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 ...
Cancer clinical research is changing, and a large part of the transformation is being spearheaded by the Division of Cancer Treatment and Diagnosis (DCTD), an extramural component of the National Cancer Institute (NCI) with the responsibility of overseeing much of NCI’s infrastructure for clinical trials and drug development. I am pleased to provide you with this summary of accomplishments made possible by the many talented and dedicated staff members in programs throughout the division. Advances in molecular medicine have created new challenges for the design and conduct of cancer clinical trials. The National Cancer Advisory Board’s Clinical Trials Working Group (CTWG) examined these challenges and, last year, issued 22 strategic initiatives to restructure the conduct of NCI-supported clinical trials so that new treatments reach patients with cancer more quickly. The CTWG endorsed team science in the broadest sense. This included the development of mechanisms to enhance the coordination of clinical, basic, and translational scientists in their efforts to improve molecular diagnostic and imaging techniques, as well as to increase the utility of novel targeted therapies. The success of the CTWG initiatives will require a significant commitment by all stakeholders in the clinical trials process to assist NCI in setting new policies, procedures, and standards and in guiding prioritization and decision-making. DCTD will play a leading role in the implementation of the CTWG initiatives, with the goal of producing an integrated, F O R E W O R D Dr. James H. Doroshow, Director, NCI Division of Cancer Treatment and Diagnosis. responsive, efficient, and innovative clinical trials enterprise. The division will also assist the newly created NCI Coordinating Center for Clinical Trials as it assumes the day-to-day responsibilities for project management of the CTWG initiatives. As part of the change process, DCTD and the Center for Cancer Research (CCR) are working in close collaboration to reinvigorate cancer drug development at NCI. Through a new, joint early therapeutics development program, extramural and intramural teams have prioritized a pipeline of NCI-driven targeted therapeutics for development. This program combines the strengths of DCTD’s extensive expertise in anticancer drug development with CCR’s dynamic in-house research and its location within new state-of-theart facilities at the NIH Clinical Research Center. This collaboration will also utilize a recent guidance from the U.S. Food and Drug Administration concerning exploratory studies of investigational new drugs. F O R E W O R D ■ iii
Clinical trials performed using an exploratory investigational new drug (IND) will facilitate targeted therapies entering early phase evaluation where the target can be carefully monitored. The goal of this new guidance is to safely shorten the timeline for drug development. As part of the DCTD-CCR collaboration, novel agents for high-priority targets originating from academic and other extramural researchers will be eligible to take advantage of intramural resources. Exploratory IND studies are ideal, as well, for imaging and other advanced technology applications aimed at developing clinically relevant assays of biomarkers that could help predict whether later-stage trials are likely to be successful. Biomarker assays can also assess the efficacy, mechanism of action, and toxicity of promising treatments. DCTD is also improving its capabilities to develop and validate pharmacodynamic markers. The division is developing standardized operating procedures for handling human tissue specimens and for pharmacodynamic assays. One major goal of this program is to incorporate molecular imaging techniques routinely into early therapeutics development; in particular, there will be a special emphasis on the development of novel imaging probes for monitoring new drug targeting to tumors and for determining the therapeutic benefit of the targeted therapy. The goal is to produce a diverse portfolio of pharmacodynamic assays and imaging iv ■ 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 ■ ■ ■ The implementation of CTWG initiatives, modernization and integration of cancer therapeutics development, and expansion of the pipeline of potential cancer therapies underscore NCI’s position as a premier developer of novel cancer therapeutics and diagnostics. tools that are in the public domain. These complex tasks are time-consuming and expensive, and NCI is well suited to take on this enterprise. It is anticipated that this investment will reap many benefits by making a library of new molecular tools available to all researchers in the cancer research community to assess new targeted drugs and diagnostics. These efforts also support an NCI-wide priority to better integrate preclinical and clinical research. In addition to partnering with intramural researchers in CCR, DCTD is working to link preclinical and clinical resources seamlessly within the division. This will support extramural trials of targeted therapies and foster better assimilation of molecular imaging and radiation techniques into therapeutics development. Teams of experts across NCI will unite to form integrated drug development teams. A joint CCR-DCTD drug development committee will oversee these teams, determine resource priorities, assess agent progress, identify gaps in the portfolio particularly suited to NCI drug development efforts, and evaluate new compounds for inclusion in the pipeline. The steps being taken to implement the CTWG initiatives, modernize and integrate cancer therapeutics development using the exploratory IND and other approaches, and expand the pipeline of potential cancer therapies underscore NCI’s position as a premier developer of novel cancer therapeutics and diagnostics.
