CLINICAL
FAQ's
How are new drugs tested?
In compliance with government laws and
regulations, a new drug must undergo a series of
pre-clinical and clinical research studies to prove
that it is both safe for use and effective for designated
medical condition. After all phases of research
are successfully completed, a new drug application
is submitted to the appropriate regulatory agency
for review. If that agency determines the drug or
treatment is safe and effective, it grants marketing
approval.
What is a clinical research study?
A clinical research study (or research
trial) is a supervised evaluation of an investigational
medication to determine its safety and effectiveness
as a treatment for a specific disease or condition.
Individuals enrolled in a study receive the investigational
medication, and doctors evaluate their responses(s)
to it. All clinical research studies must follow
a strict set of rules, or "protocol".
Before any study begins, its protocol must be reviewed
and approved by proper authorities and an Institutional
Review Board (IRB) or Ethics Committee (EC). An
IRB/EC is an independent committee of medical and
non-medical professionals brought together to assess
a study's potential benefits and risks to ensure
that (1) study participants are fully informed and
(2) their rights and welfare are fully protected.
What rights do clinical research study participants
have?
As a participant in a clinical research
study, you have certain rights before the study
begins and while it is in progress. You may:
- decline participation or withdraw from the
study at any time without prejudice or loss of
future treatment
- ask questions at any time about the study or
medication involved, and
You are also entitled to an explanation of any
risks, benefits and alternative treatments available
plus any significant new findings made during
the study that could affect your willingness to
continue as a participant.
What is informed consent?
Informed consent is a written agreement, signed
either by you or your designated representative,
that certifies you have been fully informed of
the nature of the research - its objectives, risks,
benefits, procedures, etc. - and are willing to
participate in the study. The agreement may not
include any wording that appears to exempt the
research physician, treatment manufacturer or
medical institution conducting the study from
the normal standard of care necessary for your
well-being. You should give your consent voluntarily
only after you have received all the necessary
information and have had sufficient time to make
your decision.
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