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Future vision for the quality assurance of oncology clinical trials

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
... show 8 more
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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.

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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

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10.3389/fonc.2013.00031
PubMed ID
23508883
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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.
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