National Cancer Institute - NCI Division of Cancer Treatment and ...
National Cancer Institute - NCI Division of Cancer Treatment and ...
National Cancer Institute - NCI Division of Cancer Treatment and ...
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<strong>of</strong> cancer. The site also includes links to<br />
other patient information materials.<br />
ClinicalTrials.gov<br />
http://clinicaltrials.gov<br />
This Website provides regularly updated<br />
information about federally <strong>and</strong> privately<br />
supported clinical research in human volunteers.<br />
It includes all diseases <strong>and</strong> gives<br />
information about a trial’s purpose, who<br />
may participate, locations, <strong>and</strong> phone<br />
numbers for more details.<br />
Community Clinical Oncology<br />
Program<br />
http://www.cancer.gov/prevention/ccop<br />
The Community Clinical Oncology Program<br />
(CCOP), administered by the <strong>NCI</strong><br />
<strong>Division</strong> <strong>of</strong> <strong>Cancer</strong> Prevention, is a comprehensive<br />
clinical trial mechanism for<br />
disseminating the latest cancer prevention<br />
<strong>and</strong> treatment research findings to the<br />
community level. A third <strong>of</strong> all patients<br />
accrued to all <strong>NCI</strong> treatment trials <strong>and</strong> prevention<br />
trials are enrolled at CCOP sites.<br />
Created in 1983, the program works in<br />
t<strong>and</strong>em with CTEP to enable patients <strong>and</strong><br />
physicians to participate in clinical trials at<br />
61 major research centers in 34 states, the<br />
District <strong>of</strong> Columbia, <strong>and</strong> Puerto Rico.<br />
In 2005, 50 CCOPs <strong>and</strong> 13 minority-based<br />
CCOPs across the country received funding<br />
for participation in <strong>NCI</strong>-approved trials.<br />
Altogether, the program comprises 3645<br />
participating physicians <strong>and</strong> 415 participating<br />
hospitals working on more than<br />
300 active treatment trials <strong>and</strong> more than<br />
70 active prevention <strong>and</strong> control trials.<br />
CTEP’s Online Resources<br />
for Investigators<br />
http://ctep.cancer.gov/resources/<br />
index.html<br />
CTEP <strong>of</strong>fers investigators online resources<br />
for submitting data <strong>and</strong> reports, conducting<br />
research, <strong>and</strong> accessing reference<br />
materials:<br />
■ Investigators’ H<strong>and</strong>book (http://ctep.<br />
cancer.gov/h<strong>and</strong>book/index.html):<br />
Offers practical information for oncologists,<br />
nurses, pharmacists, research<br />
administrators, <strong>and</strong> data managers<br />
about policies <strong>and</strong> procedures <strong>of</strong> DCTD<br />
with respect to the clinical use <strong>of</strong> its<br />
investigational agents, as well as<br />
guidance on protocol writing <strong>and</strong><br />
submissions, reporting requirements,<br />
<strong>and</strong> agent accountability<br />
■ Common Terminology Criteria for Adverse<br />
Events (CTCAE) v2.0 <strong>and</strong> v3.0: St<strong>and</strong>ards<br />
used to grade, assign attribution, <strong>and</strong><br />
report adverse effects experienced by<br />
patients in clinical trials<br />
■ Adverse Event Expedited Reporting System<br />
(AdEERS): <strong>NCI</strong>’s Web-based system for<br />
submitting expedited reports for serious<br />
or unexpected events that occur during<br />
a clinical trial<br />
■ Common Data Elements (CDE) Dictionary:<br />
A dictionary <strong>of</strong> terms that are used<br />
when collecting patient information for<br />
clinical trials or cancer care<br />
■ Clinical Data Update System (CDUS):<br />
The mechanism used when submitting<br />
specified data for CTEP-approved<br />
clinical trials<br />
C A N C E R T H E R A P Y E V A L U A T I O N P R O G R A M ■ 93