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Clinical Trials Cooperative Group Program Guidelines, August 1996VIII. Peer Review Upon receipt, applications will be reviewed for completeness by DRG and for responsiveness by the NCI. Incomplete and nonresponsive applications will be returned to the applicant without further consideration. Applications that are complete and responsive to these Guidelines will be evaluated for scientific and technical merit by the Clinical Groups Subcommittee (formerly the Cancer Clinical Investigations Review Committee or CCIRC) of the National Cancer Institute in accordance with the review criteria stated below. This chartered peer review subcommittee is multidisciplinary and encompasses all oncologic specialties, cancer control, statistics, and cooperative group administration. The full subcommittee review is usually preceded by a site visit to the Group's statistical and data management facilities. The site visit team generally consists of subcommittee members plus ad hoc reviewers as indicated by the proposed research plan. The Scientific Review Administrator of the subcommittee is responsible for all aspects of the peer review process, and will negotiate with the Group chairperson the date, duration and content of the site visit. The Scientific Review Administrator will request from Headquarters, for use at the site visit, complete patient accrual records for each institution as well as performance evaluations based on committee membership, data quality and other Group standards; these may be supplied in the form of tables. The findings of the site visit team are provided to the subcommittee during its consideration of the application at its regular meeting. The initial peer review process provides the NCI with a critical assessment of the Group's research capabilities and plans. It also provides important feedback on the functioning of the cooperative agreement relationship between CTEP and the Group. The major emphasis of the review is on the quality of the future research plans projected for the subsequent period of support requested in the application. The recommendations and priority score(s) voted by the subcommittee are presented to the National Cancer Advisory Board (NCAB) for second level review and recommendation to the NCI. Final funding decisions are then made by the NCI for those applications recommended for approval by the NCAB. VIII.1 GENERAL CONSIDERATIONS OF
COOPERATIVE GROUP REVIEW Because of their interrelatedness, all applications from all
components of a particular Cooperative Group are reviewed
simultaneously (except in the case of member applications
submitted out-of sequence with the parent Group, section
VII.1.D., or competing supplement applications, section
VII.I.C.). Using the operational model of Part VI, the content of
the Headquarters application is first evaluated; this review is
an integral part of the review of each individual application of
the Group, regardless of component. The review group then votes
either to (i) recommend the application for scoring or (ii) not
recommend it for further consideration. If the application is
recommended for scoring, the subcommittee assigns a priority
score representing the overall peer review evaluation of the
Group and recommends a period of award (generally three to five
years). If the Headquarters application is scored, the review
group then evaluates the applications of other individual
components. The review group also develops budgetary
recommendations for each scored application concerning the effort
and resources needed to perform the approved research. If the
Headquarters application is not recommended for further
consideration, the applications of the individual components are
not reviewed and the Group's applications cannot be funded. VIII.1.A Scientific Committee Review A review of the Group's scientific committees and plans is the
first stage of the Group site visit. Its major focus is the
research of the Group as reflected in its protocols and working
plans. For each area of Group study, all currently active
protocols and all correspondence between CTEP and the Group
related to each protocol, including the PRC's consensus reviews,
are provided to the committee. With this background the team then
makes an assessment of the Group's research approach and plans
for each area. VIII.1.B. Group Management, Study Conduct, and Membership The focus of the site visit then broadens to the whole Group.
