Clinical trials make headlines so often they might be taken for granted.  Most readers know that trials represent research involving drugs or medical devices but most people don’t understand exactly how much work and detail go into one.  A recent study explores the connection between depression and chocolate but it was much more complicated than giving people a candy bar and recording how big the smile on their faces.

Clinical trials represent the application of the scientific method of research to gain a better understanding of how the human body works.  The scientific method starts with a hypothesis, or theory of how the object of the study (chocolate, for example) is likely to interact with the human.

The object of study is then administered to a group of individuals of shared experience and a uniform set of data is collected and carefully analyzed throughout the trial period.  Observational evaluations are also documented.  Once the trial is over, the data are analyzed and a conclusion is reached.  The object of study is more often a drug or medical device than candy but the same exacting protocol, or scientific criteria, is used for them all.  All study participants must be similar in appropriate ways; age, gender, lifestyle, and medical diagnosis are just a few similarities frequently used.  All participants must agree to strict compliance with the demands of the study, too, to eliminate as many variations of outcome as possible.

Once participants are selected, the difference begins.  The study group is usually divided into two or more subgroups.  One group, the control group, continues life as usual although with a great deal of laboratory and observational analysis being done along the way.  This group establishes what would happen if the object of study were not used.

The second group takes the drug in question or uses the medical device under strictly regimented conditions, such as dosage or schedule, and the results of that experience are weighed against the experiences of the control group.  Analysis after the study reveals whether or not the subjects of the test group fared better as a result of the study than did the control group.  If so, the hypothesis was proven and further studies are developed to refine patient interaction with the object of study or an application to market the product is made to the US Food and Drug Administration (FDA).

Sometimes clinical trials involve more than two groups, with dosage or scheduling variations defining each group.  Sometimes there is a placebo group, where the study participants think they are getting the medication being studied but they are actually taking a fake, or inactive, tablet or pill containing no drugs at all.  These studies document the placebo effect, or how people respond biologically when they think they are taking medicine.

This very brief description of clinical trials covers just one step of the process from development to licensing.  There are many trials along the way, each one getting more exacting as the process evolves.  Once a drug or device is submitted to the FDA for approval, it’s quite likely even more clinical trials will be conducted before a final decision is made.

In the constant quest to improve patient outcomes, clinical trials are being conducted all around the world every single day.  Depression isn’t the only subject of study, either.  Trials are under way for medical maladies that range from Alzheimer’s disease to migraines, to insomnia, fibromyalgia, and shingles, to name just a few.  They aren’t always as tasty as clinical trials that involve chocolate but they are equally important.