Implementing a National Cancer Clinical Trials System for the 21st Century Workshop Summary (2011) / Chapter Skim
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B Executive Summary of A National Cancer Clinical Trials System for the 21st Century
B Executive Summary of A National Cancer Clinical Trials System for the 21st Century
Pages 105-108
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From page 105... ...
Publicly funded clinical trials play a vital role by addressing questions that are important to patients but are less likely to be top priorities of industry, which has an important primary focus on new drug development and Food and Drug Administration (FDA) registration.
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From page 106... ...
The committee concluded that a robust, standing cancer clinical trials network is essential to effectively translate discoveries into clinical benefits for patients. There are hundreds of cancer therapies in development and a continuous need for design and implementation of new clinical trials, so it would be highly inefficient to fund and develop infrastructures and research teams separately for each new trial.
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From page 107... ...
focused on four broad goals to enhance the value of national Cooperative Group clinical trials in cancer: Consolidation and Efficiency. Improve the efficiency and reduce the average time for the design and launch of innovative clinical trials by consolidating functions, committees, and Cooperative Groups; streamlining oversight processes; facilitating collaboration; and streamlining and standardizing data collection and analysis.
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From page 108... ...
Cover the cost of patient care in clinical trials a Front office operations refer primarily to the Cooperative Group scientific committees and statistical offices, which are responsible for activities such as trial design, prioritization, and data analysis. b Back office operations refer to administrative structures and activities that include such things as data collection and management, data queries and reviews, patient registration, audit functions, case report form processing, image storage and retrieval, drug distribution, credentialing of sites, and funding and reimbursement for patient accrual.
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