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Data and Safety Monitoring

List a Trial in NCI's PDQ® Registry

Becoming a Co-Investigator

Starting a New Clinical Trial

Data Collection and Reporting

Participants in Clinical Trials

NIH Clinical Research Network Inventory

Insurance Coverage

Online Training and Education

Bibliographic Databases

General Information

Coordinating Center for Clinical Trials
Seeks to enhance the best of all the components of the NCI-supported clinical trials system to develop a cooperative enterprise built on a strong scientific infrastructure and a broadly engaged coalition of critical stakeholders.

NCI Clinical Trials Working Group
The Clinical Trials Working Group was established in January 2004 by Dr. Andrew von Eschenbach to advise the National Cancer Advisory Board's Clinical Investigations Subcommittee on issues concerning NCI-supported cancer clinical trials.

List of NCI-Designated Cancer Centers
The Cancer Centers Program of the NCI supports major academic and research institutions throughout the United States to sustain broad-based, coordinated, interdisciplinary programs in cancer research.

Community Clinical Oncology Program (CCOP)
CCOP enables patients and physicians to participate in clinical trials at 61 major research centers in 34 states across the country, the District of Columbia, and Puerto Rico.

NCI Community Cancer Centers Program
NCCCP is a three-year pilot program to test the concept of a national network of community cancer centers to expand cancer research and deliver the latest, most advanced cancer care to a greater number of Americans in the communities in which they live.

Cancer Therapy Evaluation Program (CTEP)
CTEP is the program within the Division of Cancer Treatment and Diagnosis that plans, assesses, and coordinates all aspects of clinical trials.

Division of Cancer Prevention Clinical Trials Management
Information for researchers about developing, reporting, and managing NCI-funded cancer prevention clinical trials.

Recommendations for the Safe Handling of Cytotoxic Drugs
A brochure (PDF file) from the National Institutes of Health's Office of Research Services.

Pediatric Brain Tumor Consortium
(Posted: 04/07/1999, Reviewed: 01/30/2006) - The National Cancer Institute (NCI) announced on April 5, 1999, that it had awarded funds for a Pediatric Brain Tumor Consortium, a network of medical centers that will evaluate promising treatments for children with brain malignancies.

Clinical Trials Education Series
The Clinical Trials Education Series is designed for cancer patients, health professionals, and the general public. It consists of 13 different educational materials (books, booklets, slides, videos) that can be ordered separately or viewed online.

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Data and Safety Monitoring

Data and Safety Monitoring Guidelines
(Posted: 04/27/2000, Reviewed: 01/26/2005) - A guide to the formulation of DSM plans for all phases of cancer clinical trials, in accordance with NIH requirements.

Data and Safety Monitoring Example Plans
(Posted: 07/08/2002, Reviewed: 01/26/2005) - Examples of NCI-approved Institutional Data and Safety Monitoring Plans, submitted by NCI-designated Cancer Centers.

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List a Trial in NCI's PDQ® Registry

List Cancer Clinical Trials in NCI's PDQ® Cancer Clinical Trials Registry
Information about the benefits of listing clinical trials in the PDQ registry, plus the steps involved to submit a trial.

PDQ® Clinical Trial Submission Portal
An online portal that enables easy submission of clinical trials for inclusion in NCI's PDQ Cancer Clinical Trials Registry.

PDQ® - NCI's Comprehensive Cancer Database
Full description of the NCI PDQ database.

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Becoming a Co-Investigator

Cancer Trials Support Unit (CTSU)
CTSU is a pilot project sponsored by NCI for the support of a national network of physicians to participate in NCI-sponsored phase III cancer treatment trials.

Special Populations Networks
A network of 18 institutions that create and implement cancer control, prevention, research, and training programs in minority and underserved communities.

Incorporating Cancer Clinical Trials Into Your Practice
A Web-based course for healthcare providers who are interested in becoming clinical trials investigators and incorporating clinical trials into their practice. If you are not already familiar with clinical trials, you may first wish to take the Cancer Clinical Trials Basics course.

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Starting a New Clinical Trial

Developmental Therapeutics Program
As the drug discovery and development arm of NCI, the Developmental Therapeutics Program plans, conducts, and facilitates the development of therapeutic agents for cancer and AIDS.

Rapid Access to Preventive Intervention Development (RAPID) Program
The RAPID Program makes the contract resources from NCI's Division of Cancer Prevention available to academic and academically affiliated investigators for preclinical and early clinical drug development.

Quick-Trials for Novel Cancer Therapies

State of the Science
Meetings usually are designed to encourage participants to discuss obstacles to translating basic research into clinical practice, identify critical questions that are of the highest priority for clinical investigation, and review the implications for design of phase III trials.

