Department of Defense prostate cancer clinical trials consortium: a new instrument for prostate cancer clinical research.
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).


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 >or=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.


CONCLUSIONS
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.
Morris
Michael J
MJ
Genitourinary Oncology Service, Memorial Sloan-Kettering Cancer Center, New York, NY 10065, USA.
Basch
Ethan M
EM
Wilding
George
G
Hussain
Maha
M
Carducci
Michael A
MA
Higano
Celestia
C
Kantoff
Philip
P
Oh
William K
WK
Small
Eric J
EJ
George
Daniel
D
Mathew
Paul
P
Beer
Tomasz M
TM
Slovin
Susan F
SF
Ryan
Charles
C
Logothetis
Christopher
C
Scher
Howard I
HI
D035843:Biomedical Research / Q000191:economics / Q000639:trends*; D002986:Clinical Trials as Topic; D006077:Government Agencies; D006801:Humans; D008297:Male; D008889:Military Personnel; D009369:Neoplasms / Q000628:therapy*; D011471:Prostatic Neoplasms / Q000517:prevention & control*; D012109:Research Support as Topic; D014481:United States