6. Conducting, Referring to, and Locating Clinical Trials
Sponsorship
Making Referrals
Cancer Information and Clinical Trial Resources
Describe the types of sponsorship of cancer
clinical trials
Define the role of the National Cancer Institute
in conducting clinical trials throughout the United
States
Identify methods of referring patients to clinical
trials
Demonstrate ways of locating clinical trial
resources
|
In order to find a clinical trial, it is helpful to understand who
sponsors trials. Clinical trials are sponsored by both Government and
private organizations including the National Cancer Institute and
pharmaceutical companies. Clinical trials take place all over the
United States, in locations as diverse as a rural community clinic or
a cancer center in a large urban area.
National Cancer Institute
NCI sponsors hundreds of clinical trials around the country
through six major programs, which are discussed below.
Clinical Trials Cooperative Group Program
The Clinical Trials Cooperative Group Program supports a large
network of organizations that continually generate and conduct new
clinical trials consistent with national priorities in cancer
treatment research. Member organizations carry out large, randomized
phase 3 trials, as well as phase 2 trials.
Members conduct clinical trials in locations nationwide, while
administration and data are handled at a central location. Members of
the groups include:
Academic institutions
NCI-designated cancer centers
Physicians in the Community Clinical Oncology Program
and the Minority-Based Community Clinical Oncology Program
(described below)
Community physicians and community hospitals
Each year, the groups enroll some 20,000 new people in treatment
trials, evaluate some 12,000 new participants in ancillary studies,
and follow the progress of many times that many participants in
ongoing trials. Thousands of individual investigators participate in
these studies. The cooperative groups have been instrumental in
developing both new standards of care for people with cancer and
sophisticated clinical investigation techniques.
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 cooperative group information, see http://ctep.info.nih.gov.
Select "Cooperative Group Program."
Cancer Trials Support Unit
NCI and the Clinical Trials Cooperative Group Program are
collaborating in a pilot project - the Cancer Trials Support Unit
(CTSU) - to reduce administrative burdens and recruit more physicians
to become involved in clinical trials.
CTSU is designed to streamline and centralize many administrative,
financial, and data collection tasks. CTSU will provide participating
physicians with a single access point to NCI's entire phase 3
clinical trial system, facilitating access to protocols, training,
and educational information. Highlights of the fully developed system
will include:
Cross-group registration enabling physicians to
register people on adult cooperative group trials in leukemia,
lung, genitourinary, colorectal, and breast cancers, even if they
are not members of the group conducting the trial
Online registration, eligibility assessment, and
reporting of data that will use a common format and
state-of-the-art data management systems
A coordinated auditing system that will eliminate
multiple quality assurance audits for research personnel
participating in more than one cooperative group
Centralization of administrative tasks, including
credentialing and verification of IRB approval for all
investigators participating in cooperative groups and CTSU
CTSU opened in July 2000 for cooperative group members. If the
initial experience is successful, oncologists not affiliated with a
group will be encouraged to participate as well.
For more information about CTSU, see www.ctsu.org.
Community Clinical Oncology Program
The Community Clinical Oncology Program (CCOP) enables community
physicians to work with investigators conducting NCI-supported
clinical trials. The program increases the number of participants and
physicians who can take part in clinical trials operated
simultaneously in major research centers and in the community. It
benefits investigators by giving them an opportunity to conduct
large-scale cancer prevention and control studies at the community
level.
Facilities participating in the program must be affiliated with an
NCI-supported clinical cooperative group or cancer center and use
research protocols developed by these groups.
Minority-Based Community Clinical Oncology Program
The Minority-Based Community Clinical Oncology Program (MBCCOP)
was initiated in 1990 to provide people with cancer who belong to
minority groups access to state-of-the-art treatment, prevention, and
control technology. The minority-based program was begun because 40
percent of the people with cancer referred to CCOP physicians each
year are from a minority group. Each MBCCOP pledges to accrue more
participants from minority groups than other CCOPs do.
Since funding began, participant enrollment in the minority-based
program has grown to account for approximately 10 percent of all
ethnic minorities enrolled in NCI-approved clinical trials.
Cancer Centers Program
The Cancer Centers Program consists of more than 50 NCI-supported
research centers. Each cancer center also belongs to at least one
cooperative group.
NCI supports three types of centers:
Comprehensive cancer centers, which conduct basic, clinical,
and preventive research programs, as well as community outreach and
education programs
Clinical cancer centers, which conduct primarily clinical
research programs but may have programs in other research areas as
well
Cancer centers (formerly called Basic Science Cancer Centers),
which conduct basic or preventive research programs and do not have
clinical programs
Please refer to http://cancercenters.cancer.gov/cancer_centers/index.html
for a comprehensive list of cancer centers.
Clinical Grants Program
The Clinical Grants Program supports clinical researchers through
various types of grants, all of which are peer reviewed.
Pharmaceutical and Biotech Companies
Pharmaceutical and biotech companies also conduct clinical trials,
both locally and nationally. They may conduct these trials in
collaboration with universities, hospitals, NCI, and local
physicians. These trials are subject to the companies' own review
panels and to an IRB, which may be local or national in scope.
