Thursday, May 2, 2013

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 or visit or ICG UNLV Family Medical 800 N Rainbow Blvd Suite 2531Las Vegas, Nevada. 

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