A National Cancer Clinical Trials System for the 21st Century Reinvigorating the NCI Cooperative Group Program (2010) / Chapter Skim
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Appendix A: Previous and Ongoing Analyses Undertaken by NCI
Appendix A: Previous and Ongoing Analyses Undertaken by NCI
Pages 235-258
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In addition to these specific recommendations aimed at the Cooperative Group Program, the Program has also been influenced by other working group recommendations, including the Translational Research Working Group (TRWG) report recommendations.
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attract both patients and researchers to participate in clinical trials. The review committee met six times over an 11-month period and included experts from academic research institutions, cancer centers, community oncology practices, cancer patient advocacy groups, and the National Institutes of Health.
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. Table A-1 lists the recommendations of both the Armitage and the CTWG reports, divided into several categories: data collection, standardization, and management; cooperation; process improvement; organizational and structural improvement; accrual; funding; and BOX A-1 Comparison of the Armitage and Clinical Trials Working Group Committee Charges • Armitage Report (1997)
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• Create a national cancer clinical trials information • Data collection should be uniform among the groups: technology infrastructure, fully interoperable with o Use the same protocol guidelines, NCI's Cancer Bioinformatics Grid, to improve the o Simplify the eligibility criteria, cost-effectiveness and comparability of results o Standardize study endpoints, across trials and sites. o Develop a common algorithm for protocol development, • Develop a standards-setting process for o Use the same common data collection forms, measurement, analysis, and reporting of o Develop common toxicity criteria, biomarker data in association with clinical trials o Develop common biostatistical principles, to enhance data comparisons, reduce duplication, o Create a simplified common adverse drug reaction and and facilitate data submission for regulatory adverse event reaction reporting system, and approval.
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• Investigate integration of Phase II trials into the • All groups participating in an inter-Group trial should be able to overall prioritization process to further coordinate conduct direct registration and submit forms directly to the the national clinical trials system. coordinating Group.
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• Treatment trials conducted through the Community Clinical Oncology Program (CCOP) mechanism should be transferred to DCTDC; cancer prevention studies conducted across the NCI clinical trials system should be the responsibility of the newly configured DCPC.
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members of minority groups, medically underserved populations, • Increase community oncologist and patient and elderly individuals in clinical trials and to tailor recruitment advocate involvement in clinical trial design and and retention approaches to address linguistic and cultural prioritization, which will increase patient accrual differences. and better address the practical and quality-of-life • Representatives of patient and high-risk communities need to be concerns in clinical trials.
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aK12 awards support newly trained clinicians appointed by an institution for development of independent research skills and experience in a fundamental science within the framework of an interdisciplinary research and development program. T32 awards enable institutions to make National Research Service Awards to individuals selected by them for predoctoral and postdoctoral research training in specified shortage areas.
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The results of that baseline evaluation are being analyzed by a Working Group of the Clinical Trials and Translational Research Advisory Committee (formerly the Clinical Trials Advisory Committee [CTAC]
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2 A NATIONAL CANCER CLINICAL TRIALS SySTEM BOX A-2 NCI Initiatives in Response to the CTWG Report NCI has launched initiatives in six categories in response to the CTWG report. The objectives and current status of those initiatives are briefly described below. Many of these activities are also described in Chapter 3. Enterprise-wide initiatives aim to enhance coordinated leadership of the clinical trials enterprise by addressing ongoing National Cancer Advisory Board oversight of clinical trials and an integrated NCI organizational structure for clinical trials management. NCI established the Clinical Trials Advisory Committee (CTAC; since renamed the Clinical Trials and Translational Research Advisory Commit tee)
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-compatible clinical information technology, the value added by the Investigational Disease Steering Committee and Scientific Steering Committee processes, the impact of correlative science funding and standardization, the value and use of standardized clinical trial tools, and the cost savings achieved by shifting patient accrual to highly accruing, more efficient sites. Multiple sources of data were used for the baseline feasibility analysis, including interviews, database analyses, and reviews of factual information in documents.
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In addition, the group recommended that the databases include earlier time points in concept development, as well as fields for trial complexity and patient eligibility criteria to facilitate the interpretation of the accrual data. To assess the impact of the changes on fostering collaboration, the group suggested that future interviews examine collaboration in trial design and that NCI develop a way to track collaborative trial efforts in the clinical trials databases.
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This timeline excludes industry negotiations, arranging drug supply, and IRB and FDA approval; however, if the protocol is not activated within 18 months, it will be terminated. TRANSLATIONAL RESEARCH WORkING GROuP REPORT The TRWG was established in June 2005 under the auspices of the National Cancer Advisory Board and was charged with evaluating the current status of the NCI's investment in translational research, envisioning its future, and developing recommendations and implementation plans to realize that vision.
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2 A NATIONAL CANCER CLINICAL TRIALS SySTEM BOX A-3 Operational Efficiency Working Group Recommendations Cooperative Group Process Improvement • ecommendation 1: Group-specific action plan to achieve OEWG target R timeline o Potential staffing changes ▪ Physician senior protocol officers ▪ Nonphysician trial development managers ▪ Specialist medical writers o Performance of trial development steps in parallel o Direct, coordinated interactions to resolve issues o Project management and protocol tracking tools • Recommendation 2: CTEP action plan to achieve OEWG target timeline o Project managers ▪ Manage overall protocol review, revision, and approval process ▪ Facilitate interactions between CTEP and the Cooperative Groups o oordinated NCI scientific review to identify all issues at time of initial C concept review o rompt communication of critical issues in advance of formal written P reviews o Streamlined methods for communicating comments o Differentiation of advisory comments from those requiring a response o Project management and protocol tracking tool • ecommendation 3: Collaborative Group-CTEP process for concept and R protocol revision o Direct, coordinated interactions to resolve issues o High priority for devotion of time to issue resolution o Resolution of fundamental aspects of study design at concept stage o ocus of interactions at protocol stage on mechanics of completion of F protocol embodying an agreed-upon concept ▪ Prompt communication and resolution of major differences ▪ Minimization of time discussing noncritical differences of opinion ▪ Minimization of time and effort for routine or pro forma revisions o Rapid arbitration for any issues not resolved quickly • ecommendation 4: Development of approaches to reward performance R against timelines o stablish a comprehensive, reliable system for reporting timeline perfor E mance for each step in trial activation process o ollect timeline performance data for at least 1 year and assess accuracy C and value of the data and reports o nalyze performance data by individual Cooperative Groups and across A the Group system in comparison with target timelines o Joint Cooperative Group-NCI deliberations concerning ▪ Linking incentives to Group-specific timeline performance ▪ Incorporating performance against timeline targets o TEP inclusion of timeline performance in its annual staff performance C evaluations
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2 APPENDIX A Early Drug Development Phase II Trial Activation Process Improvement • Recommendation 5: CTEP action plan to achieve OEWG target timeline o Project managers ▪ Management of overall protocol review, revision, and approval process ▪ Facilitation of interactions among CTEP, principal investigators, and industry o Teleconferences to resolve issues for LOIs on hold o Prompt communication of disapprovals in advance of review letter o Streamlined methods for communicating comments o Differentiation of advisory comments from those requiring response o Project management and protocol tracking tools • ecommendation 6: Collaborative Group, N01 research and development R contracts, CTEP process for LOI and protocol revision o irect, coordinated interactions to resolve issues (within 14 days of LOI D review) o High priority on devoting time to issue resolution o Resolution of fundamental aspects of study design at LOI stage o ocus of interactions at protocol stage on mechanics of completing a pro F tocol embodying an agreed-upon LOI ▪ Prompt communication and resolution of major differences ▪ Minimization of time spent discussing noncritical differences of opinion ▪ Minimization of time and effort for routine or pro forma revisions o Rapid arbitration for any issues not resolved quickly Cancer Center Process Improvement • ecommendation 7: Cancer center-specific action plan to achieve R OEWG target timeline o Potential action plan elements ▪ Specialist medical writers ▪ Direct, coordinated interactions to resolve differences ▪ Project management and protocol tracking tool o Center-specific timeline targets ▪ odification of OEWG target to reflect specific cancer center M environment ▪ Analysis of targets for reasonableness by cancer center directors and NCI ▪ Reporting of timeline data against target on an annual basis ▪ Annual report on actions taken against centers performing below expectations o Funding sources ▪ Allowance for explicit use of Cancer Center Support Grant (CCSG)
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. In addition, the TRWG constructed six developmental pathways to describe the decision-making points and processes along which translational research occurs for six domains: biospecimen-based risk assessment devices, image-based risk assessment agents
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. The TRWG report expanded the scope of the CTAC committee to include translational research, noting that CTAC
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Other report recommendations focused on prioritizing translational research activities at NCI, providing better project management of translational research activities, establishing enhanced biospecimen repositories and analytical methods, and ensuring the provision of training and career incentives for early translational research.
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to include translational research responsibilities; expansion of Coordinating Center for Clinical Trials to include Translational Research Support Team • Designate a specific portion of the NCI budget for early translational research. • Develop a set of award codes that accurately capture • Pilot project with NCI's Division of Extramural Activities to the nature and scope of the early translational code grants for translational research on the basis of the research portfolio.
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• Establish a special translational research acceleration • Pilot project to establish a STRAP for the immune response project (STRAP) to advance prioritized early modifier pathway translational research opportunities.
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• Enhance interactions and collaborations with foundations and advocacy groups to advance early translational research. • Enhance training and career incentives for early translational research.
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Report of the Translational Research Working Group of the National Cancer Advisory Board. Bethesda, MD: National Cancer Institute.
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2008. The Translational Research Working Group developmental pathway for anticancer agents (drugs or biologics)
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