Corporate Banner
Satellite Banner
Technology
Networks
Scientific Communities
 
Become a Member | Sign in
Home>News>This Article
  News
Return

NCI Announces Plans to Reinvigorate Clinical Trials

Published: Friday, December 24, 2010
Last Updated: Friday, December 24, 2010
Bookmark and Share
The National Cancer Institute (NCI) has announced major changes to be made in the long-established Clinical Trials Cooperative Group Program that conducts many of the nationwide trials of new cancer therapies.

In a major transformation, NCI intends to consolidate the nine groups that currently conduct trials in adult cancer patients into four state-of-the-art entities that will design and perform improved trials of cancer therapies. These changes are designed to provide greater benefits for cancer patients and more information for researchers. These moves come in response to an NCI-requested April 2010 report from the Institute of Medicine (IOM), which called for a series of changes to the cooperative groups program, including restructuring.

"Clinical trials are at the heart of cancer care and treatment, and NCI is dedicated to making sure they are as effective as they can be," said Harold E. Varmus, M.D., NCI director. "In the last decade, our knowledge of genetic and epigenetic changes that drive the initiation and progression of cancers has increased exponentially. Consequently we must assess and improve the methods by which NCI evaluates new therapies that take advantage of our new understanding of many kinds of cancers."

The April IOM report noted that the current trials system is inefficient, cumbersome, underfunded, and overly complex. The report recommended consolidating existing adult cooperative groups into a smaller number of groups that could function in a more closely integrated manner.

The NCI Cooperative Group program, founded over 50 years ago, involves more than 3,100 institutions and 14,000 investigators, and the program enrolls over 25,000 patients in clinical trials each year.  Four pediatric groups were consolidated into one group a number of years ago, and that sole pediatric group will not be consolidated with other groups.

"The practice of oncology has changed significantly with the development of molecular oncology, therefore we need a modern system with modern trials that will maximally utilize the molecular characteristics of a patient's tumor and guide us to the best possible treatment for that patient," said James H. Doroshow, M.D., director, NCI Division of Cancer Treatment and Diagnosis. "This evolution in our understanding of cancer will lead to an evolution in the design and implementation of clinical trials."

For the past several decades, clinical cancer trials have used one or a combination of drugs or other treatment modalities, such as surgery or radiation, in comparison to the prevailing standard of care to see if the new treatment was superior.  Recently, some trials have begun to depend on the genetic profiling of tumors.  For example, one ongoing NCI-sponsored breast cancer study, called TAILORx, is examining whether genes that are frequently associated with risk of recurrence for women with early-stage breast cancer can be used to assign patients to more appropriate and effective treatments.  

These types of studies necessitate the screening of large numbers of patients in order to find subsets of patients with tumors that demonstrate changes in specific genetic pathways. These trials therefore require acquisition and distribution of many tumor specimens, DNA sequencing, and the matching of genetic information with treatment options.  The increased complexity of these trials provides a rationale for modernization and simplification of the current cooperative group structure.

Consolidation is intended to improve the efficiencies of operations centers, data management centers, and tumor banks, and the changes will take into consideration an assessment of all currently active cooperative groups.  The current groups will also be given opportunities to comment on the proposed changes and to explore specific aspects of the reorganization plans in consultation with NCI leadership.

While consolidation of specific groups proceeds, other generalized efficiencies are already being planned, such as shortening the time required to initiate new clinical trials. Historically, when a new study was proposed, the concept had to be submitted for approval in a process that took as long as several years. Furthermore, if this review was not completed within two years after concept approval, a trial was very unlikely to reach its ultimate recruitment goals, in part because the scientific questions underpinning the concept could be overtaken by new developments.  

On Jan. 1, 2011, NCI will impose new deadlines, formulated by its Operational Efficiency Working Group, which will reduce by half the time to initiate new clinical studies and will terminate studies not begun within two years of concept approval.  

NCI has also been working to increase efficiency in several other ways, including:

-- Decreasing the average time for final sign-off and approval on protocols for national trials by its centralized institutional review board from 150 days in 2007, to 42 days in 2010
-- Prioritizing a revamped review process, which will include advocates and professionals at  cancer centers, with new emphasis on disease-specific and modality-specific oversight, such as imaging or cancer control
-- Modernizing information technology so that a single system can collect standardized clinical trial data, such as patient information and outcomes

A list of the current 10 U.S.-based NCI Cooperative Groups can be found here


Further Information
Access to this exclusive content is for Technology Networks Premium members only.

Join Technology Networks Premium for free access to:

  • Exclusive articles
  • Presentations from international conferences
  • Over 2,500+ scientific posters on ePosters
  • More Than 3,700+ scientific videos on LabTube
  • 35 community eNewsletters


Sign In



Forgotten your details? Click Here
If you are not a member you can join here

*Please note: By logging into TechnologyNetworks.com you agree to accept the use of cookies. To find out more about the cookies we use and how to delete them, see our privacy policy.