When a person is first diagnosed with cancer, his or her physician
may suggest several possible options for treatment, possibly
including a clinical trial. Likewise, a person at high risk of
developing cancer may be offered prevention options that include a
clinical trial.
Decisions concerning eligibility for cancer clinical trials are
often complicated, requiring very specific information regarding a
person's medical condition and prior treatment. For that reason, it
is preferable to have a provider who is familiar with the person's
case make the initial contact with clinical trial staff. A person who
calls a researcher directly may have insufficient medical
information, thereby making a decision about eligibility difficult
and frustrating for both the potential participant and the
researcher. Once contact is made, a referral coordinator may accept
telephone, mail, or e-mail inquiries from physicians, potential
participants, and others about the availability of clinical trials.
Preliminary eligibility can be evaluated over the phone, and
appointments with the clinical trial team can be scheduled if the
person decides to proceed.
The informed consent process begins as soon as a potential
participant begins to explore the trial with the clinical research
team. The research team discusses the trial's purpose, procedures,
risks, potential benefits, and participants' rights. After this
dialogue, the person may wish to speak to his or her referring
provider to review the information and help determine the best
course.
If the person opts to enter the trial, the research team should
send the referring provider relevant updates and followup information
until the person returns to the provider's care.
Deciding to refer a person to a clinical trial is easier if the
health care professional has adequate information regarding the
trial's objectives and eligibility criteria. Before discussing a
trial as an option, the professional should learn as much as possible
about the trial.
Discussing Clinical Trials with Patients
Health care professionals may be able to assist potential trial
participants in their decision by considering the following benefits
and risks to clinical trial participation with their patients.
Possible Benefits of Clinical Trial Participation
Participants will receive, at a minimum, the best
standard treatment. This may be as good as, or better than, the
new approach being tested.
If a participant is taking the new treatment and it is
shown to work, he or she may be among the first to benefit.
By examining the benefits and drawbacks of clinical
trials and other treatment choices, participants are taking an
active role in a decision that affects their health care and
life.
Some participants feel good about helping advance
medical knowledge that will improve cancer care and help
others.
Even when they don't lead to new therapies, clinical
trials often answer important questions and help move research
forward.
Possible Risks of Clinical Trial Participation
New treatments are not always better than standard
care.
New treatments may have unexpected side effects that are
worse than those of standard treatment.
Although a new treatment is beneficial, it may not work
for every participant. Even standard treatments do not help
everyone.
If a participant receives standard treatment instead of
the new treatment being tested, it may not be as effective as the
new approach.
Participants may have additional patient care costs that
are not covered by the study sponsor or by their health insurance
or managed care plan.
Participants may have to incur the costs of travel,
childcare, lost work hours, hotels, and meals.
Participation in a clinical trial may require increased
patient responsibility, such as going to more appointments or
self-monitoring for side effects.
NCI Resources
NCI's Web site, Cancer.gov,
provides access to a wealth of information on clinical cancer care.
The site contains information from PDQ® (Physician Data Query), 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 also has a Web-based continuing education tutorial on implementing clinical trials into your practice.
This tutorial provides information for health care professionals interested in referring patients to trials, and more detailed information for health care professionals interested in actually implementing clincial trials into their practice. The series is available at cme.cancer.gov.
The clinical trials registry PDQ contains more than 1,800 ongoing
clinical trials, with information about trials 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, and 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 participants, including
contact information for principal investigators of trials that may
not yet be published in the biomedical literature.
Accessing NCI's Clinical Trial and Cancer Information by Phone or
Fax
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. The Cancer Information Service, with regional offices throughout the United States, 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
No single resource 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, that might:
For-profit organizations, that might:
Anyone interested in using online services to find a clinical
trial should ask 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, who?
What is the source of clinical trial information?
Does the site include all clinical trials? All
Government-supported trials? All pharmaceutical trials?
People may wish to look at information from many sites and
consider the source of the information before making important
health-related decisions.
Guide To
Finding Clinical Trial Resources
|
National Cancer Institute's PDQ
|
What is it?
|
How do I access it?
|
What will it provide?
|
Database produced by NCI
Registry of approximately 1,800 active cancer clinical
trials
|
Cancer.gov
Go to the clinical trials area and follow the search
directions OR Call 1-800-4-CANCER
|
Summaries about clinical trials conducted by
NCI-sponsored researchers, the pharmaceutical industry, and
some international groups
|
National Library of Medicine
|
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
|
Go to www.clinicaltrials.gov
Can browse by disease or sponsor or insert key words
|
Summaries about clinical trials for a wide range of
conditions - most of the trials listed are sponsored by
NIH
|
Local Cancer Center Web Sites
|
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
|
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
|
Information that varies from center to center
|
Example of Pharmaceutical Resources/Internet Clinical
Trial Matching Sites
|
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 list many
industry- and Government-sponsored trials
|
PhRma.org
Click on "New Medicines in Development" and search by
disease. The drugs are listed by cancer type. Or call 202-835-3400.
CenterWatch.com
Click on "Trial Listings" and then "CenterWatch Trial
Listings by Medical Areas" or call 617-856-5900
EmergingMed.com or call 877-601-8601
|
Descriptions, sites, telephone numbers, and investigator
names by state
|
Refer to the case study for a review and summary of content covered in this workbook.
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