National Cancer Institute
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Outcomes Research Branch
Cancer Control and Population Sciences


NCI Cancer Therapy Evaluation Program (CTEP) Evaluation Projects

NCI is currently restructuring the way randomized treatment clinical trials are proposed, reviewed, and implemented. In doing so, the Institute is capitalizing on opportunities available though Internet-based innovations. NCI's Division of Cancer Treatment and Diagnosis has solicited the services of the Outcomes Research Branch (ORB) to evaluate several key projects in this area:

  • State of the Science Meetings. NCI's State-of-the-Science meetings disseminate the most recent cancer research results to a potentially vast audience of scientists through multiple media, including the State-of-the-Science Web site. ORB is evaluating the efficiency and effectiveness of new ways to promote and manage NCI-sponsored treatment trials, including the contribution of the State-of-the-Science Web site in facilitating dissemination. With NCI's Cancer Therapy Evaluation Program (CTEP) and Research Triangle Institute (RTI), ORB has developed Internet-based questionnaires to solicit cancer researchers, oncology fellows, and State-of-the-Science Web site users' evaluations of the site.
  • Concept Evaluation Panel (CEP). To strengthen the science behind clinical trials development, NCI is investigating new ways for panels to evaluate Phase III clinical trial proposals. Traditionally, NCI staff have conducted reviews of NCI-sponsored Cooperative Group trials. Today, two-thirds of the CEP members are not affiliated with NCI. Rather, members include clinicians, basic scientists, patient advocates, statisticians, and other oncology professionals. These panels meet monthly through an Internet-assisted conference call that facilitates broad participation without delaying the review process. A Web-based teleconference allows panelists around the country to review and vote on proposals posted on a password-protected site. Together, CTEP, ORB, and RTI are evaluating the advantages and disadvantages of an electronic system for reviewing and scoring proposals and whether Web-based teleconferencing is a reasonable substitute for face-to-face meetings.
  • Centralized Institutional Review Board (CIRB). In the case of multi-center studies, local Institutional Review Boards (IRBs), which can number in the dozens or hundreds, must each review and approve the same protocol. To reduce this burden and more quickly reach targets for the number of patients enrolled in trials, NCI and the Office for Human Research Protections have begun a pilot project to develop a centralized model of human subjects protection for cancer patients participating in multi-center clinical trials. This pilot involves establishing an NCI central IRB to work with local IRBs. The NCI Cancer Therapy Evaluation Program and ORB are planning an evaluation of the Centralized Institutional Review Board's ability to achieve the highest standards of human subject protection and to reduce the administrative burden on local IRBs and investigators.

Last modified:
08 Jan 2008
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