Among the barriers to physician participation in clinical trials are the time-consuming tasks of constructing protocols, having them reviewed, and enrolling patients. One of the goals of the new system is to provide tools that will simplify these tasks and at the same time improve the quality of the research.

Cancer Trials Support Unit (CTSU)

The CTSU is designed to streamline and centralize many administrative, financial, and data collection tasks associated with clinical trials. The CTSU will provide participating physicians with a single access point to the NCI's entire phase III clinical trials system, facilitating access to protocols, training, and educational information. Highlights of the fully developed system will include:

• Cross-Group registration of patients. Physicians can register patients on adult Cooperative Group trials in lung, genitourinary, colorectal, and breast cancers and leukemia, even if they are not members of the Group conducting the trial.
• Online patient registration, eligibility assessment, and reporting of data that will use a common format and state-of-the-art data management systems.
• A coordinated auditing system that will eliminate multiple quality assurance audits for research personnel participating in more than one Cooperative Group.
• Centralization of administrative tasks, including credentialing and verification of Institutional Review Board approval for all investigators participating in the Cooperative Groups and the CTSU.
• The CTSU opened in July, 2000, for Cooperative Group members. If the initial experience is successful, oncologists not affiliated with a Group will be encouraged to participate as well.

Informed Consent

New recommendations for informed consent documents have been developed to improve patients' understanding of cancer clinical trial participation. The recommendations were developed by a group that included research physicians and nurses, patient advocates, IRB members, communications and legal experts, ethicists, representatives of the pharmaceutical industry, as well as the staff of the NIH and the FDA. The guidelines package includes:

• Specific recommendations for information to be included in informed consent documents for cancer clinical research.
• A guide for the provision of supplemental materials.
• A template form that investigators can use to develop informed consent documents.
• Sample completed informed consent documents using the template.

Central Institutional Review Board (IRB)

In the case of multi-center studies, each local IRB--these can number in the dozens or hundreds--must review and approve the same protocol. To reduce this burden, the NCI and the Office of Human Research Protections (OHRP) are jointly undertaking a pilot project to develop a centralized model of human subjects protection for cancer patients participating in multi-center clinical trials. This pilot involves the establishment of an NCI central IRB (CIRB) working in tandem with local IRBs to protect human subjects.

• During 2000, NCI appointed a diverse and expert group of consumer advocates, ethicists, oncology professionals and others to serve as CIRB members, and also enlisted the participation of 22 local IRBs into the pilot. SOPs were developed. OHRP and NCI signed a Cooperative Project Assurance.
• The CIRB began reviewing protocols in January 2001. Plans are underway to expand both the menu of protocols for CIRB review and the number of sites participating in the pilot.
• For more information, e-mail: goldbergj@mail.nih.gov.

Protocol Assembly

The NCI has created a series of electronic forms, templates, and databases to make it easier for investigators to submit and develop ideas for protocols and streamline the review process. Some of these serve investigators directly by eliminating paperwork and speeding up the protocol development process. Others help the NCI staff track information about trials and contribute to the overall efficiency of protocol management. Resources available for investigators include:

• A template for a letter of intent for phase I or II trials.
• A template for submitting a concept for a phase III trial.
• A template to guide the writing of protocols.

Clinical Trials Monitoring Branch Audit Information System (CTMBAIS)

Implemented in January 1999, CTMBAIS is a Web-based information system which permits online submission of all data collected during quality assurance audits of NCI-sponsored Cooperative Group clinical trials. The system links the Cooperative Groups, CTMB, and the Clinical Trials Monitoring Service to coordinate audit-related activities. It includes:

• Maintenance of comprehensive membership rosters for each Cooperative Group.
• Submission of audit schedules.
• Acknowledgment of preliminary audit reports and transmission of final reports.
• Tracking and follow-up of responses to audit findings.
• For more information, e-mail: ncictephelp@ctep.nci.nih.gov.

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