This includes the Group's science as reflected in its research
priorities and clinical trials practices, all aspects of its
management and administration (including monitoring of data
quality, both centrally and on-site, and adherence to regulatory
requirements) as an organizational unit developing and conducting
clinical trials, the cohesiveness of its components, and the
quality of its primary members. Time is provided for the Group
Chairperson to meet with the site visitors in an executive
session; some of this time is devoted to a discussion of
individual member institution contributions. VIII.1.C. Parent Committee Reviews Initial peer review is completed by the Clinical Groups
Subcommittee of the National Cancer Institute Initial Review
Group. This body reviews the application(s) submitted by the
Group as well as the site visit report. The subcommittee brings a
broad and consistent perspective to the review of the Clinical
Trials Cooperative Group Program; priority scores for each scored
application are assigned by the subcommittee. The review criteria employed by the site visit team and the
Clinical Groups Subcommittee for each of the three operational
components are summarized in the following three sections. 1. Merit of Specific Research Plans - How meritorious are the research plans and strategies for each of the major areas of study? Are they appropriate in the context of national priorities? Are guidelines for the inclusion of women and minorities as research subjects being followed? 2. Research Methodology - How well designed are the Group's planned clinical trials? Will their design allow clinically important conclusions to be drawn? 3. Publication Record - Is the Group's research published in a timely manner and in quality peer-reviewed journals? 4. Translational Research Is there a well defined plan to integrate correlative studies into the overall research effort? While not required, the capacity and expertise within the Group to develop innovative research ideas based on laboratory models and pilot these in limited institution trials with an eye to their potential use as experimental arms in phase III trials is a strength. 5. Key Personnel - Does the research experience and qualifications of the Principal Investigator demonstrate understanding of design, administration, and analysis of multi-institutional clinical trials in cancer treatment and relevant laboratory studies? 6. Patient Accrual - Is the membership of the Group adequate to mount multiple, concurrent, large-scale clinical trials? 7. Efficiency of Study Development - Does the process of study development proceed in an efficient and timely manner? Are important studies rapidly developed and implemented? 8. Timeliness of Study Completion - Is the Group able to carry out its planned studies in a reasonable period of time? Is Intergroup collaboration utilized when necessary to satisfy the requirement for timely completion? The Group is entitled to special recognition by peer reviewers when its investigators have played a major role in the development, leadership, or accrual for Intergroup studies. 9. Overall Group Priorities - Are the priorities of the Group appropriate? Are its resources well directed? 10. Developmental Fund Plans - Are the specific plans for the developmental fund appropriate and consistent with the Group's overall goals and priorities? Has the fund been well managed and wisely used in the past? 11. Group Structure and Administration - Is the Group well administered by the Chairperson and the Headquarters staff? Does its organization and infrastructure allow it to meet its major objectives and goals? 12. Group Cohesiveness - Does the Group function as a cohesive research team? 13. Interdisciplinary Coordination - Is there adequate interdisciplinary participation in protocol development and design? Do protocol investigators reflect the modalities utilized? 14. Quality Control - Are the Group's mechanisms of quality control adequate and functioning in a manner which ensures accurate data? 15. Membership - Are the criteria for initial and continuing membership adequate? Do the Group's periodic evaluations of its members result in an optimal membership roster? 16. Companion Research While not required, Group involvement in epidemiologic, diagnostic, cancer control, quality of life, cost effectiveness, and prevention research, especially as it relates to or follows logically from the Group's prime therapeutic mission, is a strength. 17. Patient Advocate Participation - Are there defined plans and roles for patient advocates in the Group? Have they been included in the budget to attend Group meetings? 18. Adequacy of plans to include both genders and minorities and their subgroups as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. 19. Facilities - Are the offices, computer support systems, and overall parent facility commitment adequate to ensure a smoothly functioning Headquarters/Operations Office? Are there any problems with the structural layout that might serve as an impediment to a focused and well coordinated Operations Office? 20. Staff - Are the roles of the Headquarters' staff adequately defined to accomplish the goals of the Group? Is there an adequately defined staff to cover the multiple tasks which are the responsibility of the Operations Office. 21. Budget - Have costs for travel, office supplies, equipment and data management been adequately justified? Are detailed costs of Affiliate members provided? Are budgetary plans submitted for Group meetings and consultant fees? Have costs for the on-site audit plan been accurately detailed? Is there sufficient funding allotted to carry-out the multiple quality control tasks required? VIII.2.B. Statistical and Data Management
