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About Clinical Trials Section
Everyday, medical research provides doctors with more
information about fighting cancer. Hope and promise come from
scientific discoveries. These discoveries are made available to
people through the process of cancer clinical trials and by the
people who participate in clinical trials.
What Is a Clinical Trial?
- Part of the research process that begins at the
laboratory.
- A research study conducted with actual people.
- A controlled and monitored study process under which new
drug treatments or new approaches for diagnosing,
controlling or preventing cancers are compared to what is
currently available.
- A study designed to answer key scientific questions that
will advance medical knowledge.
- Always a voluntary choice for participation.
Why Are Cancer Clinical Trials Important?
Most of today's standard care medicines are the results of
yesterday's clinical trials. Clinical trials:
- Provide the viable link between the advancements made in
medical science to the resulting improvements made in
standard care medicine.
- Demonstrate the effectiveness of new approaches to
treating a cancer, controlling the side effects of
chemotherapy, or preventing the cancer altogether.
- Use an evidence-based process to test and then make
conclusions of a drug or treatment's safety and
effectiveness.
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Four Types of Cancer Clinical
Trials
- Treatment Trials - effort
is to find superior drugs or test for better approaches in
using surgery or radiation for treating people who already
have cancer.
- Prevention Trials - test
new approaches, such as certain medications, vitamins,
minerals or food supplements, which may lower a person's
risk of a certain type of cancer. These trials are for
reducing the risk of developing cancer in healthy people who
do not have cancer, or preventing the return of cancer in
those who have already had cancer.
- Diagnostic/Screening Trials
- compare new techniques for finding cancer, especially
early-stage cancers.
- Supportive Care (also Quality of
Life) Trials - test new ways to improve comfort and
quality of life for people with cancer. Some of these trials
may also be referred to as "symptom control" trials that
address the pain and nausea that often accompanies
chemotherapy.
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How Are Clinical Trials Tested?
Clinical trials are conducted in phases. Rigorous testing at
each phase is desired. The answers received from Phase I
determines whether the treatment will progress to Phase II and
then to Phase III. Each phase serves a specific purpose:
- Phase I - This first point
of testing is primarily concerned with safety (how toxic is
the treatment?) and the best way to deliver the new
treatment.
- Phase II - This level tests
effectiveness of a treatment for specific tumor types. They
are designed to find out whether the agent has an anticancer
effect, whether it will reduce tumor size or alleviate
symptoms.
- Phase III - For treatment
trials, this phase compares the new therapy with the best
available treatment currently known, i.e. is one approach
more effective than another. In cancer prevention trials the
agent (drug, vitamin) compare the outcome of one agent to
another, or compare the results of taking a drug versus
taking no drug.
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Where Are Cancer Clinical Trials
Conducted?
Mammogram imaging is used for cancer diagnosis. (National
Cancer Institute photo by Rhoda Baer)
In the past, patients could access clinical trials only if
they lived near large teaching hospitals or major medical
centers or if they were able to travel long distances to these
institutions.
Today, clinical trials are made accessible through
community-based cancer centers, community hospitals and
physician offices and local outpatient cancer clinics. These
venues provide cancer patients and individuals-at-risk for
cancer greater opportunity to access many of the same trials
once available only through major cancer centers.
Sponsored by both the federal government and/or private
industry, cancer clinical trials are conducted through a variety
of institutions:
- National Cancer
Institute (NCI) - Most often thought of as merely a
funding source that funds cancer research, the NCI, a
federal government agency, serves also as a resource and
clearinghouse for patients, health professionals and the
general public. The NCI publishes vast information on
cancer, the cancer research it funds, and grant funding
opportunities. Cancer Information Service 1-800-4-CANCER.
- Cooperative Groups
- Throughout the United States and Canada approximately 11
cancer cooperative groups conduct large-scale clinical
trials. The types of clinical trials offered through these
cooperative groups are varied: The Radiation Therapy
Oncology Group trials, for example, focus on single
treatment modality, radiation therapy. The National Surgical
Breast and Bowel Project Group's trials focus on treatment
and prevention of breast and colon/rectal cancers. The
Eastern Cooperative Group, on the other hand, is a
multi-modality group offering trials that focus on
multi-disciplinary treatment that may include radiation
therapy plus chemotherapy and for all cancer sites. These
cooperative group trials are offered to and conducted by
community cancer programs and community hospitals, teaching
hospitals, etc.
- Community Clinical Oncology
Programs - There are 60 NCI-designated community
oncology programs referred to as Community Clinical Oncology
Programs (CCOP). The Colorado Cancer
Research Program is an NCI-designated CCOP that
reaches out into local communities to conduct cancer
clinical trials. CCOPs are located in 34 states, the
District of Columbia and Puerto Rico. These community-based
cancer programs offer large-scale cancer clinical trials to
people in local communities.
- Cancer Centers - Throughout
the United States, the NCI has designated approximately 60
institutions as Comprehensive Cancer Centers. These Cancer
Centers are often located in institutions of higher
learning, such as teaching hospitals and medical centers
that treat cancer patients as well as participate in
research. Their research is comprehensive - meaning it
includes basic laboratory research, clinical research, and
prevention and control research.
- Pharmaceutical/Biotech Companies
- More than 80 pharmaceutical/biotech companies conduct
cancer clinical trials research, often early phase and drug
advancement studies.
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