CLINICAL TRIALS
Patients at NCCCP pilot sites 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
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)
A fotonovela-style introductory Spanish-language presentation that takes you on the journey of José, 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.
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.
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 participación en los estudios clínicos: Lo que los pacientes de cáncer deben saber
This is the Spanish-language version of Taking Part in Clinical Trials: What Cancer Patients Need to Know.
La participación en los estudios clínicos: Estudios para la prevención del cáncer
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 cáncer...Lo que debería saber sobre estudios clínicos
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.
