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Prospective Patients Section -- Introduction
Clinical research depends on people who are willing to
participate in clinical trials as research subjects. Clinical
trials test the best way to treat, prevent and control cancer.
The progress made today through the clinical trials process
improves tomorrow's standard care medicine.
Only 3% to 5% of adult cancer patients actually participate
in cancer clinical trials while approximately 20% may be
eligible. The rate of clinical trials participation determines
how fast we advance the science. Educating the public and
increasing their awareness of cancer clinical trials is the
first step towards increasing clinical trials participation.
What's important about participating in a clinical trial
offered through the Colorado Cancer Research Program?
- The primary sponsor of the clinical trials offered
through the Colorado Cancer Research Program (CCRP) is
National Cancer Institute (NCI). These are NCI Phase II and
Phase III cancer clinical trials.
- Clinical trials offer cancer patients a treatment
option. Becoming informed is taking an active part in your
decision-making. All clinical trials are not the best
treatment choice for all patients.
- Taking part in a cancer clinical trial is one way to
receive high quality care from cancer specialists. Trained
research specialists carefully and continually monitor
clinical trial participants.
- In Phase III trials, the clinical trials participant
receives the best available current treatment or a new
approach that doctors believe may work better than the
standard method.
- Taking part in a clinical trial means the individuals
are among the first to receive the latest drugs, procedures,
and treatment or prevention approaches before the treatment
is publicly available.
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The Decision to Participate Is Yours
Before you decide to participate in a clinical study, your
doctor will discuss the potential benefits and risks with you.
Your doctor's input is very important. His or her insight and
knowledge of your medical history and condition are the best
basis for treatment selection. The ultimate decision, however,
is always yours. Patients who take part in research studies may
benefit themselves, as well as future patients.
Control Group vs. Intervention Group
All the studies may use a 'Control' Group to compare with an
'Intervention' Group: The Control Group receives the best
standard treatment or care available. The Intervention Group
receives the new drug or therapy approach being tested by the
study. In almost all cases, the patient will receive either the
best available standard treatment or a new study treatment.
"Blinding" in Clinical Research
Blinding keeps one or more parties involved in conducting the
trial unaware of the treatment assignment. In a "single-blinded
clinical trial, the participant is unaware of which treatment
she/he is receiving. In a "double-blinded" trial, neither the
physician nor the study participant know which group the
participant is in. Double-blinded trials are valuable for
eliminating the observer's bias in studying the treatment
effect. In special medical situations, if a doctor needs to find
out which study drug the participating patient is on, this is
possible through the study sponsor's office.
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Protection of Patient Safety
Once an individual becomes a research participant a process
begins for protecting the individual as a human subject.
Individuals participating in the research have the right to be
protected against harmful risks by research interventions of new
drugs and/or procedures being tested.
Some of the regulatory patient-protection safeguards that
clinical trials must comply to are the following:
- Human Subjects Protection Training. Participating
physicians who enroll patients in clinical trials must be
approved annually by the National Cancer Institute and are
required to have Human Subjects Protection Training. The
intent of this training guides the physician in how to
protect the rights and welfare of all human participants in
research.
- Informed Consent. Each individual, as a clinical trial
participant, must be informed of the potential risks and
benefits of the research study they are considering and must
give signed consent to participate.
- Institutional Review Board (IRB):
- Reviews and approves each protocol activated by the
Colorado Cancer Research Program.
- Is comprised of scientific and lay members.
- Is responsible for evaluating new and ongoing
clinical trials on the basis of scientific, legal and
ethical merit.
- Assumes the responsibility to assure that no
unreasonable risks, compared to potential benefits, are
taken.
In protecting each research participant, Colorado Cancer
Research Program adheres to the standards for scientific
integrity recognized around the world. The Colorado Cancer
Research Program respects the dignity of research participants
with regard to self-determination and full disclosure of
information throughout the research process.
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About Prevention Clinical Trials
Prevention trials are a relatively recent addition to
clinical research. They provide the potential means to reduce
the incidence of cancer, to delay its onset, and to reduce
cancer-related death and disability. Some of today's prevention
clinical trials are testing dietary and drug approaches that may
reduce the risk of developing some cancers. The prevention
research seems particularly important to people with special
risks for cancer, such as having a history of cancer in the
family. These participants elect prevention clinical trials as a
way to be a part of the solution and to possibly prevent getting
cancer.
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After assessing the patient's disease and the necessary
therapy for treating the disease, the doctor may consider a
clinical trial for the treatment. When this happens he/she
determines which particular cancer protocol might be
appropriate. The doctor studies the protocol's eligibility
criteria to see whether the patient is a potential candidate and
offers the patient the cancer trial as a treatment option. The
patient will be asked to first read the informed consent to more
fully understand the trial before making any decisions. Once the
consent form is signed, the patient's assignment into the study
is randomized.
What Is a Protocol?
A trial's protocol:
- Provides the blueprint for how a trial is conducted.
- Defines the trial's action plan.
- Explains the purpose of the clinical trial.
- States the research question the trial is designed to
answer.
- Defines who is and who is not eligible to participate.
- Outlines what will be done in the trial, for example how
much of a drug will be given, how often it must be taken,
and what medical tests will be required to check on the
progress of the study.
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Why Are There Eligibility Criteria?
- To define the entrance and exclusion factors to first
protect the patient safety.
- To ensure that the new treatment or approach is being
tested on similar groups of people, i.e. to compare apples
to apples.
- To assure key similarities among participants, e.g., the
same type and stage of cancer.
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What is Informed Consent?
An informed consent:
- Is a key part of a clinical trial. Participants should
ask questions until he or she feels comfortable enough to
make an informed consent.
- Is an ongoing process, meaning the participant should
receive any new information about the treatment as it is
learned.
- Explains key facts of the clinical trial - what will be
done in the trial, what type of therapy will be conducted,
i.e. radiation, chemotherapy, variation of drug dosages etc,
and how long will the intervention last.
- States the potential benefits and potential risks of the
clinical trial.
- States the possible side effects of treatment.
- Explains what kinds of tests will be conducted (x-rays,
blood tests) during the trial to monitor study response.
- Means the participant understands what is involved in
the trial, including its potential benefits and risks of
participating.
- Must be signed by each participant. Individuals can
freely decide to take part in the trial or not.
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Why Are Participants Randomized?
Researchers need for clinical trials to provide non-biased
information. The randomization process eliminates bias. A
clinical trial can have two or more treatment assignments (also
referred to as 'arms') that are being examined. For example, a
drug study may compare the dosage of Arm "a" to Arm "b" and Arm
"c".
The randomization process:
- Validates whether the new treatment (intervention) is
superior to the standard (control) treatment.
- Prevents a bias or partiality in assignment to a
specific group.
- Uses computer assignment to randomly and anonymously
assign to insure that trial results are scientifically
valid.
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The research role of the Colorado Cancer Research Program is
to:
- Facilitate the processes to support the cancer doctor to
enroll a cancer patient in a cancer protocol.
- Provide a qualified research nurse to coordinate all
patient pre-entry and on-study requirements and to provide
on-going patient/family education while the patient is
receiving treatment.
- Ensure Good Clinical Practices in the conduct and
monitoring of individuals participating in a clinical trial.
- Ensure high standards for data management that meet or
exceed National Cancer Institute's quality assurance
requirements for the submitting a participants' study data
information.
- Ensure compliance with U.S. Federal Drug
Administration's requirements for the handling and
accountability of the investigative drugs used in the
trials.
- Participate in Quality Assurance Audits required by the
National Cancer Institute (and the cooperative research
groups) to assure research integrity in the conduct of human
subjects research.
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