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Clinical Trials Working Group (CTWG) Implementation

In June 2005, the National Cancer Institute's (NCI) Clinical Trials Working Group (CTWG) issued a report to the National Cancer Advisory Board titled Restructuring the National Cancer Clinical Trials Enterprise. The NCI Center for Biomedical Informatics and Information Technology (CBIIT) was subsequently asked to implement four informatics-focused initiatives presented in the CTWG's report. These four informatics-focused initiatives will be carried out through the NCI’s cancer Biomedical Informatics Grid (caBIG®), within the Clinical Trials Management Systems (CTMS) Workspace.

The four informatics initiatives that are being implemented by the CTMS Workspace are:

1. Development of a database to serve as a central source of data for reporting and information sharing on all NCI-sponsored clinical trials. Data submitted to the database will be available to all properly identified users through a unified, web-based interface or portal.

2. Development and implementation of a plan that will enable all NCI-supported internal and external clinical trials systems to seamlessly share standardized information across the NCI cancer research community in a manner that is fully interoperable with NCI’s caBIG®.

3. Establishment of a core library of harmonized and standardized Phase II and III Case Report Forms (CRFs), incorporating Common Data Elements (CDEs), through stakeholder consensus (including industry and FDA).

4. A secure repository that is accepted by NCI, NCI-sponsored institutions and industry as a single repository for all required and current credentials for investigators and clinical trial sites to conduct clinical trials.

In implementing the four CTWG informatics initiatives, the CTMS Workspace will:

  • Leverage the current collaborative efforts and infrastructure of the caBIG® program.
  • Expand the participation of cancer clinical trials stakeholder organizations including Cancer Centers, Cooperative Groups, Community Clinical Oncology Programs (CCOPs) and Specialized Programs Of Research Excellence (SPOREs) as well as clinical-trials-focused divisions, branches, centers and programs within the NCI.
  • Expand participation of cancer clinical trials researchers including, but not limited to, Principal Investigators, Biostatisticians, Clinical Research Nurses, Study Coordinators and Data Managers.
  • Realize the vision and achieve the goals of the CTWG Report through the coordinated application of best practices in software engineering and project management.

Examples of new tools and technologies to address the CTWG's recommendations include a core library of harmonized and standardized Phase II and III electronic case report forms (eCRFs) to speed data capture and enable the comparison and aggregation of information across the NCI's clinical trials portfolio, a clinical trials database that will contain information on all NCI-supported clinical trials, and an investigator and site credential repository. The CTMS Workspace contains more information about these and other tools and technologies to address the CTWG's recommendations.


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last modified 02-21-2009 04:46 PM