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    Future vision for the quality assurance of oncology clinical trials

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    Authors
    Fitzgerald, Thomas J.
    Bishop-Jodoin, Maryann
    Bosch, Walter R.
    Curran, Walter J.
    Followill, David S.
    Galvin, James M.
    Hanusik, Richard
    King, Steven R.
    Knopp, Michael V.
    Laurie, Fran
    O'Mear, Elizabeth
    Michalski, Jeff M.
    Saltz, Joel H.
    Schnall, Mitchell D.
    Schwartz, Lawrence
    Ulin, Kenneth
    Xiao, Ying
    Urie, Marcia
    Show allShow less
    UMass Chan Affiliations
    Quality Assurance Review Center
    Department of Radiation Oncology
    Document Type
    Journal Article
    Publication Date
    2013-03-15
    Keywords
    Clinical Trials Cooperative Group Program
    National Cancer Institute
    Oncology clinical trials
    Quality assurance
    Radiation oncology
    Biostatistics
    Clinical Trials
    Databases and Information Systems
    Health Information Technology
    Health Services Administration
    Oncology
    Show allShow less
    
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    Abstract
    The National Cancer Institute clinical cooperative groups have been instrumental over the past 50 years in developing clinical trials and evidence-based process improvements for clinical oncology patient care. The cooperative groups are undergoing a transformation process as we further integrate molecular biology into personalized patient care and move to incorporate international partners in clinical trials. To support this vision, data acquisition and data management informatics tools must become both nimble and robust to support transformational research at an enterprise level. Information, including imaging, pathology, molecular biology, radiation oncology, surgery, systemic therapy, and patient outcome data needs to be integrated into the clinical trial charter using adaptive clinical trial mechanisms for design of the trial. This information needs to be made available to investigators using digital processes for real-time data analysis. Future clinical trials will need to be designed and completed in a timely manner facilitated by nimble informatics processes for data management. This paper discusses both past experience and future vision for clinical trials as we move to develop data management and quality assurance processes to meet the needs of the modern trial.
    Source
    Fitzgerald TJ, Bishop-Jodoin M, Bosch WR, Curran WJ, Followill DS, Galvin JM, Hanusik R, King SR, Knopp MV, Laurie F, O'Meara E, Michalski JM, Saltz JH, Schnall MD, Schwartz L, Ulin K, Xiao Y, Urie M. Future vision for the quality assurance of oncology clinical trials. Front Oncol. 2013;3:31. doi: 10.3389/fonc.2013.00031. Link to article on publisher's site
    DOI
    10.3389/fonc.2013.00031
    Permanent Link to this Item
    http://hdl.handle.net/20.500.14038/29946
    PubMed ID
    23508883
    Related Resources
    Link to Article in PubMed
    Rights
    Copyright 2013 FitzGerald, Bishop-Jodoin, Bosch, Curran, Followill, Galvin, Hanusik, King, Knopp, Laurie, O'Meara, Michalski, Saltz, Schnall, Schwartz, Ulin, Xiao and Urie. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits use, distribution and reproduction in other forums, provided the original authors and source are credited and subject to any copyright notices concerning any third-party graphics etc.
    ae974a485f413a2113503eed53cd6c53
    10.3389/fonc.2013.00031
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