|
Advertisement |
|
|
||
 |
|
|||||
|
|||||
|
 |
||||||
|
||||||
|
||||||
|
Journal of Clinical Oncology, Vol 25, No 9 (March 20), 2007: pp. 1148 © 2007 American Society of Clinical Oncology. DOI: 10.1200/JCO.2006.09.5232
Processes to Activate Phase III Clinical Trials in a Cooperative Oncology Group: The Elephant Is MonstrousMayo Clinic, Rochester, MN To the Editor: There is a worn cliché about an elephant huddling in the corner of a room that everyone inside is afraid to talk about. In the case of the Byzantine complexity and geological time scales involved in opening clinical trials in the cooperative oncology group setting, the elephant is much spoken of by frustrated investigators (often accompanied by strong oaths), but there has been little agreement about just how big and brutal this creature actually is. Dilts and colleagues in the Cancer and Leukemia Group B are to be congratulated for finally providing a detailed sketch1 of the beast, revealing that it is more akin to J.R.R. Tolkien's monstrous war Oliphaunts2 than to the friendly peanut-loving pachyderm at the local zoo. It seems likely that an investigation of other cooperative groups would yield similar results because many of the processes (especially external review loops) are common. Even though it is hard to imagine that a 20-foot by 3.5-foot process map printed in 8-point font could depict an overly rosy view of matters, I wonder if this is actually the case. The Cancer and Leukemia Group B investigators reviewed only the 13 clinical trials that were actually activated over a 3-year period between May 2002 and May 2005. How many trials were never activated (despite approval of the concept) because one of the 29 process loops became infinite, or one of the 42 decision points resulted in a choice to finally hoist the white flag and give up? More difficult to measure are the studies that did eventually activate, but accrued more poorly than expected because the study had taken so many years to come to fruition that the clinical question asked was no longer as relevant or interesting to enrolling physicians as it once seemed all those years before. In addition, it is simply impossible to know how many good concepts investigators elect not to bother moving forward because the prospect of clearing 370 distinct hurdles before the study even opens is simply too daunting—not to mention the stacks of often-meaningless serious adverse event forms and other bureaucratic paperwork that dog well-meaning investigators long after the study finally activates. Last week, for instance, I found myself signing a stack of empty sheets of paper for a clinical trial, signifying adverse events that did not occur—dogs that did not bark in the night, or the medical equivalent of the publisher's "This Page Intentionally Left Blank"—which seemed rather a poor use of a lengthy postgraduate education. The system has clearly gone amok. It is perhaps too much to ask that a process that has so many powerful and bureaucratically entrenched stakeholders (National Cancer Institute, US Food and Drug Administration, Cancer Therapy Evaluation Program, Institutional Review Boards, billion-dollar drug companies, huge academic medical centers with overworked protocol development teams, and investigators who may disagree on the concept or may simply be egotistical) would be simple and straightforward. Still, the report of Dilts and colleagues simply cries out for urgent, systematic reform. Those of us who see needy patients and know that an applicable protocol is in development grow particularly frustrated by the dithering of those in remote offices who have no real sense of the urgency and desperation in the consultation room—and imagine how patients would feel lining up the Kaplan-Meier survival curve for their particular disease against the level 0 flow map for a clinical trial going through a cooperative group. It might take an act of Congress to close some of the external agency loops and eliminate the catch-22 stonewalling (and I shudder to think of what the process map would look like for such a bill before the national government), but as Dilts and colleagues have now so clearly pointed out, the need is overwhelming. AUTHOR'S DISCLOSURES OF POTENTIAL CONFLICTS OF INTEREST The author indicated no potential conflicts of interest. REFERENCES 1. Dilts DM, Sandler AB, Baker M, et al: Process to activate phase III clinical trials in a cooperative oncology group: The case of cancer and Leukemia Group B. J Clin Oncol 28:4553-4557, 2006 2. Tolkien JRR: The Lord of the Rings: The Two Towers. London, England, Allen & Unwin, 1952, Chapter 3
Related Reply
Related Article
This article has been cited by other articles:
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|
|||||||||||
|
|||||||||||
|
|
Copyright © 2007 by the American Society of Clinical Oncology, Online ISSN: 1527-7755. Print ISSN: 0732-183X
|
