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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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