5. Finding Clinical Trials
Organizations that Sponsor Clinical Trials
Finding Information on Cancer and Clinical Trials
Exercises
Cooperative groups, cancer centers, hospitals, and local
physician offices conduct clinical trials. NCI, pharmaceutical
companies, and other groups may fund them. They take place in
diverse locations all over the country.
When locating clinical trials, it is important to remember that
no single resource, including those from NCI, lists every cancer
clinical trial.
Learning Objectives
By reading this section and completing the exercises, you
will be able to:
Identify who sponsors cancer clinical trials
Describe the role of NCI in how clinical trials
are conducted at sites throughout the United States
Describe the process by which people can be
referred to clinical trials
Explain ways to locate clinical trials
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NCI, pharmaceutical companies, medical institutions, and other
organizations sponsor clinical trials. NCI often partners with
pharmaceutical companies to develop new agents.
Regardless of sponsor, clinical trials take place at universities,
large medical centers, small hospitals, and doctors' offices.
Individual physicians at cancer centers and other medical
institutions can also sponsor clinical trials themselves.
NCI-Sponsored Clinical Trials
NCI sponsors many clinical trials around the country that are
conducted through four different programs:
Clinical Trials Cooperative Group Program
Community Clinical Oncology Program (CCOP) and the
Minority-Based Community Clinical Oncology Program (MBCCOP)
Cancer Centers Program
Clinical Grants Program
All NCI-sponsored trials must meet all FDA and Office for Human
Research Protections (OHRP) regulations for participant protection in
clinical trials.
Clinical Trials Cooperative Group Program
Clinical trials are often conducted through NCI cooperative
clinical trial groups, which are networks of institutions that
jointly carry out large clinical trials following the same protocols.
Members of these groups include:
Cooperative groups develop and conduct new clinical trials that
follow national priorities for cancer research. They conduct phase 3
trials as well as phase 2 trials.
Some of the groups are categorized by type of cancer, others by
type of treatment, and at least one by age of participants. Other
groups are regional or focus on several cancer types.
There are 12 groups in the Clinical Trials Cooperative Group Program:
American College of Surgeons Oncology Group (ACOSOG)
Cancer and Acute Leukemia Group B (CALBG)
Children's Cancer Study Group (CCSG)
Eastern Cooperative Oncology Group (ECOG)
Gynecologic Oncology Group (GOG)
Intergroup Rhabdomyosarcoma Study Group (IRSG)
National Surgical Adjuvant Breast and Bowel Project (NSABP)
National Wilms Tumor Study Group (NWTSG)
North Central Cancer Treatment Group (NCCTG)
Pediatric Oncology Group (POG)
Radiation Therapy Oncology Group (RTOG)
Southwest Oncology Group (SWOG)
For more information about the Cooperative Group program, see
http://ctep.info.nih.gov.
Community Clinical Oncology Programs (CCOPs) and Minority-Based
CCOPs (MBCCOPs)
These programs allow community physicians to work with scientists
conducting NCI-supported clinical trials. Participation in the CCOP
benefits lay people and health professionals in the community as well
as scientists in research centers.
The MBCCOP provides members of ethnic and racial minorities with
access to state-of-the-art cancer treatment, prevention, and control
technology.
Cancer Centers Program
NCI cancer centers conduct clinical trials under an NCI-approved
protocol review and surveillance mechanism.
The Cancer Centers Program consists of more than 50 NCI-designated
cancer centers involved in many different cancer research efforts.
Cancer centers also participate in at least one cooperative
group.
Clinical Grants Program
Many clinical trial protocols are carried out under the direct
support of an NCI peer-reviewed grant.
Industry-Sponsored Trials
Pharmaceutical and biotech companies conduct their own trials,
both locally and nationally. They may have as partners universities,
hospitals, NCI, or local doctors. These trials are subject to the
companies' own review panels and to an IRB, which may be local or
national in scope.