Related Content

Near-Atomic Resolution of Protein Structure Holds Promise for Drug Discovery
A new study shows that it is possible to use an imaging technique called cryo-electron microscopy to view the architecture of a metabolic enzyme bound to a drug that blocks its activity.
Friday, May 08, 2015
National Cancer Institute Awards Two Lung Cancer CTC Development Contracts to Cynvenio Biosystems, Inc.
Company also announces additional equity investment of $2.0 million.
Tuesday, February 07, 2012
2011 Biospecimen Research Network (BRN) Symposium
The National Cancer Institute's (NCI) Biospecimen Research Network Symposium, "Advancing Cancer Research Through Biospecimen Science," will be held March 28-29, 2011, at the Bethesda North Marriott Hotel & Conference Center in Bethesda, MD
Friday, January 07, 2011
National Cancer Institute Awards Nearly $4M to University of new Mexico Cancer Center
The awards support cancer nanotechnology partnership with Sandia Labs.
Wednesday, November 10, 2010
Scientists Identify Markers on Human Breast Cancer Cells Linked to Development of a Form of Breast Cancer
The scientists named these human cells with tumor-forming ability in mice, xenograft-initiating cells, or XIC.
Friday, May 21, 2010
Expression of Proteins Linked to Poor Outcome in Women with Ovarian Cancer
The study led by NCI scientists may provide targets for the development of novel therapies for ovarian cancer.
Wednesday, April 21, 2010
Antibodies Against Abnormal Glycoproteins Identified as Possible Biomarkers for Cancer Detection
Scientists have found that cancer patients produce antibodies that target abnormal glycoproteins made by their tumors.
Thursday, February 04, 2010
The Cancer Genome Atlas Identifies Distinct Subtypes of Deadly Brain Cancer
According to study the most common form of malignant brain cancer in adults appears to be four distinct molecular subtypes.
Thursday, January 21, 2010
Diet May Protect Against Gene Changes in Smokers
A new study finds that leafy green vegetables, folate, and multivitamins could serve as protective factors against lung cancer in smokers.
Thursday, January 14, 2010
Gene Mutations Reveal Potential new Targets for Treating a Type of Non-Hodgkin's Lymphoma
Findings provide insight into a mechanism that cancer cells may use to survive.
Tuesday, January 12, 2010
Gene Mutations Reveal Potential new Targets for Treating a Type of Non-Hodgkin's Lymphoma
Findings provide insight into a mechanism that cancer cells may use to survive.
Friday, January 08, 2010
Drug for Multiple Myeloma Demonstrated to Extend Disease-Free Survival
Patients receiving lenalidomide following a blood stem cell transplant had their cancer kept in check longer than placebo receiving patients.
Thursday, December 24, 2009
Gene's Position in the Nucleus Can be Used to Distinguish Cancerous from Normal Breast Tissue
Researchers have identified several genes whose spatial position inside the cell nucleus is altered in invasive breast cancer.
Wednesday, December 09, 2009
Centralized Review Process Markedly Expedites Approval of Cancer Clinical Trials
CIRB for cancer clinical trials, which was created by the National Cancer Institute, expedites the time from concept to completion of crucial investigational research.
Thursday, November 05, 2009
Duplicated Gene May Explain Rare Cancer in Some Families
NCI researchers have now identified a genetic change that may lead to chordoma, a type of bone cancer, in four of the families.
Monday, October 26, 2009
Scientific News
The Changing Tides of the In Vitro Diagnostics Market
With the increasing focus in personalized medicine, diagnostics plays a crucial role in patient monitoring.
LaVision BioTec Reports on the Neuro Research on the Human Brain After Trauma
Company reports on the work of Dr Ali Ertürk from the Institute for Stroke and Dementia Research at LMU Munich.
NIH Study Shows No Benefit of Omega-3 Supplements for Cognitive Decline
Research was published in the Journal of the American Medical Association.
Less May Be More in Slowing Cholera Epidemics
Mathematical model shows more cases may be prevented and more lives saved when using one dose of cholera vaccine instead of recommended two doses.
Investigating the Vape
Expert independent review concludes that e-cigarettes have potential to help smokers quit.
NIH Launches Human RSV Study
Study aims to understand infection in healthy adults to aid development of RSV medicines, vaccines.
Researchers Discover Synthesis of a New Nanomaterial
Interdisciplinary team creates biocomposite for first time using physiological conditions.
Poor Survival Rates in Leukemia Linked to Persistent Genetic Mutations
For patients with an often-deadly form of leukemia, new research suggests that lingering cancer-related mutations – detected after initial treatment with chemotherapy – are associated with an increased risk of relapse and poor survival.
Flu Remedies Help Combat E. coli Bacteria
Physiologists from the University of Zurich have now discovered why the intestinal bacterium Escherichia coli (E. coli) multiplies heavily and has an inflammatory effect.
Marijuana Genome Unraveled
A study by Canadian researchers is providing a clearer picture of the evolutionary history and genetic organization of cannabis, a step that could have agricultural, medical and legal implications for this valuable crop.
Scroll Up
Scroll Down
Skyscraper Banner

Skyscraper Banner
Go to LabTube
Go to eposters
 
Access to the latest scientific news
Exclusive articles
Upload and share your posters on ePosters
Latest presentations and webinars
View a library of 1,800+ scientific and medical posters
2,500+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
3,700+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FREE!