Numerous medical devices, procedures, therapy and drugs for
treating illnesses that we are enjoying today are products of clinical research
trials. As the medical world advances and new diseases surface, clinical
researchers found it necessary to conduct such procedure.
Otherwise known as Interventional
studies, clinical trial is done to see if a possible treatment can be approved
for wider use in the future. This procedure is required by the Food and Drug
Administration before a product can be out in the market. Most of these
clinical trials are sponsored by pharmaceutical companies and some by medical
organizations.
According to Dr. Robert Pham of
Florida, a known clinical pharmacologist, clinical research trial is done through
human volunteers. These potential treatments though had already been introduced
to laboratory animals to test its toxicity before they can be introduced to the
volunteers.
People volunteer for clinical research
trial to help in the discovery of new medicine or they have condition
themselves which was not cured by existing treatments. Dr. Robert Pham said there
might be some risk with the study but the FDA commits itself to ensure the
safety of the participants by implementing stricter rules. The Office for Human
Research Protection of the Department of Health and Human Services was tasked
to protect the volunteers.
Anyone can be a volunteer provided that the person will be
properly educated of what he is about to go through and if he will subject
himself to such research the moment he knows about the risk that may happen.
Each volunteer
must be informed that the study’s purpose is purely for research of an unproven
drug, vaccine or medical device. The duration of the research study must also
be known to the volunteer. The protocol must be explained as to what will
happen in the process, which parts are experimental and the possible risks and
discomforts the volunteer might undergo.
Possible benefits must also be discussed to volunteers like
other treatments or procedure that might be beneficial to him other than the
research. Compensations and medical treatments must be known to volunteer if he
will be injured in the process. The volunteer must also be given the freedom to
discontinue participating in the research. The FDA has the liberty to check on
the study information having all records confidential.
Interventional
studies are cross-checked by an five-men institutional review board (IRB) that
will be composed of scientist, doctors and a non-expert. They are the ones who
approve of the clinical trials that will be done within their jurisdiction,
mostly hospitals, though it can also be done in clinics and other clinical
facilities.
Dr.
Robert Phan said that the IRB guards the welfare of each volunteer. “If they
found out that the risk of the trial is too great for the volunteer, they can
make changes in the protocol or totally disapprove the research.” added Phan.
For more
information about participating in any clinical research trial, email at
robertpham876@yahoo.com or visit http://robertpham.brandyourself.com/ or ICG UNLV
Family Medical 800 N Rainbow Blvd Suite 2531Las Vegas, Nevada.
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