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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25.12.2012 Views

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 As contributors to the goal of eliminating suffering and death due to cancer, DCTD staff members and their colleagues are reexamining discovery, development, and delivery of cancer therapeutics. What follows is a brief summation of some of the division’s priorities as it hastens to find and develop more interventions tailored to the specific characteristics of a patient’s cancer. Restructuring NCI–Supported Clinical Trials Between January 2004 and June 2005, the Clinical Trials Working Group (CTWG), a panel of 38 clinical trialists, advocates, and government representatives, conducted a transparent, inclusive evaluation of the cancer clinical trials process. The aim of the assessment was to improve efficiency, decrease redundancy and administrative burdens, and better coordinate activities to enhance the development and delivery of the best therapies to people with cancer. The CTWG’s five-year improvement plan was approved for implementation by the National Cancer Advisory Board (NCAB) in June 2005. Dr. James Doroshow, DCTD director and CTWG chair, has begun the process of executing the CTWG recommendations. A full six months ahead of schedule, a new NCI organizational structure, designed to oversee the Institute’s entire clinical trials enterprise, was unveiled at the NCAB February 2006 meeting. The structural components of the reorganization are the Clinical Trials Advisory Committee (CTAC), the Clinical Trials Operations Committee (CTOC), and the Coordinating Center for Clinical Trials (CCCT). CTAC, the first new NCI advisory committee to the director approved in the past decade, will advise the NCI director on the Institute’s clinical trials program and will include members of the NCAB as well as other NCI advisory boards and additional cancer clinical trials experts. CTAC will oversee implementation of CTWG initiatives, including a review of the system to evaluate and measure the effects of the implementation. CTAC also will provide advice on the use of correlative science funds, additional funding allotted to specific clinical trials for correlative science and quality-of-life studies. CTOC, an internal NCI committee chaired by the NCI deputy director for clinical and translational sciences, includes the directors of every NCI division, branch, or center involved in clinical trials. Based in the NCI director’s office, CTOC will coordinate clinical trials programs across NCI and will make recommendations to improve cost-effectiveness and reduce duplication and overlap among NCI components involved in clinical trials. CTOC will also evaluate new Requests for Applications and Program Announcements for clinical trials prior to review by the NCI Executive Committee. CCCT will provide project management for the implementation of all CTWG initiatives. CCCT will support a number of significant activities, including coordinating new 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

disease-specific steering committees for the prioritization of phase III trials, the investigational drug steering committee for phase I and II trials, and working groups that will develop critical new tools for clinical investigators, as well as measures to improve clinical trial operational efficiency. Two disease-specific cancer steering committees have begun to take shape. In January and June 2006, respectively, the steering committees for gastrointestinal cancers and gynecologic malignancies held their first meetings. DCTD Staff Members Add Expertise to the Translational Research Working Group In 2005, following the success of the CTWG, a Translational Research Working Group (TRWG) was established to review NCI’s current intramural and extramural translational research portfolio and to recommend ways to improve and integrate translational research efforts. The ultimate goal is to rapidly translate the scientific discoveries of the cancer community’s many dedicated scientists into new interventions for preventing, diagnosing, and treating cancer. The DCTD director and several associate directors from the division are participating in the TRWG process, which is set to make recommendations in early 2007. 8 ■ P R O G R A M A C C O M P L I S H M E N T S 2 0 0 6 ■ ■ ■ Modern drug development techniques that employ imaging and other advances also make foreseeable the arrival of screening tools that could, early in the pathway, predict therapeutic or toxic activity in humans. Accelerating Cancer Drug Development Despite increases in drug development expenditures in the public and private sectors during the 1990s, the number of new agents reaching human clinical trials has been decreasing. Even when compounds proceed to clinical testing, they often fail because of unexpected toxicities or lack of efficacy. The pathway from discovery of promising agents to delivery in the oncology clinic, though multifaceted and complex, may change due to improvements in our understanding of drug targeting at the molecular level. Modern drug development techniques that employ imaging and other advances also make foreseeable the arrival of screening tools that could, early in the pathway, predict therapeutic or toxic activity in humans. Such changes should shorten the amount of time it takes to bring useful new anticancer drugs to the patients who need them. The following improvements in the use of DCTD resources have been made in the past year to accelerate drug development: ■ DCTD and CCR have established a formal partnership to enhance pre-clinical and clinical drug testing ● A joint pipeline of new agents is now being actively managed by DCTD and CCR - Decisions about what agents to develop are being made by a newly established joint development committee

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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