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F.A.Q.'s - Frequently Asked Questions
1. What is a "clinical trial"?
2. What is a "protocol"?
3. What are the "phases" of research for a new drug?
4. How are the patients' rights and safety protected?
5. What are the responsibilities of a Study Volunteer?
6. Who sponsors clinical trials?
7. What is a "placebo"?
8. What is a "control" or "control group"?
9. Will I be paid for participating in a clinical trial?
1. What is a "clinical trial"?
Clinical trials are research studies to learn more about new medicines,
vaccines, and treatments. Also called "medical research" or
"research studies", a clinical trial aims to discover the effectiveness
and safety of the therapy. The clinical trial measures the ability of
the new medication to treat a disease or condition.
2. What is a "protocol"?
A protocol is the set of rules that guide the clinical trial. Each clinical
trial has its own specific protocol. Protocols answer questions such as:
"What types of volunteer may participate in the trial?"
"What is the schedule of tests, procedures, medications, and dosages?"
"What is the length of the study?"
Protocols are the carefully designed instructions for the treatment given
in a clinical trial. It is important for physicians and volunteers to
adhere to protocols.
3. What are the "phases" of research for a new drug?
Promising new medications are first tested extensively in labs using human
cells and animal subjects. If the therapy shows promise, it moves into
the clinical trials process.
The clinical testing of experimental drugs is normally done in four phases,
each successive phase involving a larger number of people.
Phase I
# of volunteers: 20-100
Length of trial: usually a few months
% of medicines that succeed this phase: ~ 70%
Phase I studies are primarily concerned with determining the drug's
safety. This initial phase of testing in humans is done in healthy volunteers,
who are usually paid for participating in the study. The study is designed
to determine what happens to the drug in the human body--how it is absorbed,
neutralized, and excreted. A phase I study will investigate side effects
that occur as dosage levels are increased.
Vital re:Search does not participate in this phase of research.
Phase II
# of volunteers: 100-300
Length of trial: a few months - 2 years
% of medicines that succeed phase II: ~ 50%
Once a drug has been shown to be safe in phase I, it must be tested
for efficacy ("efficacy" - the power to produce desired effects)
in phase II. Most phase II studies are randomized trials. This means
that one group of patients will receive the experimental drug, while
a second "control" group will receive a standard treatment
or inactive medicine (placebo). Often these studies are "double-blind"--neither
the patients nor the researchers know who is getting the experimental
drug. In this manner, the study can provide the pharmaceutical company
and the FDA comparative information about the relative safety of the
new drug, and its effectiveness.
Vital re:Search does participate in Phase II studies.
Phase III
# of volunteers: 1,000-3,000
Length of trial: usually several years
% of medicines that succeed in phase III: between 70-90%
In a phase III study, a drug is tested in several hundred to several
thousand patients. This large-scale testing provides the pharmaceutical
company and the FDA with a more thorough understanding of the drug's
effectiveness, benefits, and the range of possible side effects. Most
phase III studies are randomized (patients are selected randomly, ie:
"flip of the coin") and blinded (neither patient nor doctor
know what treatment group the patient is in) trials. Once a phase III
study is successfully completed, a pharmaceutical company can request
FDA approval for marketing the drug.
Vital re:Search frequently participates in Phase III studies.
Phase IV
Phase IV studies are done after the drug or treatment has been marketed.
In late phase IV studies, pharmaceutical companies have several objectives:
(1) studies often compare a drug with other drugs already on the market;
(2) studies are often designed to monitor a drug's long-term effectiveness
and impact on a patient's quality of life; (3) many studies are designed
to determine the cost-effectiveness of a drug therapy relative to other
traditional or new therapies; (4) new indications may be found for an
already approved drug.
Vital re:Search participates in Phase IV studies.
4. How are the patients' rights and safety protected?
IRB: Before a clinical trial begins, the physician conducting the study
must receive permission from an Institutional Review Board ("IRB").
An IRB is an independent committee of physicians, statisticians, community
advocates, and others that ensures that a clinical trial is ethical and
the rights of study participants are protected. In addition to examining
the protocol prior to a trial's commencement, an IRB will periodically
monitor a trial to ensure that risks to the patients are minimized.
Informed Consent: The second means by which patients rights and safety
are protected is through "Informed Consent". It is an ongoing
process during the study. It begins with a form that volunteers sign,
detailing the nature of the study, the risks involved, and what may happen
to a patient in the study. The form also explains to patients that they
may leave the study at any time.
Questions that the "informed consent" should answer are:
What does the researcher want to accomplish?
What will be done during the trial?
What is the expected length of the trial?
What are the risks involved?
What benefits can be expected from the trial?
What other treatments are available?
5. What are the responsibilities of a Study Volunteer?
Follow the study directions as outlined in the protocol. For example,
take medication as directed, answer a questionnaire, attend study appointments,
ask ongoing questions you have about the research study, and keep in contact
with the study doctor and study nurse.
6. Who sponsors clinical trials?
Clinical trials are sponsored by government agencies (eg: the NIH), pharmaceutical
and biotechnology companies, individual physicians, health care institutions
(eg: Duke and UNC Medical Centers), and organizations that develop medical
devices or equipment.
7. What is a "placebo"?
A placebo is an inactive pill, liquid, or powder that has no treatment
value. In clinical trials, experimental treatments are often compared
with placebo to assess the treatment's effectiveness. In some studies,
the participants in the control group will receive a placebo instead of
an active drug or treatment.
8. What is a "control" or "control group"?
A control is the standard by which experimental observations are evaluated.
In clinical trials, the control group is given either a standard treatment
or a placebo. The experimental group of patients will be given the new
drug or treatment.
9. Will I be paid for participating in a clinical trial?
Please see our BENEFITS OF PARTICIPATION
page for a fuller explanation. Some clinical trials will pay you for joining
the trial, while others will not. The medical care is usually provided
free to the patient. In some programs, researchers will reimburse you
for expenses associated with participating in the research. Such expenses
may include transportation costs, child care, meals, and accommodations.