Future vision for the quality assurance of oncology clinical trials
AuthorsFitzgerald, Thomas J.
Bosch, Walter R.
Curran, Walter J.
Followill, David S.
Galvin, James M.
King, Steven R.
Knopp, Michael V.
Michalski, Jeff M.
Saltz, Joel H.
Schnall, Mitchell D.
UMass Chan AffiliationsQuality Assurance Review Center
Department of Radiation Oncology
Document TypeJournal Article
KeywordsClinical Trials Cooperative Group Program
National Cancer Institute
Oncology clinical trials
Databases and Information Systems
Health Information Technology
Health Services Administration
MetadataShow full item record
AbstractThe 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.
SourceFitzgerald 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
Permanent Link to this Itemhttp://hdl.handle.net/20.500.14038/29946
Related ResourcesLink to Article in PubMed
RightsCopyright 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.