Many doctors at Akron General
Medical Center study the nature of disease and attempt
to develop improved methods of diagnosis and treatment
through the clinical trials process. Akron General
Medical Center participates in National Cancer Institute
sponsored trials, pharmaceutical industry trials
and studies initiated by Akron General Medical Center
Clinical trials, also called research
studies, answer specific scientific questions to
find better ways to prevent, diagnose and treat
disease. Clinical trials test many types of treatments.
These may include new drugs or new combinations
of drugs, new ways of using known therapies or new
approaches to treatments, such as radiation therapy
Clinical trials are conducted
in four phases. Each phase has a different purpose
and answers different questions.
Phase I clinical trials-
are usually the first step in treating human participants.
Side effects and safe dosage are determined. This
phase of a clinical trial usually has a limited
number of participants who would not be helped by
other known therapies.
Phase II clinical trials-
look at whether the new treatment has any effect
on a specific disease. Side effects and safety are
also monitored. A limited group of people also participate
in this phase of testing because risks and unknown
side effects are still being established. There
is no comparison to a standard treatment in a Phase
Phase III clinical trials-
large groups of people participate in Phase III
clinical trials. A phase III trial compares a new
way to give a treatment against the standard way.
People that participate are assigned at random to
either the new treatment or the current standard
Phase IV clinical trials- these
are trials conducted after a treatment has been
approved. The goal of these trials is to learn more
details about that treatment such as side effects,
benefits and how to optimize the use of the treatment.
What happens in a clinical
Treatment is carried out by the doctor according
to a protocol. A protocol is a plan, or sort of
a road map that the doctor follows. Each doctor
that treats participants in a study uses the same
protocol or plan. The participant's course of treatment
is followed very closely. Once the treatment portion
of the protocol is complete, participants may continue
to be monitored for other endpoints of the study.
Clinical trials have steps built
in to protect participants. One of these steps is
the informed consent process.
Informed Consent- is an
ongoing process during the course of a trial. The
doctor and study coordinator reviews the treatment
plan, which includes the potential risks, benefits
and all the detailed information about the study
with the potential participant. This information
is also written in a consent form document, which
is presented to the person before any treatment
can begin. The potential participant is given time
to have all questions answered and understand the
treatment plan. A person may choose not to participate
in a study and this does not affect their care.
If a person decides to participate, the consent
form is signed. Signing a consent form does not
mean that a person must remain in a study nor are
the person's legal rights affected. A person can
leave a study at any time without fear of penalty
or loss of any medical care. If a person decides
to leave a study the doctor will discuss information
about other treatment options.
Another step that protects patients
in clinical trials is the eligibility criteria.
Eligibility Criteria- these
are certain characteristics outlined in the protocol
that all participants in the study must have. The
criteria differs, depending on what questions the
study is trying to answer. Examples are age, gender,
type and stage of disease.
Participants' Rights- it
is important to remember that participation in a
clinical trial is voluntary. The rights of a participant
do not change because they take part in a research
If you have any questions
about participating in a clinical research study
please contact an Akron General Medical Center research