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

Centralized Review Process Markedly Expedites Approval of Cancer Clinical Trials

Published: Thursday, November 05, 2009
Last Updated: Thursday, November 05, 2009
Bookmark and Share
CIRB for cancer clinical trials, which was created by the National Cancer Institute, expedites the time from concept to completion of crucial investigational research.

A Central Institutional Review Board (CIRB) for cancer clinical trials that was created by the National Cancer Institute (NCI), part of the National Institutes of Health, in 2001 helps trials start quickly and thus expedite the time from concept to completion of crucial investigational research according to a new finding.

This study of the CIRB was performed by scientists at the Veterans Affairs Palo Alto Health Care System (VAPAHCS) and Stanford University School of Medicine, Palo Alto, Calif., with assistance from NCI and appears online October 19, 2009 in the Journal of Clinical Oncology.

Over the past 40 years, more than 1,700 institutions in the United States have enrolled up to 20,000 patients annually in phase III clinical trials coordinated by NCI and have used separate IRBs to monitor research involving patients. Federal regulations require that most NIH-funded clinical trials be monitored by an IRB.

To determine whether a new treatment is safe and more effective than current treatments using clinical trials is a lengthy process that can take up to 10 years and cost more than $1 billion, in some cases. Many researchers have complained that administrative requirements, including IRB oversight, are delaying the release of new treatments. One solution NCI proposed was to form a CIRB to conduct IRB review of large, multi-site oncology trials.

"Mounting a CIRB that is nationwide in scope has been challenging for NCI due to the complexity involved in assuring high-quality protection for study participants while attempting to speed the process," said Jeffrey Abrams, M.D., associate director of NCI's Cancer Therapy Evaluation Program. "For all the volunteer reviewers and participating sites, this study provides objective confirmation that a centralized approach significantly improves the overall process for participants in multi-site trials."

The study assessed whether use of NCI's CIRB was associated with lower effort, time and cost in processing adult phase III oncology trials, which are the gold-standard of trials for validating whether a therapy becomes a new standard of care. Early phase trials (phase I and II) and pediatric trials were not included in the analysis due to the lower patient enrollment populations required.

Clinical trial sites that are not enrolled with the CIRB must have their local IRB conduct a full board review as they would with any research study. Sites enrolled with the CIRB have their local IRB conduct a facilitated review, which is a review category requiring only that the local IRB chairperson or designee signal acceptance of the CIRB's review.

To determine whether the CIRB was achieving the hoped-for efficiencies, researchers compared clinical trial review at sites affiliated with the NCI CIRB with the review at unaffiliated sites that used their local IRB. Oncology research staff and IRB staff were surveyed to understand differences in effort, timing and costs of clinical trial review.

CIRB affiliation was associated with faster local review (about 34 days) and about six hours less research staff effort. Many clinical trials sponsors value faster and more predictable reviews and often pay commercial, fee- for-service, central IRBs to perform reviews.

Affiliation with NCI's CIRB was also associated with a savings of $717 per initial review, of which about half was associated with time savings for research staff and the remainder was associated with savings for the IRB staff. Overall, the program resulted in a net cost of $55,000 per month for NCI, but the CIRB could actually save costs if more sites were to use the CIRB. Moreover, this net cost estimate does not include the benefits of bringing new cancer therapeutics to market quickly.

"Efforts are underway to expand enrollment in the CIRB and to encourage sites to use the CIRB to minimize administrative inefficiencies," said lead researcher Todd H. Wagner, Ph.D., health economist, VAPAHCS and Stanford University School of Medicine, Palo Alto, Calif., "and based on our research, increased efficiencies and net savings are likely."


Further Information

Join For Free

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 3,900+ scientific posters on ePosters
  • More Than 5,300+ 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

Using Cancer Cells' Mass to Predict Treatment Response
A device has been developed that can detect changes in cell mass at a minute scale.
Thursday, November 24, 2016
NCI Collaborates with Multiple Myeloma Research Foundation
NCI collaborates with MMRF to incorporate genomic and clinical data into NCI Genomic Data Commons database.
Thursday, September 29, 2016
CES Score May Predict Response to Cancer Treatment
Researchers identify new type of biomarker that helps predict prognosis and response to several types of cancer treatment.
Tuesday, September 27, 2016
Forging Collaborations to Progress Against Cancer
NCI take steps to further international collaborations to expand cancer research.
Monday, September 26, 2016
Stem Cell Transplant Without Radiation or Chemotherapy
Researchers have successfully performed stem cell transplants without using radiation or chemotherapy.
Friday, September 09, 2016
NCI Embraces Recommendations for Cancer Moonshot
NCI accepts recommendations for approaches likely to make progress against cancer under the Cancer Moonshot
Thursday, September 08, 2016
Engineered Stem Cells Identify Medulloblastoma Treatment
Researchers have engineered neural stem cells to carry mutations thought to drive a particular subtype of medulloblastoma.
Monday, September 05, 2016
Tumor DNA in Blood Signals Immunotherapy Response
Research suggests that tumor DNA circulating in blood may be a biological marker for T-cell transfer immunotherapy.
Friday, September 02, 2016
Mutations in DNA-Repair Genes Found in Advanced Prostate Cancers
New findings indicate that nearly 12% of male advanced prostate cancer sufferers have inherited mutation in DNA-repair genes.
Wednesday, July 27, 2016
Identifying Cancer Drug Targets Using 3D-Modelling
Researchers are now able to model genetic mutations manipulation of proteins that can potentially drive cancer.
Monday, July 18, 2016
Elevated Bladder Cancer Risk in New England and Arsenic in Drinking Water From Private Wells
Researchers have found that drinking water from private wells, may have contributed to the elevated risk of bladder cancer in northern new England.
Tuesday, May 03, 2016
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
NCI Announces Plans to Reinvigorate Clinical Trials
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.
Friday, December 24, 2010
Scientific News
Big Genetics in BC: The American Society for Human Genetics 2016 Meeting
Themes at this year's meeting ranged from the verification, validation, and sharing of data, to the translation of laboratory findings into actionable clinical results.
Stem Cells in Drug Discovery
Potential Source of Unlimited Human Test Cells, but Roadblocks Remain.
Cancer Genetics: Key to Diagnosis, Therapy
When applied judiciously, cancer genetics directs caregivers to the right drug at the right time, while sparing patients of unnecessary or harmful treatments.
BGI Sequences Gingko Tree, Revealing Large, Highly Repetitive Genome
Researchers at BGI have sequenced the more than 10-gigabase ginkgo genome to find a high number of repetitive sequences as well as a number of gene clusters that appear to be involved in defense mechanisms.
Survey of New York City Soil Uncovers Medicine-Making Microbes
Microbes have long been an invaluable source of new drugs. And to find more, we may have to look no further than the ground beneath our feet.
Accelerating the Detection of Foodborne Bacterial Outbreaks
The speed of diagnosis of foodborne bacterial outbreaks could be improved by a new technique developed by researchers at the Georgia Institute of Technology.
Making Personalized Medicine a Reality
Groundbreaking technique developed at McMaster University is helping to pave the way for advances in personalized medicine.
Scientists Identify Unique Genomic Features in Testicular Cancer
The findings may shed light on factors in other cancers that influence their sensitivity to chemotherapy.
Top 10 Life Science Innovations of 2016
2016 has seen the release of some truly innovative products. To help you digest these developments, The Scientist have listed their top picks for the year.
BioCision Forms MedCision
The new company will focus on technologies for the management and automation of vital clinical processes.
Scroll Up
Scroll Down
Skyscraper Banner

SELECTBIO Market Reports
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
3,900+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
5,300+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FOR FREE!