Home > Medical issues > What Is a Clinical Trial?

What Is a Clinical Trial?

Image courtesy stockimages@http://www.freedigitalphotos.netI’m sure many people have wondered how research is done into the identification and treatment of various diseases.  One way this is done is through a clinical trial.  This involves selecting persons who have a particular health concern, who volunteer to submit themselves to various tests and forms of treatment (drugs, diagnostic tests, devices, therapy protocols, etc.).  These test subjects agree to allow researchers to study how they react to these tests and treatments, to determine their safety and their effectiveness.

Scientists who are conducting a clinical trial will recruit study participants who have a particular set of characteristics.  For example, they may look for persons in a certain age group, sex, level of education, whether or not they have a particular health concern, and so on.  Those participating in the study will typically not receive payment, although they might be reimbursed for some expenses (such as travel).  Various forms of data will be collected by the researchers, that may include such things as blood pressure or other vital signs, how much of a particular drug is in the person’s blood, whether the person has memory problems, and other areas pertaining to what is being studied.

Sometimes researchers may compare how various groups of people perform on a particular set of measurements.  Or they may administer a series of treatments to a carefully selected test group, evaluating their performance before and after treatment, to see if there is any measurable improvement.  (Typically, a study of this kind will include a “control group,” which has not received the treatment in question, as a point of further comparison with the test group.)

Here are some examples of what a clinical trial may be set up to study:

1.  Determine the safety and effectiveness of a new kind of drug, or a different dose of a drug, on a particular kind of patient

2.  Determine whether a new device is more effective for the treatment of a particular disease than a device already being used

3.  Compare the effectiveness of two or three different treatment methods that are already in current use, in the treatment of a particular disease

One way of classifying clinical trials is by designating them as either observational or interventional studies.  During an observational study, researchers do exactly what the name implies — they observe the subjects over a period of time and collect before-and-after data.  In an interventional study, the researchers actually do something to the participants — give them a medication or a treatment, for example — and then compare how they do with other participants who did not receive the treatment.  Clinical trials can also be classified depending on their purpose.  These can include prevention trials (involving vaccines or lifestyle changes, for example), screening trials (determining ways of detecting diseases or conditions), diagnostic trials (finding out more precisely whether a person has a particular disease, or what type of the disease is present), quality of life trials (usually with individuals who have a chronic or end-stage disease), and compassionate use trials (expanding access to approved treatments for persons who have health conditions for which no known treatment exists).

There is a lot more to know about clinical trials.  If you would like more information, you can find a very good discussion here.

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