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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

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