What is a Clinical Trial?
A clinical trial is designed to determine if a new
drug or treatment will work on a disease or will potentially
be of benefit to the patient. Trials allow doctors and
researchers to gain information on the benefits, side
effects, and possible applications of a new drug as
well as different combinations, doses and new indications
of existing drugs. The medical community may be able
to determine new ways to detect, diagnose, avoid, and
control clinical factors responsible for diseases.
Clinical trials have four research phases. A Phase
I study is the first use of a new drug in humans.
It is used to test for safety and side effects, and
to determine how the drug should be given. Only a limited
number of patients are accepted for participation in
Phase I trials. If the Phase I shows safety and mostly
positive results, a Phase II trial is initiated
to investigate the ideal dosing range of the drug. The
therapy is tested in a larger number of patients to
determine how well it works, and other possible side
effects. In a Phase III trial, treatments are
compared to common or standard therapies. Patients who
participate in Phase III trials are randomized to receive
the trial drug and/or standard therapy. A much larger
group of patients is involved in Phase III studies.
A Phase IV clinical trial may be conducted to
continue to evaluate for the safety and efficacy of
cancer therapies that are FDA approved and available
for general use. Not all Clinical Trials have Phase
IV studies.
Clinical trials are regulated by a number of governing
groups and processes to help protect patient safety
and the ethicality of scientific research. Each patient
must have the pros and cons of the clinical trial explained.
Each patient MUST sign an Informed Consent form. This
form is designed to inform you as a patient and to help
communication between you and the research team. After
talking with family, friends and doctors, it is up to
you the patient to decide if you want to participate.
If you do decide to participate then you will be asked
to sign an Informed Consent form, but do not sign the
form until you know all of the risks of the particular
clinical trial. Periodically, the research team will
go over the form again with you and make sure you still
want to participate. They will continually monitor your
health to note how the treatments are affecting you.
PLEASE REMEMBER, YOU ARE FREE TO STOP YOUR PARTICIPATION
IN A CLINICAL TRIAL AT ANY TIME AND FOR ANY REASON.
Don't forget to ask questions:
