Whether you are interested in possibly participating in a clinical trial or you are interested in staying informed about new treatments to manage a condition, it is important to understand how clinical trials work and their terminology.
According to ClinicalTrials.gov, there are 378,460 research studies being conducted in all 50 states and in 220 countries. Clinical trials test a new drug, therapy, surgical procedure, medical device, nutrition and even behavioral changes in people in full compliance and under ideal conditions.
People that participate in a clinical trial help researchers determine if a new treatment is safe and effective in people. The study observes if the new drug, new medical device, or for example a new diet, has better outcomes or has less harmful side effects in people compared to the standard mode of treatment.
Some clincial trials are used to test ways to detect a disease early, and others test ways to solve a health problem. Clinical trials may also explore ways to improve the quality of life for people living with a chronic or life threatening health condition.
People who participate in clinical trials join for several reasons. Most people are looking for a better outcome compared to their current treatment program, or there is no treatment for their disease. They often learn about new treatments before the public does. Other people who are healthy join trials to support the research to prevent a disease, perhaps one that runs in their family.
Clinical trials are comprised of four phases and after success in the first three phases, then the U.S. Food and Drug Administration (FDA) approves it for clinical use and monitors its results.
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According to the National Institutes of Health (NIH), Phase I of a clinical trial tests an experimental treatment on a small group of people, usually 20 to 80, to access how it affects the human body, view the side effects and determine the safe drug dosage. All patients are compliant in drug dosage and there are no other illnesses or other drugs that interfere with the outcome of efficacy.
More people (100 to 300) are needed in a Phase II trial to evaluate the treatment effectiveness to see how well it works on the human body. Preliminary data is gathered about the people and their conditions that respond to the treatment. Safety evaluations are ongoing and this phase can last several years.
Building on this, a Phase III trial is based on a larger population of people (several hundred to about 3,000) and gathers more information about safety and effectiveness, such as the drug dosage and its effects in combination with other drugs. It compares a new treatment with the current standard of care. If the trial results are favorable, the FDA will approve the experimental drug or device for use.
When the drug or device is approved by the FDA, then a Phase IV trial includes several thousand diverse people and continues to monitor the effectiveness and its side effects over a longer period of time.
All clinical trials are prospective studies in which individuals are exposed to treatment (or not) and followed for a clearly defined outcome (or a few different outcomes), such as showing resolution of disease, increased survival rate, and improvement in quality-of-life.
You can find a clinical trial by visiting ClinicalTrials.gov and of course talk to your doctor. From there, you contact the study coordinator and go through a screening to see if you meet the criteria as a participant. You will be provided with information about what to expect, how long the study lasts, what happens when the clinical trial ends, and how to be kept informed of the results.
Whatever the reason to participate in a clinical trial, your contribution helps future generations lead better lives.
