Department of Defense Prostate Cancer Clinical Trials Consortium: A New Instrument for Prostate Cancer Clinical Research

被引：21

作者：

Morris, Michael J. ^{[1
,2
]}

Basch, Ethan M. ^{[1
,2
]}

Wilding, George ^{[3
]}

Hussain, Maha ^{[4
,5
]}

Carducci, Michael A. ^{[6
]}

Higano, Celestia ^{[7
,8
]}

Kantoff, Philip ^{[9
,10
]}

Oh, William K. ^{[9
,10
]}

Small, Eric J. ^{[11
]}

George, Daniel ^{[12
]}

Mathew, Paul ^{[13
]}

Beer, Tomaz M. ^{[14
]}

Slovin, Susan F. ^{[1
,2
]}

Ryan, Charles ^{[11
]}

Logothetis, Christopher ^{[13
]}

Scher, Howard I. ^{[1
,2
]}

机构：

[1] Mem Sloan Kettering Canc Ctr, Genitourinary Oncol Serv, New York, NY 10065 USA

[2] Cornell Univ, Dept Med, Joan & Sanford E Weill Coll Med, New York, NY 10021 USA

[3] Univ Wisconsin, Carbone Comprehens Canc Ctr, Madison, WI USA

[4] Univ Michigan, Dept Internal Med, Ann Arbor, MI 48109 USA

[5] Univ Michigan, Dept Urol, Ann Arbor, MI 48109 USA

[6] Sidney Kimmel Comprehens Canc Ctr Johns Hopkins, Baltimore, MD USA

[7] Univ Washington, Dept Med, Seattle, WA USA

[8] Univ Washington, Dept Urol, Seattle, WA 98195 USA

[9] Dana Farber Harvard Canc Ctr, Boston, MA USA

[10] Harvard Univ, Sch Med, Boston, MA USA

[11] Univ Calif San Francisco, UCSF Canc Ctr, San Francisco, CA 94143 USA

[12] Duke Univ, Dept Surg, Duke Comprehens Canc Ctr, Div Urol, Durham, NC USA

[13] Univ Texas MD Anderson Canc Ctr, Houston, TX 77030 USA

[14] Oregon Hlth & Sci Univ, OHSU Canc Inst, Portland, OR 97201 USA

来源：

CLINICAL GENITOURINARY CANCER | 2009年 / 7卷 / 01期

关键词：

Clinical consortium; Collaborative; Infrastructure; Phase I/II trial; END-POINTS; RECOMMENDATIONS; ELIGIBILITY;

D O I：

10.3816/CGC.2009.n.009

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

Background: In 2005, the US Department of Defense, through the US Army Medical Research and Materiel Command, Office of the Congressionally Directed Medical Research Programs, created a funding mechanism to form a clinical trials consortium to conduct phase I and II studies in prostate cancer. This is the first report of the Prostate Cancer Clinical Trials Consortium (PCCTC). Patients and Methods: The Department of Defense award supports a consortium of 10 prostate cancer research centers. Memorial Sloan-Kettering Cancer Center was awarded the Coordinating Center grant for the consortium and charged with creating an infrastructure to conduct early-phase multicenter clinical trials. Each participating center was required to introduce >= 1 clinical trial per year and maintain accrual of a minimum of 35 patients per year. Results: The PCCTC was launched in 2006 and now encompasses 10 leading prostate cancer research centers. Fifty-one trials have been opened, and 1386 patients have been accrued at member sites. Members share an online clinical trial management system for protocol tracking, electronic data capture, and data storage. A legal framework has been instituted, and standard operating procedures, an administrative structure, editorial support, centralized budgeting, and mechanisms for scientific review are established. Conclusion: The PCCTC fulfills a congressional directive to create a clinical trials instrument dedicated to early-phase prostate cancer studies. The member institutions have built an administrative, informatics, legal, financial, statistical, and scientific infrastructure to support this endeavor. Clinical trials are open and accruing in excess of federally mandated goals.

引用

页码：51 / 57

页数：7

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