Referrals to Clinical Trials
Once someone is diagnosed with cancer, the health care provider
may suggest several possible treatment options, one of which may be a
clinical trial. Similarly, health care providers may offer people at
high risk for cancer several options for prevention, including a
clinical trial. If a person finds that his or her physician does not
participate in clinical trials, the person can request a referral to
a physician who does.
Decisions concerning eligibility for clinical trials are often
complicated, requiring very specific medical information about the
person's condition and previous treatment. For that reason, it is
always preferable to have a health care professional familiar with
the person's case make the initial contact with the clinical trials
team. People making calls directly may have insufficient medical
information, which may make decisions about eligibility difficult and
frustrating - for both the person making the call and for the
researcher taking the call.
Once contact with a clinical trial team is made, the clinical
trial staff assists potential participants and their health care
providers with information about potential clinical trials at the
institution. Depending on the institution, a referral coordinator,
protocol assistant, or nurse may accept telephone, mail, and e-mail
inquiries from physicians, potential participants, and others about a
clinical trial. Preliminary eligibility can be evaluated by phone,
and appointments with the clinical trial team can be scheduled.
Both patients and health care providers can find specific trials
through PDQ, NCI's comprehensive cancer trial database. For more
information on PDQ, see "Finding Information on Cancer and Clinical
Trials."
NCI Resources
NCI's Web site, www.cancer.gov,
provides access to a wealth of information on clinical cancer care.
The site contains information from PDQ, including the latest
information about cancer treatment, screening, prevention, genetics,
supportive care, and complementary and alternative medicine, as well
as a registry of cancer clinical trials. Clinical oncology
specialists review current literature from more than 70 medical
journals, evaluate its relevance, and synthesize it into clear
summaries, which are then reviewed monthly and updated as needed
based on new information. Most cancer information summaries appear in
two versions: 1) a technical version for the health professional, and
2) a nontechnical version for patients, their families, and the
public. Many of the summaries are also available in Spanish.
The NCI Web site also includes approximately 100 fact sheets on
various cancer-related topics, information on ordering NCI
publications, and educational features and news summaries concerning
the latest results from cancer clinical trials.
NCI's clinical trials registry (PDQ) contains more than 1,800
ongoing clinical trials, including information about studies around
the world. All clinical trials undergo review prior to inclusion.
Although no single resource lists every cancer clinical trial being
conducted in the United States and abroad, PDQ is the most
comprehensive cancer clinical trials registry; it contains
information about trials sponsored by NCI, the pharmaceutical
industry, and some international groups. Users can narrow their
search by multiple parameters, such as stage of disease, phase of
trial, treatment modality, and geographic location. PDQ also contains
an archival file of more than 11,000 clinical trials that are no
longer accepting patients, including contact information for the
principal investigators of trials that may not yet be published in
the biomedical literature.
Accessing NCI's Clinical Trials and Cancer Information by Phone
NCI's Cancer Information Service - NCI's Cancer Information
Service is a national information and education network for patients,
the public, and health professionals. From regional offices covering
the entire United States, Puerto Rico, and the U.S. Virgin Islands,
trained staff provide the latest cancer information through a
toll-free telephone service. Staff can respond to calls in either
English or Spanish. With regional offices throughout the United States, CIS staff members may work with organizations and professionals to plan, implement, and evaluate culturally appropriate clinical trials education programs using the Clinical Trials Education Series.
Access: The toll-free number is 1-800-4-CANCER (1-800-422-6237).
For deaf and hard of hearing callers with TTY equipment, the number
is 1-800-332-8615. Hours of operation are Monday through Friday, 9:00
a.m. to 4:30 p.m., local time. Callers also have the option of
listening to recorded information about cancer 24 hours a day, 7 days
a week.
NIH Web Site - It is important to note that there is no
single resource that lists every cancer clinical trial being
conducted in the United States and abroad. However, in 2000 the
National Institutes of Health launched a new Web site, www.clinicaltrials.gov,
that aims to be a complete listing of all U.S. Government- and
industry-sponsored clinical trials, including cancer trials.
The site contains approximately 7,200 clinical trials, most of
them Government-sponsored. However, additional trials from the
pharmaceutical industry are being added.
