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

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

ctep.cancer.gov
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12.01.2013 Views

PART 2: Submission of New/Competing Application Section III.B.2.3 – Review Criteria Integrated Translational Science Center Approach Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the proposed Network Group Integrated Translational Science Center? 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 Group Integrated Translational Science Center 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, if applicable as not all applications will involve translational studies for clinical trials involving children) justified in terms of the scientific goals and research strategy proposed? 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 translational research studies and pilot studies designed and performed by the Network Group Integrated Translational Science Center benefit from unique features of the scientific environment, subject populations, or collaborative arrangements? Additional Review Criteria As applicable for the research that the Network Group Integrated Translational Science Center has proposed, reviewers will evaluate the following additional items A-B while determining scientific and technical merit, and in providing an overall impact/priority score, but will not give separate scores for these items. 2.3.3 Additional Review Item A – Integrated Translational Science Program A. Integrated Translational Science Program How complete and comprehensive are the expertise of the PD(s)/PI(s) and the entire team of investigators assembled by the applicant in terms of their ability to provide scientific and technical expertise for state-of-the-art translational science for early and late phase clinical trials in adults and/or adolescents and young adults and children with cancer? Have the PD(s)/PI(s) had a successful track record of developing integral and integrated translational science studies, including molecular and/or imaging biomarker assessment, for large-scale, multiinstitutional clinical trials conducted by a non-profit clinical trials network? Do the experience and qualifications of the PD(s)/PI(s) provide complementary scientific, technical, and administrative expertise for the research team? Will the investigators involved be able to work as a coherent research team with the Network Group Operations Center(s) and Network Group Statistics and Data Management Center(s) supporting the application to provide these services efficiently and expeditiously for NCTN clinical trials? Does the application describe a clear governance structure for how the investigators and their institutions will interact and coordinate activities with the supporting Network Group components? In particular, how will activities be coordinated across various disciplines and departments at different institutions? Are the time and effort that the PD(s)/PI(s) are devoting to the Center appropriate and sufficient to Page 166 of 241

PART 2: Submission of New/Competing Application Section III.B.2.3 – Review Criteria Integrated Translational Science Center achieve the goals of the application? Does the application clearly show substantial commitment of the institution(s) and investigators in terms of leveraging institutional and investigator resources, especially laboratory resources, to enhance development of translational science studies as well as pilot studies, including validation of assay performance? If the application includes multiple PD(s)/PI(s), are the proposed leadership governance, organizational structure, and decision-making processes and interactions among the members of the leadership team for the application optimal for achieving the goals of the application? Does the application describe a well-defined plan for how the PD(s)/PI(s) will actively participate in the scientific meetings of the Group Operations Center(s) and Network Group Statistics and Data Management Center(s) supporting the application as well as other activities of the NCTN Program (e.g., NCI diseasespecific Steering Committees and associated task forces and working groups, Clinical Trials Planning Committees for meetings, and other NIH/NCI initiatives related to translational science research)? Do the applicants 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? 2.3.4 Additional Review Item B – Pilot Studies and Collaborative Projects B. Pilot Studies and Collaborative Projects Does the research plan adequately address the how pilot studies will be selected and how they will be performed to enable acquisition of preliminary data for further research that will be conducted related to the overall translational science research strategy? Is the relationship between these pilot studies and the overall research strategy clearly explained and appropriate for the overall goals of the application? Do the applicants have the appropriate facilities and expertise to perform the non-clinical aspects of any pilot studies proposed (e.g., molecular biomarker assays)? Can the investigators leverage independently funded laboratory resources with clinical data and biospecimens from the clinical trials conducted by the supporting Group Operations Center(s) and Network Group Statistics and Data Management Center(s) to benefit the research aims of the application? Are there an adequate plan and potential for collaborating with other NIH/NCI programs and organizations (e.g., SPOREs, NCI Cancer Centers, etc.) to facilitate hand-offs of results from early phase clinical trials and/or translational science research discoveries? Page 167 of 241

PART 2: Submission of New/Competing Application Section III.B.2.3 – Review Criteria<br />

Integrated Translational Science Center<br />

achieve the goals of the application? Does the application clearly show<br />

substantial commitment of the institution(s) and investigators in terms of<br />

leveraging institutional and investigator resources, especially laboratory<br />

resources, to enhance development of translational science studies as well as<br />

pilot studies, including validation of assay performance?<br />

If the application includes multiple PD(s)/PI(s), are the proposed leadership<br />

governance, organizational structure, and decision-making processes and<br />

interactions among the members of the leadership team for the application<br />

optimal for achieving the goals of the application?<br />

Does the application describe a well-defined plan for how the PD(s)/PI(s) will<br />

actively participate in the scientific meetings of the Group Operations Center(s)<br />

and <strong>Network</strong> Group Statistics and Data Management Center(s) supporting the<br />

application as well as other activities of the <strong>NCTN</strong> <strong>Program</strong> (e.g., <strong>NCI</strong> diseasespecific<br />

Steering Committees and associated task forces and working groups,<br />

<strong>Clinical</strong> <strong>Trials</strong> Planning Committees for meetings, and other NIH/<strong>NCI</strong> initiatives<br />

related to translational science research)?<br />

Do the applicants have procedures in place to verify that they can comply with all<br />

applicable federal/DHHS/NIH/<strong>NCI</strong> policies and regulations regarding the use of<br />

data from clinical trials involving human subjects, including data security and<br />

protected medical information safeguards?<br />

2.3.4 Additional Review Item B – Pilot Studies and Collaborative Projects<br />

B. Pilot Studies and Collaborative Projects<br />

Does the research plan adequately address the how pilot studies will be selected<br />

and how they will be performed to enable acquisition of preliminary data for<br />

further research that will be conducted related to the overall translational science<br />

research strategy? Is the relationship between these pilot studies and the overall<br />

research strategy clearly explained and appropriate for the overall goals of the<br />

application?<br />

Do the applicants have the appropriate facilities and expertise to perform the<br />

non-clinical aspects of any pilot studies proposed (e.g., molecular biomarker<br />

assays)? Can the investigators leverage independently funded laboratory<br />

resources with clinical data and biospecimens from the clinical trials conducted<br />

by the supporting Group Operations Center(s) and <strong>Network</strong> Group Statistics and<br />

Data Management Center(s) to benefit the research aims of the application?<br />

Are there an adequate plan and potential for collaborating with other NIH/<strong>NCI</strong><br />

programs and organizations (e.g., SPOREs, <strong>NCI</strong> Cancer Centers, etc.) to facilitate<br />

hand-offs of results from early phase clinical trials and/or translational science<br />

research discoveries?<br />

Page 167 of 241

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