The CTSU will allow web-based, online patient registration, eligibility assessment, and reporting of data on phase III trials. It will also facilitate education and training for medical staff along with referral and clinical trials information for patients. Westat vice president Steve Durako said the company aims to have a CTSU website ready for protocol and training materials in 3 to 6 months and that the first patients could be enrolled online in 6 to 9 months.
For investigators, the new CTSU means enhanced access to clinical trials and fewer redundant activities among the NCI-sponsored Cooperative Clinical Trials Groups, said Robert Comis, M.D., president of the Coalition of National Cancer Cooperative Groups, Inc., Philadelphia. Through a subcontract, the Coalition will help develop the CTSU in areas such as credentialing of investigators, auditing, education, and regulatory matters. Support for systems development will be provided by Oracle Corporation, Redwood City, Calif.
Michaele Christian, M.D., associate director of NCI's Cancer Therapy Evaluation Program, called the CTSU a cornerstone in the new clinical trials system, and added that it will dramatically change the way NCI's large treatment trials are organized (News, Feb. 17, 1999, p. 312). More information is available at http://ctep.info.nih.gov (click on clinical trials support initiatives).
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