The Ordinary Miracle of Cancer Clinical Trials
2009; Lippincott Williams & Wilkins; Volume: 27; Issue: 11 Linguagem: Inglês
10.1200/jco.2008.20.6292
ISSN1527-7755
Autores Tópico(s)Cancer Genomics and Diagnostics
ResumoIsn't it remarkable that so many clinical trials come to fruition?When one considers all the events, or lack of events, that can induce a newly conceived treatment study to abort during its multiyear preactivation gestation, and all the obstacles that a toddling activated study can stumble over and be unable to get up again-not to mention the endless, mindless bureaucratic tedium that every study team must endure to avoid being labeled as deviant protocol guardians by external auditors-it is a genuine marvel that so many bright ideas reach maturity, making their way into the world of journals and conferences and influencing clinical practice.Each successfully activated and fully accrued cancer clinical trial is not just a biomedical research ordinary miracle (with apologies to singer Sarah McLachlan), it is also a testament to the desperate needs of patients, the dedicated stubbornness of resourceful oncologists, and the enormous financial rewards possible for corporations who bring blockbusters like rituximab or trastuzumab to market-as well as the ability of like-minded human beings to cooperate and accomplish great things, even within a cumbersome and confusing system.Although the brutal development gauntlet that clinical trials undergo could be considered a necessary selection process akin to "nature red in tooth and claw," ensuring survival of only the fittest studies, it may be just as likely that protocols that successfully endure this merciless winnowing are among those attracting the least attention from predators-the least objectionable, least controversial, and least innovative study designs, destined to yield the least exciting results.The tortuous, twisting trail between an investigator's therapeutic brainstorm and the nervous excitement of a podium presentation at the annual meeting of the American Society of Clinical Oncology is arduous enough for straightforward, single-institution studies that involve only one study sponsor. 1 When the proposed study is instead large and complex-and especially when it can only realistically be conducted through one or several of the National Cancer Institute (NCI) -funded cooperative groups-the glorious, long-awaited day of trial activation can begin to seem like a meeting of Procrastinators Anonymous: perpetually postponed.For the last several years, David Dilts (who holds a PhD in management science) and Alan Sandler (an oncologist), codirectors of Vanderbilt University's Center for Management Research in Healthcare (Nashville, TN), have been working to develop a more detailed understanding of the processes currently required to conduct a clinical trial for patients with cancer.Dilts et al 1 first looked at the Vanderbilt-Ingram Cancer Center and its affiliates to understand singleinstitution activation processes more clearly, and then began their study of NCI-funded cooperative groups by assessing the Cancer and Leukemia Group B (CALGB). 2 Disturbingly, but not surprisingly,
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