TY - JOUR
T1 - Department of Defense prostate cancer clinical trials consortium
T2 - A new instrument for prostate cancer clinical research
AU - Morris, Michael J.
AU - Basch, Ethan M.
AU - Wilding, George
AU - Hussain, Maha
AU - Carducci, Michael A.
AU - Higano, Celestia
AU - Kantoff, Philip
AU - Oh, William K.
AU - Small, Eric J.
AU - George, Daniel
AU - Mathew, Paul
AU - Beer, Tomasz M.
AU - Slovin, Susan E.
AU - Ryan, Charles
AU - Logothetis, Christopher
AU - Scher, Howard I.
N1 - Funding Information:
This study is supported by the US Department of Defense Prostate Cancer Research Program and the Prostate Cancer Foundation. The authors wish to thank Mary Warren, MSW; Jake Vinson, MHA; Moshe Kelsen; Elizabeth Brand; and Hope J. Lafferty, MA, ELS, of the PCCTC for their assistance in preparing this manuscript.
PY - 2009
Y1 - 2009
N2 - 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.
AB - 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.
KW - Clinical consortium
KW - Collaborative
KW - Infrastructure
KW - Phase I/II trial
UR - http://www.scopus.com/inward/record.url?scp=65249178420&partnerID=8YFLogxK
U2 - 10.3816/CGC.2009.n.009
DO - 10.3816/CGC.2009.n.009
M3 - Article
C2 - 19213669
AN - SCOPUS:65249178420
SN - 1558-7673
VL - 7
SP - 51
EP - 57
JO - Clinical Genitourinary Cancer
JF - Clinical Genitourinary Cancer
IS - 1
ER -