What are Clinical Trials?

health wellness

New medical treatments and pharmaceuticals are constantly entering the market. Most of these are developed using clinical trials. Clinical trials are scientific studies using human volunteers, usually to test a product or treatment. They can help determine whether a specific therapy is safe and whether it is effective for treating a specific condition. Clinical trials are vital tools in finding new, effective medical treatments.

Clinical trials are the backbone of many new therapies, particularly cancer treatments. St. Jude's Children's Research Hospital in Memphis, Tennessee is constantly conducting clinical trials to test cancer therapies on patients – many of whom have no other hope of a cure.

Most clinical trials have specific inclusion/exclusion criteria that varies from trial to trial. For instance, a clinical trial on an obesity drug might specify participants who have not had weight-loss surgery or those who have not had prescription weight-loss medication in a particular period of time. This ensures that rogue circumstances are not at work, possibly affecting the trial's outcome.

Clinical trials may be conducted in different ways. Some use a control group that is given a placebo medication or the standard treatment for a disease, and the results are compared against those who receive the experimental treatment. Some use a double blind process, in which neither the researchers nor the patients know which group is receiving the treatment or a placebo.

A patient volunteering for clinical trials may experience unpleasant side effects and may have to go to the doctor more often than usual for evaluation. These factors are two disadvantages of clinical trials, but many volunteers are willing to risk these side effects for the chance of a cure. Participants may leave the clinical trials at any time – although they may be asked why they are dropping out of the study.

Clinical trials are usually conducted in three phases before the drug tested receives Food and Drug Administration (FDA) approval. Phase I is the first and smallest study. Phase I clinical trials use groups numbering between 20 and 80 to test the effectiveness and optimal dosage of a drug and to identify side effects. Phase II uses groups of between 100 and 300 people to further test the safety of the drug and to make more notes on its effectiveness. Phase III compares the treatment to commonly used treatments and evaluates it further for safety and dosage ranges. When a drug receives FDA approval, it goes through a Phase IV trial that helps determine its risks and benefits.

Clinical trials are usually conducted at research institutes and hospitals. One can obtain more information on the location and purpose of specific clinical trials by checking ClinicalTrials.gov.

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