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In Reply

Owen Graduate School of Management and Engineering Management Program, Vanderbilt University, Nashville, TN

Alan Sandler

Vanderbilt-Ingram Cancer Center, Vanderbilt University, Nashville, TN

We would like to thank Dr Steensma for his thoughtful comments regarding our article, "Process to Activate Phase III Clinical Trials in a Cooperative Oncology Group: The Case of Cancer and Leukemia Group B."¹ We share the view that other cooperative groups, given the similar bureaucratic complexities, may have a similar timetable for protocol activation. We are currently in the process of evaluating two other National Cancer Institute (NCI) –funded cooperative oncology groups and hope to have these data available for publication in the near future. In addition, now that the issues have been highlighted in a cooperative oncology group, we are embarking on a study of the processes that the NCI Cancer Therapy Evaluation Program employs in working with the cooperative groups to review and activate protocols. The leadership at the NCI Cancer Therapy Evaluation Program is to be commended for allowing us to study the situation.

As Dr Steensma aptly notes, it is impossible to know the number of "zombies" in the system, that is, those study proposals that have been approved for development but have never been activated. Zombies are notorious in other industries for demanding excessive amounts of time, energy, and money.

Finally, one of the purposes of our article was to highlight the "Oliphaunt in the room" and "to light a fire" under those with the authority and the responsibility to reduce it to a reasonable size. We certainly agree that reform requires collaboration and commitment among all parties to improve the system. If not, we fear that oncology clinical trials in the United States as we know them today may be following the same path as that of the United States automotive industry (ie, swamped by international competition, historical complacency, and dissatisfied customers). As Dr Steensma states, the need is overwhelming.

AUTHORS’ DISCLOSURES OF POTENTIAL CONFLICTS OF INTEREST

Although all authors completed the disclosure declaration, the following authors or their immediate family members indicated a financial interest. No conflict exists for drugs or devices used in a study if they are not being evaluated as part of the investigation. For a detailed description of the disclosure categories, or for more information about ASCO's conflict of interest policy, please refer to the Author Disclosure Declaration and the Disclosures of Potential Conflicts of Interest section in Information for Contributors.

Employment: N/A Leadership: N/A Consultant: N/A Stock: N/A Honoraria: N/A Research Funds: David Dilts, NIH; Alan Sandler, NIH Testimony: N/A Other: N/A

REFERENCE

1. Dilts DM, Sandler AB, et al: Processes to activate phase III clinical trials in a cooperative oncology group: The case of cancer and Leukemia Group B. J Clin Oncol Vol 24:4553-4557, 2006[Abstract/Free Full Text]

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Related Correspondence

• Processes to Activate Phase III Clinical Trials in a Cooperative Oncology Group: The Elephant Is Monstrous
  David P. Steensma
  JCO 2007 25: 1148 [Full Text]

This Article Full Text (PDF) Purchase Article View Shopping Cart Alert me when this article is cited Alert me if a correction is posted Services Email this article to a colleague Similar articles in this journal Alert me to new issues of the journal Save to my personal folders Download to citation manager Rights & Permissions Citing Articles Citing Articles via Google Scholar Google Scholar Articles by Dilts, D. Articles by Sandler, A. Search for Related Content PubMed Articles by Dilts, D. Articles by Sandler, A. Related Articles Related Correspondence Social Bookmarking                            What's this?