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<strong>Cancer</strong> clinical research is<br />
changing, <strong>and</strong> a large part <strong>of</strong><br />
the transformation is being<br />
spearheaded by the <strong>Division</strong> <strong>of</strong> <strong>Cancer</strong><br />
<strong>Treatment</strong> <strong>and</strong> Diagnosis (DCTD),<br />
an extramural component <strong>of</strong> the<br />
<strong>National</strong> <strong>Cancer</strong> <strong>Institute</strong> (<strong>NCI</strong>) with<br />
the responsibility <strong>of</strong> overseeing much <strong>of</strong><br />
<strong>NCI</strong>’s infrastructure for clinical trials <strong>and</strong><br />
drug development. I am pleased to provide<br />
you with this summary <strong>of</strong> accomplishments<br />
made possible by the many talented <strong>and</strong><br />
dedicated staff members in programs<br />
throughout the division.<br />
Advances in molecular medicine have<br />
created new challenges for the design<br />
<strong>and</strong> conduct <strong>of</strong> cancer clinical trials. The<br />
<strong>National</strong> <strong>Cancer</strong> Advisory Board’s Clinical<br />
Trials Working Group (CTWG) examined<br />
these challenges <strong>and</strong>, last year, issued<br />
22 strategic initiatives to restructure the<br />
conduct <strong>of</strong> <strong>NCI</strong>-supported clinical trials so<br />
that new treatments reach patients with<br />
cancer more quickly. The CTWG endorsed<br />
team science in the broadest sense. This<br />
included the development <strong>of</strong> mechanisms<br />
to enhance the coordination <strong>of</strong> clinical,<br />
basic, <strong>and</strong> translational scientists in their<br />
efforts to improve molecular diagnostic<br />
<strong>and</strong> imaging techniques, as well as to<br />
increase the utility <strong>of</strong> novel targeted therapies.<br />
The success <strong>of</strong> the CTWG initiatives<br />
will require a significant commitment by<br />
all stakeholders in the clinical trials process<br />
to assist <strong>NCI</strong> in setting new policies,<br />
procedures, <strong>and</strong> st<strong>and</strong>ards <strong>and</strong> in guiding<br />
prioritization <strong>and</strong> decision-making.<br />
DCTD will play a leading role in the<br />
implementation <strong>of</strong> the CTWG initiatives,<br />
with the goal <strong>of</strong> producing an integrated,<br />
F O R E W O R D<br />
Dr. James H. Doroshow, Director, <strong>NCI</strong> <strong>Division</strong><br />
<strong>of</strong> <strong>Cancer</strong> <strong>Treatment</strong> <strong>and</strong> Diagnosis.<br />
responsive, efficient, <strong>and</strong> innovative clinical<br />
trials enterprise. The division will also<br />
assist the newly created <strong>NCI</strong> Coordinating<br />
Center for Clinical Trials as it assumes<br />
the day-to-day responsibilities for project<br />
management <strong>of</strong> the CTWG initiatives.<br />
As part <strong>of</strong> the change process, DCTD<br />
<strong>and</strong> the Center for <strong>Cancer</strong> Research<br />
(CCR) are working in close collaboration<br />
to reinvigorate cancer drug development<br />
at <strong>NCI</strong>. Through a new, joint early therapeutics<br />
development program, extramural<br />
<strong>and</strong> intramural teams have prioritized a<br />
pipeline <strong>of</strong> <strong>NCI</strong>-driven targeted therapeutics<br />
for development. This program combines<br />
the strengths <strong>of</strong> DCTD’s extensive<br />
expertise in anticancer drug development<br />
with CCR’s dynamic in-house research<br />
<strong>and</strong> its location within new state-<strong>of</strong>-theart<br />
facilities at the NIH Clinical Research<br />
Center. This collaboration will also utilize<br />
a recent guidance from the U.S. Food <strong>and</strong><br />
Drug Administration concerning exploratory<br />
studies <strong>of</strong> investigational new drugs.<br />
F O R E W O R D ■ iii
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