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 its 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. The pros and cons of a clinical trial must be explained to each patient considering enrolling in it, and each patient MUST sign an Informed Consent form. This form is designed to fully inform the patient and to faciliate communication between the patient and the research team. After talking with family, friends and doctors, it is up to the patient the decide whether to participate in the clinical trial. If the patient decides to participate, she/he is asked to sign the Informed Consent form once all the risks of the particular trial are fully understood. Periodically, the research team will go over the form again with the patient to make sure the individual still wants to continue her/his participation. The patient's health is continually monitored during the course of the treatment in the clinical trial.
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:
