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.
Magnetic Resonance
Imaging (MRI) machine used in cancer diagnosis. (National Cancer Institute
photo)
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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