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Clinical Trials Demystified 

By Michael Plontz
(Page 2 of 2)

As one can imagine the government regulates every facet of these trials with strict guidelines. Every single clinical trial in the U.S. is approved and monitored by an Institutional Review Board (IRB) to make sure that potential benefits far outweigh the risks involved. An IRB is made up of a committee of physicians, community advocates, statisticians, and others to ensure that patientsí rights are protected and that the trial is ethical.

In addition to government watchdogs as a check and balance, informed consent must be given by any and all participants. This would include:

Why is the research being conducted
What is the desired end result
What will the trial entail and how long will it last
What are the risks
What are the benefits
Are there other treatments available
May I leave the trial at any time (the answer here is absolutely)

Age, current medical condition, type of disease being treated, and medical history will factor into the equation also. Participants must qualify before they can join a study. Many times researcher will want perfectly healthy volunteers while, in other instances, they will want volunteers with a specific disease. Inclusion criteria are factors that allow one to participate in a study while exclusion factors prevent that from happening. Once the study is set up and the participants are chosen, the clinical trial resembles any other experiment using a control group and either a blind or double-blind study.

Clinical trials with human volunteers as subjects are always necessary before a drug can be released and approved for use. Great strides have been made in many different areas of medicine including multiple sclerosis, Parkinsonís disease, cancer and Alzheimerís and HIV and AIDS research. Participation in these studies helps make it possible for many people to live or lead a better life and allows the safe release of new treatments and cures for many diseases to become available.

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