| Q. What is a clinical study?
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| A. A clinical study or
clinical trial is designed to test the effects of medication,
medical treatment or device on a group of volunteers.
These studies are used to measure the drug's ability to treat a
condition, safety, and a drug's possible side effects. |
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| Q. Who can be in a clinical
study? [back to top] |
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| A. People with the
condition the drug is developed for as well as people who are
healthy can volunteer to participate in a study. The FDA
has strict requirements as to whether a study will involve
healthy people or just people with the condition being studied.
Each
study has its own requirements and they can include requirements
like age, sex, or a medical condition for a person to
qualify. In addition to the study requirements the
physician will review each participants medical history and the
study requirements to determine who can participate. Known
risks and discomforts will be explained by the study physician
prior to a volunteers participation in a study. In
addition to the known risk, there may also be some unknown
medication side effects involved in participating in a clinical
study. The procedures, risks, and benefits are explained
to potential participants during the informed consent process.
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| Q. What is informed
consent? [back to top] |
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| A. Informed consent is a
process designed to ensure that volunteers have all the
information they need to decide whether or not they want to
participate in the study. This process allows the
volunteer to ask questions and exchange information with
the clinical investigator. The clinical investigator is
responsible for ensuring that informed consent is obtained
before a volunteer is allowed to participate in the study. |
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| Q. How is a drug approved for
testing? [back to top] |
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| A. The U.S. Food and Drug
Administration or FDA typically must authorize a drug company's
proposal to conduct a clinical study. Before the FDA gives
authorization for a study a drug company must do years of
preclinical or laboratory research before they can begin testing
in humans. This research often involves years of
experiments with animal and human cells. The compounds are
also extensively tested in animals. If this stage is
successful the pharmaceutical company provides this data to the
FDA requesting approval to begin testing in humans. |
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| Q. How are experimental drugs
tested in humans?
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| A. The clinical testing
of experimental drugs is normally done in three phases, each
successive phase will involve a larger number of volunteers. |
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| Q. What is the difference
between the phases of a study?
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A. Phase I Study
Phase I studies studies are concerned with the drug's safety.
This phase of testing is performed on a small number of
healthy volunteers. The study is designed to determine
what happens to the drug in the human body -- how it is
absorbed, metabolized, and excreted. A Phase I study also
investigates side effects as the dosage level is increased.
This initial phase of testing generally takes several months.
Phase
II Study
Phase
II studies are concerned with the drug efficacy or
effectiveness. This phase is only conducted after the drug
is shown to be safe. The second phase of testing can
involve several hundred patients. Most Phase II studies
are randomized trials. One group of patients will receive
the experimental drug while the second "control"
group will receive the standard treatment or placebo.
These studies are often blinded which means neither the
patients nor the researchers know who is getting the
experimental drug. When a study is blinded it can provide
the pharmaceutical company and the FDA with the relative safety
and effectiveness of the new drug.
Phase
III
In
a Phase III study, a drug is tested in several hundred to
several thousand patients. The large scale of this phase
provides the pharmaceutical company as well as the FDA with a
more thorough understanding of the new drug's effectiveness,
benefits, and the range of possible adverse reactions.
Most Phase III trials are blinded and randomized. Once the
Phase III trial is completed the pharmaceutical company can
request FDA approval to market the new drug.
Phase
IV
Sometimes pharmaceutical companies will initiate another study
which can be called a post-marketing or a Phase IV study.
In Phase IV studies pharmaceutical companies have several
objectives.
- The study will often compare a drug with other drugs
already in the market.
- The study is often designed to monitor the drug's
long-term effectiveness and impact on a patients quality of
life.
- Many of the studies are designed to determine the cost
effectiveness of a drug therapy relative to other
traditional and new therapies.
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| Q. Who pays for
clinical research?
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| A. Funding for clinical
research comes from both the government (through the National
Institutes of Health) and private industry (the pharmaceutical
and biotech companies). The sponsor of the research
hires the physicians who may work in a wide variety of health
car settings, to conduct the clinical trial. The
physicians are typically paid on a per patient basis. The
medical care is provided for free to the patient. Patients
may also be paid for their participation for in the clinical
trial. |
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| Q. Should I volunteer?
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| A. Volunteering to
participate in a clinical drug study is one of the best ways you
can contribute to the understanding of diseases that affect
people and the development of new therapies. Volunteers
are important to the clinical study phase of the drug approval
process. As a volunteer, you are the most criticallink in
a long chain of research and testing in the development of new
medications for a broad range of health problems. |
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