|
Clinical trial is the scientific term for a test or
study of a drug or medical device in people. These are
done to test whether new products are safe and work
against disease. Some treatments that are being tested
have side effects that can be unpleasant, serious or
even life-threatening. Because the treatments being
studied are new, doctors don’t always know what the side
effects will be. Many side effects are temporary and go
away when the treatment is stopped. But others can be
permanent. Some side effects appear during treatment,
while others may not show up until after the treatment
is over. The risks depend on the treatment being studied
and all known risks should be fully explained to
volunteers by the researchers.
Behind every new medicine are the volunteers who take
part in clinical research studies. Practitioners of
clinical trials have a responsibility to ensure that
patients’ participation in research be informed and
voluntary. They monitor studies to help make sure that
there is the least possible risk to volunteers and that
the risks are reasonable in relation to the expected
benefits. Food and Drug Administration (FDA) sets the
rules to make sure that volunteer who agree to be in the
studies are treated as safely as possible. To help
volunteers decide if they want to be in a study, FDA
requires that volunteers be given complete information
about the study before they agree to take part. This is
known as informed consent. FDA requires that people
should be well informed of the purpose of the research,
how long the study will take, what will happen in the
study and which parts of the study are experimental,
possible risks or discomforts, possible benefits,
whether any medical treatments are available if
volunteer are hurt, what those treatments are, where
they can be found, and who will pay for the treatment,
volunteer rights, or if volunteer get hurt he can
withdraw from the study of anytime.
For full text of this article contact the publisher on
info@kppub.com
|
The above content is an
abstract only. For the full Article please contact:
KONGPOSH Publications Pvt. Ltd.
ICS House, C-19, Commercial Complex, SDA, Opp. IIT Gate,
New Delhi, India -110016
Tel.: 26855839, 20057149, Fax: 91-11-26855876
Email:
info@kppub.com /
fpc@vsnl.com, Website:
http://www.kppub.com |
