University of Massachusetts Medical School Faculty Publications

UMMS Affiliation

Department of Radiation Oncology; Quality Assurance Review Center

Publication Date

3-15-2013

Document Type

Article

Disciplines

Biostatistics | Clinical Trials | Databases and Information Systems | Health Information Technology | Health Services Administration | Oncology

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.

Keywords

Clinical Trials Cooperative Group Program, National Cancer Institute, Oncology clinical trials, Quality assurance, Radiation oncology

Rights and Permissions

Citation: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

Comments

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.

Related Resources

Link to Article in PubMed

Journal/Book/Conference Title

Frontiers in oncology

PubMed ID

23508883

 
 

To view the content in your browser, please download Adobe Reader or, alternately,
you may Download the file to your hard drive.

NOTE: The latest versions of Adobe Reader do not support viewing PDF files within Firefox on Mac OS and if you are using a modern (Intel) Mac, there is no official plugin for viewing PDF files within the browser window.