National Cancer Institute
National Cancer Institute U.S. National Institutes of Health

CTWG Recommendations

''These initiatives integrate the individually strong components of the current system into a cross-disciplinary, scientifically driven, cooperative research effort.'' James H. Doroshow, M.D., CTWG Chairman

The mission of the CTWG was to recommend ways the NCI-supported national clinical trials enterprise should be transformed to realize the promise of molecular oncology in the 21st century.

To meet this challenge, the CTWG first reached consensus on four critical goals for designing a more efficient national system for clinical trials conducted or supported by NCI: (1) better coordination; (2) prioritization based on solid science and the needs of patients; (3) standardized tools and procedures; and (4) improved operational efficiency. These four goals provide a framework for 22 initiatives recommended by the CTWG.

Coordination Initiatives: to improve coordination and cooperation among the functionally diverse components of the current system, including industry and federal regulatory agencies.

Prioritization/Scientific Quality Initiatives: to improve prioritization and scientific quality by developing an open and transparent process for the design and prioritization of clinical trials that are science driven and meet the needs of patient care.

Standardization Initiatives: to improve standardization of tools and procedures for trial design, data capture, data sharing, and administrative functions to minimize duplication of effort and to facilitate development of a shared infrastructure to support an integrated national cancer clinical trials network.

Operational Efficiency Initiatives: to improve operational efficiency by increasing the rate of patient accrual and reducing operational barriers so that trials can be initiated and executed in a timely, cost-effective manner.

Enterprise-Wide Initiatives: 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.

Informatics Initiatives: to define, design, build, and deliver a comprehensive clinical trials informatics infrastructure that will serve all of the critical stakeholders.

Evaluation Plan: to compare the baseline to the future based on system outcome measures (overall output) and system performance measures (performance of individual CTWG initiatives).