Rapid Access to Intervention Development (RAID)
The Rapid Access to Intervention Development (RAID) program facilitates translation to the clinic of novel, scientifically meritorious therapeutic interventions originating in the academic community.

Incorporating Cancer Clinical Trials Into Your Practice
A Web-based course for healthcare providers who are interested in becoming clinical trials investigators and incorporating clinical trials into their practice. If you are not already familiar with clinical trials, you may first wish to take the Cancer Clinical Trials Basics course.

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Data Collection and Reporting

Cancer Data Standards Repository (caDSR) for Common Data Elements
A repository of terms that medical providers may use to collect patient information for clinical trials or for cancer care. NCI hopes to facilitate uniform standards for cancer clinical trials and patient care by assembling and maintaining this information on-line for all interested caregivers.

Clinical Data Update System (CDUS)
Primary data reporting mechanism for all NCI-sponsored clinical trials.

Adverse Event Expedited Reporting System (AdEERS)
NCI's Web-based system for submitting expedited reports for serious and/or unexpected events forwarded to designated recipients and the NCI for all trials using NCI-sponsored investigational agents.

Common Toxicity Criteria and Common Terminology Criteria for Adverse Events
Resources for standard terminology used to name and to describe the severity (grade) of adverse events that occur in the treatment of cancer.

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Participants in Clinical Trials

Protecting Participants in Clinical Trials
(Posted: 08/30/2001, Reviewed: 05/01/2006) - A collection of material about the ways in which clinical trials participants are protected before and during the conduct of a study.

Clinical Research Training for Members of the Research Team at the NIH Clinical Center
This program responds to the federal mandate requiring human subjects protection education for research teams at the NIH Clinical Center.

Certificates of Confidentiality
(Posted: 05/04/2000, Reviewed: 01/26/2005) - Background information and application procedures for researchers.

Clinical Trials: Questions and Answers
(Reviewed: 05/19/2006) - This fact sheet covers types of clinical trials, who sponsors them, how they are conducted, how participants are protected, and who pays for the patient care costs associated with a clinical trial. Includes some questions to ask a health care provider before entering a clinical trial. National Cancer Institute Fact Sheet 2.11

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NIH Clinical Research Network Inventory

Inventory and Evaluation of Clinical Research Networks
An NIH-established resource designed to promote collaboration among clinical researchers and networks by identifying research topic areas and networks currently involved in clinical studies. Profiles of existing clinical research networks are available via a database that is easy to browse or search using key words.

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Insurance Coverage

States That Require Health Plans to Cover Patient Care Costs in Clinical Trials
(Posted: 12/19/2002, Updated: 12/01/2008) - A searchable list and map of U.S. states that require health plans to pay for the patient care costs associated with clinical trials. Key provisions are summarized.

Clinical Trials and Insurance Coverage - A Resource Guide
(Posted: 12/30/1999, Updated: 01/30/2002) - A guide to information about insurance coverage of the patient care costs associated with clinical trials.

Medicare Coverage of Clinical Trials
(Posted: 08/22/2001, Updated: 01/10/2006) - A collection of material about Medicare's policy of covering routine patient care costs associated with clinical trials.

Cost of Clinical Trials
(Posted: 02/09/1999, Reviewed: 11/25/2008) - A collection of material about studies showing that patient care costs for clinical trials are not appreciably higher than costs for patients not enrolled in trials.

Veterans Affairs and Department of Defense Beneficiaries
(Posted: 10/15/1999, Reviewed: 04/14/2008) - A collection of material about an agreement allowing U.S. veterans and Department of Defense TRICARE beneficiaries to participate in NCI-sponsored cancer clinical trials as part of their health benefits.

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Online Training and Education

Protecting Human Research Participants
A free, on-line tutorial offered by the National Institutes of Health (NIH) Office of Extramural Research, for physicians, nurses, and other members of clinical research teams. This online course satisfies the NIH human subjects training requirement for extramural researchers obtaining Federal funds.

Cancer Clinical Trials Basics
A Web-based course for healthcare providers and others who have a limited clinical research background and are somewhat unfamiliar with the clinical trials process.

Incorporating Cancer Clinical Trials Into Your Practice
A Web-based course for healthcare providers who are interested in becoming clinical trials investigators and incorporating clinical trials into their practice. If you are not already familiar with clinical trials, you may first wish to take the Cancer Clinical Trials Basics course.

Clinical Research Training for Members of the Research Team at the NIH Clinical Center
This program responds to the federal mandate requiring human subjects protection education for research teams at the NIH Clinical Center.

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Bibliographic Databases

Cancer Library
Select from NCI's cancer education publications or search the National Library of Medicine's bibliographic database (PubMed).

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