong> <strong>Trials</strong> <strong>Network</strong> will be involved in collaborative activities (and irrespective of<br />
whether the applicants choose to use the multi-PD/PI option), do the investigators<br />
have complementary and integrated expertise; are their leadership approach,<br />
governance and organizational structure appropriate for the clinical research<br />
conducted by the proposed Canadian Collaborating <strong>Clinical</strong> <strong>Trials</strong> <strong>Network</strong>?<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 />
sense? Is a refinement, improvement, or new application of theoretical concepts,<br />
approaches or methodologies, instrumentation, or interventions proposed?<br />
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