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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.
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