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Invisible Barriers to Clinical Trials: The Impact of Structural, Infrastructural, and Procedural Barriers to Opening Oncology Clinical Trials

David M. Dilts, Alan B. Sandler

From the Center for Management Research in Healthcare; Management of Technology Program; and the Vanderbilt-Ingram Cancer Center, Vanderbilt University, Nashville, TN

Address reprint requests to David M. Dilts, PhD, MBA, Owen Graduate School of Management, 401 21st Ave S, Nashville, TN 37203; e-mail: david.dilts{at}vanderbilt.edu

PURPOSE: To investigate the administrative barriers that impact the opening of clinical trials at the Vanderbilt-Ingram Cancer Center (VICC) and at VICC Affiliate Network (VICCAN) sites.

METHODS: VICC, a National Cancer Institute–designated comprehensive cancer center, and three VICCAN community practice sites were studied. Methodology used was identification and mapping of existing processes and analysis of historical timing data.

RESULTS: At course granularity, the process steps required at VICC and VICCAN main office plus local sites are 20 v 17 to 30 steps, respectively; this gap widens with finer granularity, with more than 110 v less than 60 steps, respectively. Approximately 50% of the steps are nonvalue added. For example, in the institutional review board (IRB) process, less than one third of the steps add value to the final protocol. The numbers of groups involved in the approval processes are 27 (VICC) and 6 to 14 (VICCAN home office and local sites). The median times to open a trial are 171 days (95% CI, 158 to 182 days) for VICC and 191 days (95% CI, 119 to 269 days) for the VICCAN sites. Contrary to expectations, the time for IRB review and approval (median, 47 days) is the fastest process compared with the scientific review committee review and approval (median, 70 days) and contracts and grants review (median, 78.5 days). Opening a cooperative group clinical trial is significantly (P = .05) more rapid because they require fewer review steps.

CONCLUSION: There are numerous opportunities to remove nonvalue-added steps and save time in opening clinical trials. With increasing numbers of new agents, fewer domestic principal investigators, and more companies off-shoring clinical trials, overcoming such barriers is of critical importance for maintenance of core oncology research capabilities in the United States.

Supported by a Vanderbilt University Discovery Grant and by a Vanderbilt University Medical Center Discovery Grant.

Presented in part at the 40th Annual Meeting of the American Society of Clinical Oncology, New Orleans, LA, June 5-8, 2004; National Cancer Institute Clinical Trials Working Group Meeting, Chicago, IL, November 17, 2004.

Authors' disclosures of potential conflicts of interest and author contributions are found at the end of this article.

Related Correspondence

• CT2—The Clinical Trials Control Tower: Overcoming Barriers to Opening Oncology Clinical Trials
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  JCO 2007 25: 1288 [Full Text]
• Improving the Institutional Submission and Approval Process for Clinical Research Protocols in Oncology
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  JCO 2007 25: 1632-1633 [Full Text]
• Barriers to Clinical Trials Vary According to the Type of Trial and the Institution
  Rangaswamy Govindarajan, James W. Young, Cherie L. Harless, and Laura F. Hutchins
  JCO 2007 25: 1633-1634 [Full Text]

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