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M A J O R O N G O I N G I N I T I AT I V E S A N D A C C O M P L I S H M E N T S<br />

As contributors to the goal <strong>of</strong> eliminating<br />

suffering <strong>and</strong> death due to cancer, DCTD<br />

staff members <strong>and</strong> their colleagues are<br />

reexamining discovery, development,<br />

<strong>and</strong> delivery <strong>of</strong> cancer therapeutics. What<br />

follows is a brief summation <strong>of</strong> some <strong>of</strong><br />

the division’s priorities as it hastens to<br />

find <strong>and</strong> develop more interventions<br />

tailored to the specific characteristics<br />

<strong>of</strong> a patient’s cancer.<br />

Restructuring <strong>NCI</strong>–Supported<br />

Clinical Trials<br />

Between January 2004 <strong>and</strong> June 2005, the<br />

Clinical Trials Working Group (CTWG), a<br />

panel <strong>of</strong> 38 clinical trialists, advocates, <strong>and</strong><br />

government representatives, conducted<br />

a transparent, inclusive evaluation <strong>of</strong> the<br />

cancer clinical trials process. The aim <strong>of</strong><br />

the assessment was to improve efficiency,<br />

decrease redundancy <strong>and</strong> administrative<br />

burdens, <strong>and</strong> better coordinate activities<br />

to enhance the development <strong>and</strong> delivery<br />

<strong>of</strong> the best therapies to people with cancer.<br />

The CTWG’s five-year improvement<br />

plan was approved for implementation<br />

by the <strong>National</strong> <strong>Cancer</strong> Advisory Board<br />

(NCAB) in June 2005. Dr. James Doroshow,<br />

DCTD director <strong>and</strong> CTWG chair, has<br />

begun the process <strong>of</strong> executing the<br />

CTWG recommendations.<br />

A full six months ahead <strong>of</strong> schedule,<br />

a new <strong>NCI</strong> organizational structure,<br />

designed to oversee the <strong>Institute</strong>’s entire<br />

clinical trials enterprise, was unveiled at<br />

the NCAB February 2006 meeting.<br />

The structural components <strong>of</strong> the reorganization<br />

are the Clinical Trials Advisory<br />

Committee (CTAC), the Clinical Trials<br />

Operations Committee (CTOC), <strong>and</strong> the<br />

Coordinating Center for Clinical Trials<br />

(CCCT).<br />

CTAC, the first new <strong>NCI</strong> advisory committee<br />

to the director approved in the past<br />

decade, will advise the <strong>NCI</strong> director on the<br />

<strong>Institute</strong>’s clinical trials program <strong>and</strong> will<br />

include members <strong>of</strong> the NCAB as well as<br />

other <strong>NCI</strong> advisory boards <strong>and</strong> additional<br />

cancer clinical trials experts. CTAC will<br />

oversee implementation <strong>of</strong> CTWG initiatives,<br />

including a review <strong>of</strong> the system to<br />

evaluate <strong>and</strong> measure the effects <strong>of</strong> the<br />

implementation. CTAC also will provide<br />

advice on the use <strong>of</strong> correlative science<br />

funds, additional funding allotted to<br />

specific clinical trials for correlative<br />

science <strong>and</strong> quality-<strong>of</strong>-life studies.<br />

CTOC, an internal <strong>NCI</strong> committee chaired<br />

by the <strong>NCI</strong> deputy director for clinical<br />

<strong>and</strong> translational sciences, includes the<br />

directors <strong>of</strong> every <strong>NCI</strong> division, branch, or<br />

center involved in clinical trials. Based in<br />

the <strong>NCI</strong> director’s <strong>of</strong>fice, CTOC will coordinate<br />

clinical trials programs across <strong>NCI</strong><br />

<strong>and</strong> will make recommendations to<br />

improve cost-effectiveness <strong>and</strong> reduce<br />

duplication <strong>and</strong> overlap among <strong>NCI</strong><br />

components involved in clinical trials.<br />

CTOC will also evaluate new Requests<br />

for Applications <strong>and</strong> Program Announcements<br />

for clinical trials prior to review by<br />

the <strong>NCI</strong> Executive Committee.<br />

CCCT will provide project management for<br />

the implementation <strong>of</strong> all CTWG initiatives.<br />

CCCT will support a number <strong>of</strong> significant<br />

activities, including coordinating new<br />

D I V I S I O N O F C A N C E R T R E A T M E N T A N D D I A G N O S I S ■ 7

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