Most
people have questions when they are invited to take part
in a clinical trial. Here are some of the more frequently
asked questions and the answers to those questions:
Why
Can't I Choose which Treatment I Get.... What Group I'm
In?
The
purpose of not knowing what group you are in and being assigned
to a group on the basis of chance is to ensure that the
results of the study reflect only the treatment and not
other factors.
The fact that the medical staff does not know which groups
patients are in ensures that they don't subconsciously,
or consciously, make decisions about which patient should
receive which treatment based on the likelihood of a better
result. It also removes any emotional involvement on the
part of the patient, which could affect the outcome of the
study.
It gets back to the question of bias. When all those immediately
involved in the study are blinded to the treatment groups,
the risk of a biased result is virtually eliminated.
How
Can I be Sure a Study is Safe?
All
clinical studies conducted are carefully reviewed by an
Institutional Review Board. A detailed study plan is examined
by the IRB to help ensure that the study is designed properly
and that the findings are likely to benefit patients. The
committee also reviews existing information about the new
treatment to ensure that side effects are acceptable and
the potential benefits of the study outweigh the potential
risks.
Only those studies the IRB has approved will be conducted.
The risks and benefits of the study are in detail, in the
consent form.
Who
Conducts These Clinical Trials?
The
principal investigator has overall responsibility for the
study and plays a major role in conducting and planning
how the study will run. The study coordinator helps the
principal investigator in running the trial.
The coordinator and principal investigator are responsible
for screening patients to be involved in the study and obtaining
their consent. The progress of a participating patient is
followed closely by the coordinator, and one of the study
physicians, and the physicians and nurses caring for the
patients on a day-to-day basis.
Does
My Own Physician Know About the Study?
Do You Need His or Her Approval?
A
patient's physician will be made aware of the study. A patient
will not be considered for the study if his or her physician
or other physicians involved in his or her care do not wish
the patient to be enrolled. The patient's physicians are
kept fully briefed by study personnel throughout the trial.
What
If I Don 't Want To Be Part Of The Study?
Your
participation is voluntary. You may decline without any
change to your medical care.
What
If I Change My Mind?
You may end your participation in the clinical trial at
any time.
