"Restructuring the National Cancer Institute Clinical Trials Enterprise," the report developed by CTWG, provides a detailed blueprint to revamp the conduct of all NCI-sponsored clinical trials in the light of molecular medicine and other emerging 21st century technologies. The report was adopted today by NCAB. (See story.)

The 22 CTWG recommendations below include: proposals for fundamental changes in how the NCI clinical trials system operates; initiatives to expand or enhance activities already underway; and two NCI-wide initiatives to establish the organizational plan and structure to make the redesign continuous, efficient, and effective. The full report, which can be viewed at http://integratedtrials.nci.nih.gov, also includes implementation plans, timelines, and budgets for each initiative.

Coordination Initiatives

• Create a comprehensive database containing information on all NCI-funded clinical trials to facilitate better planning and management across clinical trial venues.
• Realign NCI and academic incentives to promote collaborative team science.
• Increase cooperation between NCI, FDA, and industry to enhance the focus and efficiency of oncology drug development.
• Expand awareness of the NCI-FDA expedited approval process to speed trial initiation.
• Work with the Centers for Medicare & Medicaid Services (CMS) to identify clinical studies that address both NCI and CMS objectives, and for which CMS may be able to reimburse some routine and investigational costs.

Prioritization/Scientific Quality Initiatives

• Create an Investigational Drug Steering Committee to work with NCI to enhance the design and prioritization of early-phase drug development trials.
• Create a network of Scientific Steering Committees, which leverage current Intergroup, Cooperative Group, Specialized Programs of Research Excellence (SPORE), and Cancer Center structures, to work with NCI in the design and prioritization of phase III trials to better allocate scarce resources, improve scientific quality, and reduce duplication.
• Increase community oncologist and patient advocate involvement in clinical trial design and prioritization to improve the rate of patient accrual, and better address practical and quality-of-life concerns in the design of trials.
• Develop a funding and prioritization process to ensure that critical correlative science and quality-of- life studies can be conducted in a timely manner in association with clinical trials.
• Develop a standards-setting process for the measurement, analysis, and reporting of biomarker data in association with clinical trials to enhance data comparisons, reduce duplication, and facilitate data submission for regulatory approval.
• Investigate integration of phase II trials into the overall prioritization process to further coordinate the national clinical trials system.

Standardization Initiatives

• Create, in partnership with the extramural cancer research community, a national cancer clinical trials information technology infrastructure fully interoperable with NCI's cancer Bioinformatics Grid to improve cost-effectiveness and comparability of results across trials and sites.
• In consultation with industry and FDA, develop standard case report forms incorporating common data elements to improve information sharing among cancer researchers and optimize data requirements.
• Build a credentialing system for investigators and sites recognized by NCI and industry to allow faster trial initiation and keep the investigative community abreast of legal, safety, and regulatory changes.
• Develop commonly accepted clauses for clinical trial contracts with industry to reduce the lead-time needed to open trials.

Operational Efficiency Initiatives

• Restructure the phase III funding model to promote rapid patient accrual rates and cost-effectiveness.
• Reduce institutional barriers to timely trial initiation.
• Increase patient and public awareness and understanding of clinical trials.
• Increase minority patient access to clinical trials to improve the participation of underserved and underrepresented populations.
• Promote adoption of the NCI Central Institutional Review Board facilitated review process to reduce the time and resources needed to open trials at individual sites.

Enterprise-Wide Initiatives

• Create a Clinical Trials Oversight Subcommittee of the NCAB to advise the NCI Director on conduct of clinical trials across the Institute.
• Develop a coordinated NCI organizational structure to manage the entire clinical trials enterprise supported by the Institute.

By Addison Greenwood