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CLINICAL TRIALS

Patients at NCCCP community hospitals have access to the very latest cancer prevention and treatment advances through NCI-sponsored clinical trials. Making these trials available locally will likely draw more patients onto clinical trials and enable researchers to build on these findings to develop and evaluate effective prevention and treatment strategies.

The National Cancer Institute (NCI) has developed and supported a number of resources designed to increase public understanding of and support for clinical trials in hopes of increasing clinical trial accrual rates.

For Professionals

Online Training and Information for Sites to Conduct Clinical Trials

NCI's Clinical Trials Portal

Designed as a "one-stop" for information about cancer clinical trials, this Web-based portal provides direct links to a searchable database of 5,000+ clinical trials, recent trial results, and consumer education materials.
http://www.cancer.gov/clinicaltrials

Incorporating Cancer Clinical Trials Into Your Practice

This Web-based course is for healthcare professionals who are new to the clinical trials research process. The course contains practical information for professionals interested in referring patients to clinical trials, or conducting clinical trials, for the first time.
http://cancer.gov/clinicaltrialscourse

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.
http://phrp.nihtraining.com/users/login.php

Cancer Trials Support Unit (CTSU)

The CTSU is a service provided by the NCI to allow members of the NCI-sponsored Cooperative Groups, members of the Community Clinical Oncology Program (CCOP), and CTSU Independent Clinical Research Sites (CICRS) to access any of the NCI-sponsored clinical trials on the CTSU Web site and activate them at their sites.
http://www.ctsu.org/

CTSU e-Course

The e-Course is an online educational program that introduces and explains the CTSU. The e-COURSE was created to provide registered CTSU members and those interested in becoming registered members with a convenient method of learning about participation in NCI-sponsored clinical trials through the CTSU. http://ecourse.ctsu.org/

NCI's Central Institutional Review Board (NCI CIRB)

The NCI CIRB Initiative is designed to help reduce the administrative burden on local IRBs and investigators while continuing a high level of protection for human research participants. A local IRB's use of the CIRB-facilitated review mechanism enables an investigator to enroll patients into adult and pediatric Cooperative Group clinical trials significantly faster than when employing traditional methods of IRB review.
http://www.ncicirb.org/

Clinical Trials Data Monitoring and Reporting

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 NCI for all trials using an NCI-sponsored investigational agent.
http://ctep.cancer.gov/reporting/adeers.html

Common Toxicity Criteria and Common Terminology Criteria for Adverse Events (CTCAE): Standard terminology used to name and to describe the severity (grade) of adverse events that occur in the treatment of cancer.
http://ctep.cancer.gov/reporting/ctc.html

Patient Care Costs and Coverage Issues in Clinical Trials

This Web page consists of multiple links that provide a guide to insurance coverage and clinical trials, a searchable list and map of U.S. states that require health plans to pay for the patient care costs associated with clinical trials, and information about financial assistance organizations to help patients.
http://www.cancer.gov/clinicaltrials/learning/page5

NCI's Clinical Trials Infrastructure and Programs

NCI's Community Clinical Oncology Program

The Community Clinical Oncology Program (CCOP) is a network for conducting cancer prevention and treatment clinical trials by community medical practitioners. This network connects academic centers (Research Bases who design and conduct the trials) with community physicians (CCOP, MB-CCOP) who accrue patients to those trials.
http://dcp.cancer.gov/programs-resources/programs/ccop

CCOP and MBCCOP Research Base Protocols (Cancer Control and Prevention Trials)

Information on active protocols by Research Base located at this site is updated as protocols are approved.
http://prevention.cancer.gov/programs-resources/programs/ccop/resource/protocols

NCI's Cancer Centers Program

NCI-designated Cancer Centers are a major source of discovery of the nature of cancer and of the development of more effective approaches to cancer prevention, diagnosis, and therapy.
http://cancercenters.cancer.gov/

NCI's Clinical Trials Cooperative Group Program

The Clinical Trials Cooperative Group Program is designed to promote and support clinical trials (research studies) of new cancer treatments, explore methods of cancer prevention and early detection, and study quality-of-life and rehabilitation issues.
http://www.cancer.gov/cancertopics/factsheet/NCI/clinical-trials-cooperative-group

Clinical Trials at NIH

The clinical trials conducted by the National Cancer Institute (NCI) on the NIH campus represent the core of the clinical program of the NCI's Center for Cancer Research (CCR). At the CCR, basic and clinical science are seamlessly integrated with a mission to reduce the burden of cancer through exploration, discovery, and the translation of novel approaches into compassionate and effective care for all cancer patients. Our clinical studies are aimed at answering critical questions about a particular disease or disease process and at identifying promising new therapeutic interventions that can then be confirmed in larger studies carried out across the country at cancer centers participating in NCI-supported research.
http://bethesdatrials.cancer.gov/

Education and Outreach Information

NCI has a variety of resources designed for health professionals regarding clinical trials. Some materials of particular note are described below. All materials can be ordered through NCI's Cancer Information Service at 1-800-4-CANCER or accessed directly through the NCI's Clinical Trials Education Series (CTES) Web page.
http://www.cancer.gov/clinicaltrials/learning/clinical-trials-education-series

Print

Cancer Clinical Trials: The Basic Workbook

Cancer Clinical Trials: The In-Depth Program

Cancer Clinical Trials: A Resource Guide for Outreach, Education, and Advocacy

These train-the-trainer workbooks were developed for health care professionals to learn basic and in-depth information about clinical trials as well as how to conduct outreach to communities. The workbooks are divided into chapters covering various clinical trial concepts and exercises to supplement the learning.