Office This portion of the evaluation involves two facets: 1) the performance and capabilities of the Statistical and Data Management Office; and 2) the Group's integration of the Statistical and Data
Management Offices' roles and responsibilities into the overall
research program. 1. Collaboration in Research - Is there adequate statistical and data management collaboration in the development and conduct of the Group's research? 2. Adequacy of Study Design - Are the protocols properly designed statistically? Are the sample sizes adequate to detect realistic and medically important differences? Are the assumptions adequately justified? Is the expected accrual rate carefully estimated? Are the designs used appropriate for the study questions? Are endpoint selections and sequential monitoring plans adequately described and justified? 3. Data Management Are data management procedures adequate, appropriate, and consistent with accepted standards? Are procedures for the verification of data accuracy adequate? Is there clinical review of study data? Do quality assurance and quality control programs exist, including on-site audits that assure high-quality research and patient safety? 4. Statistical Analyses Are analytical techniques, procedures, and policies adequate, appropriate, and consistent with accepted standards? Is there evidence that past publications of the Group Leadership demonstrate thorough and stateoftheart methodology, awareness of problems of multiple analyses, and sufficient independence and lack of bias of statistical collaborators? 5. Key Personnel - Does the research experience and qualifications of the Principal Investigator demonstrate understanding of design and analysis of multi-institutional clinical trials and relevant laboratory studies? While independent research is not required, involvement in research related to the design, conduct and analysis of cancer clinical trials is a strength. 6. Adequacy of Procedures - Are data management procedures adequate, appropriate, and consistent with accepted standards? Are procedures for the verification of data accuracy in place? Is there clinical review of study data? 7. Adequacy of Staff - Are the statistical and data management staff capable of carrying out their special responsibilities? Are the roles of the staff adequately defined to accomplish the goals and meet the responsibilities? Is there an adequate number of personnel to meet the assigned tasks? 8. Facilities - Are the offices, computer hardware, and overall parent facility commitment adequate to assure smooth and efficient function? Are there deficiencies in the structural layout which might serve as an impediment to coordination of Group research efforts? Are computing resources adequate and appropriate to support Group activities as needed? 9. Budget - Have costs for the on-site audit plan (if
relevant) been accurately detailed? Is there sufficient funding
allotted to carry-out the multiple quality control tasks
required? Both scientific and administrative contributions to the Group, and patient accrual and data quality enter into this evaluation. 1. Contributions to Group Science - What are the contributions of the institution's investigators to the Group's research strategies and plans? Do the investigators chair research committees and studies? Although translational research is not required, the ability to conduct pilot trials which can then serve to foster the Group's research goals is a strength. 2. Patient Accrual - Is the record of patient accrual appropriate in the context of Group standards? Are projections for the future reasonable and adequate? Are women and minorities appropriately included as research subjects on Group trials? 3. Key Personnel - Does the research experience and qualifications of the Principal Investigator demonstrate understanding of the conduct of multi-institutional clinical trials in cancer treatment and relevant laboratory studies? 4. Participation in Group Activities and Administration - Do the institution's investigators participate in Group activities and meetings? 5. Interdisciplinary Coordination - To the extent required by the Group's research, is there adequate interdisciplinary cooperation and coordination? 6. Data Quality - Are the recent data complete, accurate, and submitted in a timely fashion? 7. Protocol Compliance - What is the recent record of the quality of protocol participation? 8. Data Management - Are the institution's data management practices and procedures adequate and appropriate? 9. Publication - Do the institution's investigators contribute to publication of Group studies? 11. Adequacy of plans to include both genders and minorities and their subgroups as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. 12. Facilities - Are the treatment facilities adequate to carry out clinical research? Does each Affiliate have a well organized central site which will coordinate the activities of its members? 13. Is there adequate data management and high quality nursing support to meet the patient care and data submission needs of clinical trials? Is the relationship between Affiliate and their Main Members carefully explained, including the responsibilities of the P.I. at each institution? 14. Budget - Have costs for on-site auditing of Affiliates been included (if this is the mechanism chosen by the Group for auditing of Affiliates)? Are travel and equipment costs adequately detailed? Is there adequate justification of personnel costs? |
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