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In Reply

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

Alan B. Sandler

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

We thank Govindarajan et al and Camacho et al for their thoughtful comments on our article "Invisible Barriers to Clinical Trials: The Impact of Structural, Infrastructural, and Procedural Barriers to Opening Oncology Clinical Trials."¹ We find it encouraging that others have embarked on efforts to define barriers at their local institutions and have attempted to streamline their processes.

We agree with Govindarajan et al in that there may be differences in the steps involved in opening investigator-initiated, industry-sponsored, and cooperative group trials. We have additional research underway at other National Cancer Institute–designated comprehensive cancer centers and hope to publish these results soon. One observation is that a high degree of heterogeneity exists in the ordering and the number of process steps among comprehensive cancer centers; however, the barriers to opening clinical trials appear to be consistent.

While it is true that the time required to open a cooperative group trial at a single institution may be faster than that of an investigator-initiated or industry-sponsored trial, it is important to remember that this time does not included the more than 2 years median time required to activate a clinical trial at a cooperative group.²

We also applaud the efforts of Camacho et al in identifying and evaluating barriers to opening phase I clinical trials at their institution. We agree that having a project champion is an efficacious strategy to deal with the multiple steps required for study opening and this result has been found in numerous industries.³ Clearly a parallel approach is generally better than an approach in series; however, a single process may be the bottleneck. For example, our article highlights the fact that the contracting and grants process and not the institutional review board process was the rate limiting factor in the opening of clinical trials.

Finally, as both letters refer to time studies, we would like to clarify two points of potential confusion. First, our data was presented in total calendar time, not work days. Second, while the activation of a study is relatively easy to identify, the beginning step in the process (ie, when the clock starts) can vary by institution. Hence, one should approach multiple institution time comparisons with caution.

AUTHORS’ DISCLOSURES OF POTENTIAL CONFLICTS OF INTEREST

The authors indicated no potential conflicts of interest.

REFERENCES

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[Abstract/Free Full Text]

2. Dilts DM, Sandler AB, Baker M, 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 24:4553-4557, 2006[Abstract/Free Full Text]

3. Dilts, DM. Studies of Leading-Edge Integration in Organizations, in Consortium Advanced Manufacturing International (CAM-I). Burleson, TX, 1992

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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. M. Articles by Sandler, A. B. Search for Related Content PubMed Articles by Dilts, D. M. Articles by Sandler, A. B. Social Bookmarking                            What's this?