Prospective Patients Section -- Introduction
(National Cancer Institute
photo by Bill Branson)
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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(National Cancer Institute
photo by Bill Branson)
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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