CD-ROM

Cancer Clinical Trials Education Series CD

All of the Clinical Trials Education Series materials are available on this CD.

Slide Programs

Cancer Clinical Trials: The Way We Make Progress Against Cancer

Covers the basics about clinical trials-what they are, who takes part, different types of trials, protecting patients' safety, risks and benefits, and where to find trials. (13-slide PowerPoint presentation with talking points)

Cancer Clinical Trials: The Basics

Covers the topics included in "Cancer Clinical Trials: The Way We Make Progress Against Cancer," plus phases of clinical trials, randomization, types of trials, protocols, and barriers to participation. (27-slide PowerPoint presentation with talking points)

Cancer Clinical Trials: In-Depth Information

Covers clinical trials in greater detail than "Cancer Clinical Trials: The Way We Make Progress Against Cancer," and "Cancer Clinical Trials: The Basics." Includes topics such as the drug development and improvement process, phases of clinical trials, types of trials, and protocol development. (31-slide PowerPoint presentation)

La historia de Jos�

A fotonovela-style introductory Spanish-language presentation that takes you on the journey of Jos�, a man who is given the option of enrolling in a prevention clinical trial. The second presentation follows the same story with a female subject. For general audiences who are not familiar with clinical trials.

La historia de Ana

A fotonovela-style introductory Spanish-language presentation that takes you on the journey of Ana, a woman who is given the option of enrolling in a treatment clinical trial. The second presentation follows the same story with a male subject. For general audiences who are not familiar with clinical trials.

Conversemos un rato

This Spanish-language slide presentation covers the basics about clinical trials-what they are, who takes part, different types of trials, protecting patients' safety, risks and benefits of trials, where to find trials, and issues of concern to Latino audiences. Appropriate for community leaders and health care providers.

For Patients

NCI provides a number of award-winning publications to increase public understanding of clinical trials and their importance. Some materials of particular note are described below. All materials can be accessed directly via http://www.cancer.gov or ordered through NCI's Cancer Information Service at 1-800-4-CANCER.

Booklets

Taking Part in Clinical Trials: What Cancer Patients Need to Know

Defines clinical trials, discusses what patients might expect if they participate in a trial, and discusses things to think about when deciding to participate.

If You Want To Find Ways To Prevent Cancer...Learn About Prevention Clinical Trials

Easy-to-read brochure that explains the basics of cancer prevention trials.

Taking Part in Clinical Trials: Cancer Prevention Studies

Provides information about cancer and clinical trials and helps people decide if participating in a chemoprevention trial is right for them.

La participaci�n en los estudios cl�nicos: Lo que los pacientes de c�ncer deben saber

This is the Spanish-language version of Taking Part in Clinical Trials: What Cancer Patients Need to Know.

La participaci�n en los estudios cl�nicos: Estudios para la prevenci�n del c�ncer

This Spanish language version of Taking Part in Clinical Trials: Cancer Prevention Studies provides information about cancer and clinical trials and helps people decide if participating in a chemoprevention trial is right for them.

Si tiene c�ncer...Lo que deber�a saber sobre estudios cl�nicos

This is the Spanish-language version of If You Have Cancer�What You Should Know About Clinical Trials.

If You Have Cancer and Have Medicare... You Should Know About Clinical Trials

Resource for Medicare recipients who have cancer. It provides general information about cancer clinical trials, Medicare coverage, and questions to ask before joining a clinical trial.

Providing Your Tissue for Research: What You Need to Know

This brochure is meant to complement the face-to-face education between clinicians and potential clinical trial participants. It provides a balanced discussion of questions and answers on how tissue specimens are collected and used in research.

Videos

Cancer Trials�Because Lives Depend On It

Discusses prevention and treatment clinical trials to create general awareness about them. (10 minutes, including discussion guide.)

Cancer Clinical Trials: An Introduction for Patients and Their Families

Discusses treatment clinical trials for patients and their families who may be considering participation. (18 minutes, including discussion guide.)

Handbooks

Handbooks that provide information on clinical trials that take place at the NIH campus in Bethesda, MD are available to order and download at http://bethesdatrials.cancer.gov/information-and-resources/printable-materials.asp.

Clinical Trials Patient Handbook

Provides an overview of cancer clinical trials including information on how to find and join a clinical trial.

A Guide to Cancer Clinical Studies

Provides an overview of cancer clinical trials that has been customized to meet the needs and concerns of the African-American community. This guide explains why clinical trials are important, why someone should participate, and the costs of clinical trials.