Other Web Sites
The Internet includes a variety of clinical trial databases and
matching services. The owners of these sites can be:
Not-for-profit organizations, where the content
providers may be volunteers and the site may be supported by an
academic institution or foundation
Companies that are heavily funded by investors who
pharmaceutical companies pay every time a patient signs up for a
clinical trial
Something in between (e.g., a for-profit organization
that gives some of its profits back to the cancer community)
Anyone interested in using any of these online services to find a
clinical trial should ask a number of questions and evaluate the
information before submitting personal information or calling an
investigator from the service:
Who owns/runs the site?
Where does the financial backing come from?
How does the service get paid? By matching people to
trials? By clinical trial submission to the database? Other?
Does anyone make money on this site? If so, then
who?
What is the source of clinical trial information?
Does the site include all clinical trials? All
Government-supported trials? All pharmaceutical trials?
Most people would like to have all of their treatment/prevention
choices presented in an unbiased way before they make important
health-related decisions. People may wish to look at the information
from many of these sites and consider the source of the information
before deciding what actions to take.
Guide To
Finding Clinical Trial Resources
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National Cancer Institute's PDQ
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What is it?
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How do I access it?
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What will it provide?
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Database produced by NCI
Registry of approximately 1,800 active cancer clinical
trials
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www.cancer.gov
Go to the clinical trials area and follow the search
directions OR Call 1-800-4-CANCER
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Summaries about clinical trials conducted by
NCI-sponsored researchers, the pharmaceutical industry, and
some international groups
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National Library of Medicine
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Database produced by NIH Registry now lists 4,000
primarily NIH-supported clinical studies on many conditions,
and more will be added
All trials on PDQ are listed in this database
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Go to www.clinicaltrials.gov
Can browse by disease or sponsor or insert key words
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Summaries about clinical trials for a wide range of
conditions-
most of the trials listed are sponsored by NIH
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Local Cancer Center Web Sites
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Locally produced Web sites that include listings for
trials sponsored by NCI and some pharmaceutical
companies
Good supplementary resources for locating clinical
trials; a cancer center may begin participating in an
NCI-sponsored trial before the center's information is
listed in PDQ
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Different sites can be found through:
Information on trials taking place at NCI's Clinical
Center in Bethesda, Maryland is available at http://ccr.nci.nih.gov then select "clinical trials"
Some centers may also have telephone information
centers
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Information that varies from center to center
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Example of Pharmaceutical Resources/Internet Clinical
Trial Matching Sites
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Pharmaceutical Research and Manufacturers of America
(PhRMA) publishes a list of new cancer drugs in
development
CenterWatch's Clinical Trials Listing Service and EmergingMed.com's clinical trials matching service lists many
industry- and Government-sponsored trials
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PhRMA
Click on "New Medicines in Development" and search by
disease. The drugs are listed by cancer type or call 202-835-3400.
CenterWatch
Click on "Trial Listings" and then "CenterWatch Trial
Listings by Medical Areas" or call 617-856-5900
EmergingMed.com or call 877-601-8601
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Descriptions, sites, telephone numbers, and investigator
names by state
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Barriers to Participation
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Exercise 5.1
Involvement in Clinical Trials
If a doctor seems too busy to refer a person to a clinical trial,
can the person make the calls directly?
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Answers to Exercise 5.1
Exercise 5.2
Using PDQ to Locate Clinical Trials in Your Community
Choose two cancer diagnoses from the list below. Using www.cancer.gov,
locate at least three clinical trials going on in your city or
state.
When you have found at least three open trials, print out the
patient versions and answer the question below. You can use NCI's PDQ
or ask for printouts by calling 1-800-4-CANCER.
A. Someone diagnosed with stage II ovarian cancer who is looking
for treatment options in your city and state
B. Someone diagnosed with stage IV colon cancer who needs options
for supportive care
C. Someone diagnosed with stage III small cell lung cancer who
needs options for treatment
D. Someone who is found to be at high risk for breast cancer who
needs options for prevention
Question
What did you learn about clinical trials in your community or
State?
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