What is a clinical trial?
Clinical trials is research that is done with test subjects to perform medical research. They evaluate medical, surgical, or behavioral intervention, and are the primary way that researchers find out if a new treatment is safe and effective in the majority of people. A new treatment could involve a new drug or diet or medical device. Often, a clinical trial is used to learn if a new treatment is more effective or has less harmful side effects than the standard treatment.
Usually before the US Food and Drug Administration (FDA) approves a clinical trial, scientists perform laboratory tests and studies in animals to test a potential therapy’s safety and efficacy. If these studies show good results, the FDA then gives approval for the intervention to be tested in humans.
Importance of clinical trials
Clinical trials are essential for the development of new treatments. Clinical trials must follow a set of standards established by the FDA in order for it to be conducted, and because of this they are usually a safe way to study treatment options in humans. All studies involving humans are reviewed locally as well to ensure that subjects are treated safely, fairly, and confidentially. Our current high standards of medical care are because of the studies that have been conducted under the FDA.
Every new medicine must go through clinical trials and must show that the treatment option they are testing has favorable outcomes and is safe and effective for the population of patients they are trying to treat and/or target. In addition to testing new drugs and devices, clinical trials provide and scientific basis for healthcare professionals to advise and treat patients. Even when researchers do not obtain the outcomes they predicted, trial results can help point scientists in the correct direction.
Clinical trials for dietary supplements
Just as with drugs and medical devices, dietary supplements must follow a standard set by the FDA when going through clinical trials. This standard ensures safety for the participants and ensures that the outcomes are unbiased and reliable.
For dietary supplements, the researchers are usually trying to show an improvement in condition, fewer side effects or decreased intensity of side effects, or to help prevent the onset of disease. The goal of dietary supplements is to help fill the gaps that a good diet doesn’t provide in order to help prevent a disease or to help lessen the severity of a disease. Therefore, the goal of clinical trials is to show that the dietary supplement is working in the body the way that the researchers intended it to, without the unwanted side effects.
Overall, clinical trials provide evidence that shows that the dietary supplement is safe and effective to improve the disease or illness that it is intended to. Clinical trials provide support to the claims that are being made about disease prevention and improved quality of life.
References:
- What are clinical trials and studies. (2020) US Department of Health and Human Services. National Institute on Aging. https://www.nia.nih.gov/health/what-are-clinical-trials-and-studies. Accessed June 1, 2022.
- Novitzke, Jill M. The significance of clinical trials. (2008) Zeenat Qureshi Stroke Research Center, University of Minnesota. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3317309/. Accessed June 1, 2022.
