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Journal of Clinical Oncology, Vol 25, No 10 (April 1), 2007: pp. 1288 © 2007 American Society of Clinical Oncology. DOI: 10.1200/JCO.2006.10.3200
CT2—The Clinical Trials Control Tower: Overcoming Barriers to Opening Oncology Clinical TrialsWinship Cancer Institute, Emory University, Atlanta, GA To the Editor: We read the article by Dilts and Sandler1 with interest, and applaud the authors' meticulous efforts and candor in illuminating the barriers that exist to opening oncology clinical trials in an academic health center setting. As a matrix cancer center reliant on interaction with other departments to execute the opening of clinical trials, the Winship Cancer Institute at Emory University (Atlanta, GA) realizes similar challenges to those reported at Vanderbilt. Several of these steps are difficult to circumvent in an academic health care center, and we believe that these processes make it more challenging for academic centers to attract pharmaceutical industry-sponsored clinical trials. We fully agree with the authors that overcoming the barriers to opening oncology clinical trials "is of critical importance for maintenance of core oncology research capabilities in the United States."1 At the Winship Cancer Institute, we have begun to develop and implement a method to improve the efficiency with which we open clinical trials. We have termed this process the CT2, the clinical trials control tower, since the management of clinical trials is somewhat akin to that of airport traffic, a process that has been described as managing controlled chaos. We have employed a program coordinator to electronically track the progress of each protocol from inception to closure, much like the tracking of moving aircraft on a radar screen. This control tower monitors and manages the functions of the key parties involved in the initiation of each protocol (the study investigator, the clinical trials office, other institutional departments and committees, and the study sponsor), and provides the communication within and between these parties necessary to streamline the progress of each protocol through the clinical trial initiation process. Clinical research can only succeed in increasing efficiency if we identify stop-gaps in the current process, and learn how to improve these procedures by critically evaluating their current quality and efficiency. Our tracking efforts show that we experience similar obstacles to those seen by the Vanderbilt Cancer Center (Nashville, TN) and its affiliates. In conclusion, we fully concur with the findings of this enlightening study regarding the barriers that exist in academia to opening oncology clinical trials. We believe academic institutions offer outstanding resources for the pharmaceutical industry to conduct clinical trials, but that we must strive to function more efficiently to attract the business of pharmaceutical sponsors. We hope that our CT2 model will facilitate a leaner process that will expedite the opening of both industry-sponsored and investigator-initiated clinical trials, ultimately providing more treatment options for cancer patients. AUTHORS' DISCLOSURES OF POTENTIAL CONFLICTS OF INTEREST The authors indicated no potential conflicts of interest. REFERENCE
1. Dilts DM, Sandler AB: Invisible barriers to clinical trials: The impact of structural, infrastructural, and procedural barriers to opening oncology clinical trials. J Clin Oncol 24:4545-4552, 2006
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Copyright © 2007 by the American Society of Clinical Oncology, Online ISSN: 1527-7755. Print ISSN: 0732-183X
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