The Importance of Clinical Trials
Clinical trials are essential research tools that aim to evaluate the effectiveness of a medical approach like a new drug, supplement, diet, or medical device. They are important to determine if these new approaches are safe and work well in patients. These processes are crucial in deciding which treatments or strategies work best for specific illnesses or groups of people.(1) They usually involve different study phases, and carefully selected participants. Today we’ll address the importance of clinical trials in the health industry.
Clinical Trials in the United States
In the United States, before the Food and Drug Administration (FDA) approves the start of a clinical trial, scientists conduct laboratory tests and animal studies to assess the safety and efficacy of a potential therapy. If these studies yield positive results, the FDA grants permission for the new approach to be tested in humans.
There are different clinical trials phases to test a treatment, determine its proper dosage, and look for any possible side effects. [Include Image explaining phases] If researchers find a drug or other approach safe and effective after the initial stages, the FDA approves it for clinical use and continues monitoring its effects.(2)
Why Join a Clinical Trial?
People choose to participate in clinical trials for a variety of reasons. Some patients join a clinical trial because previous treatments for their health problems did not work. Others participate because there is no treatment for their medical condition. Participants in clinical trials may learn about new treatments before they are widely available. Some studies are designed for, or include healthy people in order to find ways to prevent diseases that runs in their family.(3)
How do Researchers Decide Who Will Participate?
After consenting to participate, the patient is screened by clinical staff to see if they meet the eligibility criteria for the trial or if anything would
exclude the person from participating. Age, disease stage, sex, genetic profile, family history, and even whether or not the patient has a study partner who can accompany them on future visits, are all possible inclusion criteria for a trial. Cognitive and physical tests may also be administered as part of the screening process. (4)
Clinical trials are fundamental evidence-based processes. They are important when developing a new health product or approach as they widen the picture of a treatment’s effectiveness and possible side effects. They can show researchers what does and doesn’t work in humans that cannot be learned in the laboratory or in animals. Furthermore, people participating in different clinical trials benefit as they gain greater clarity regarding the efficacy of other treatments that can help them manage their conditions. A clinical trial is where science and knowledge are applied to improve people’s quality of life.
Author: Cristian Ocampo
Editor: Pedro Calvo
References:
[1] National Institute on Aging (April, 2020), What Are Clinical Trials and Studies? Re- trieved on September 27, 2022: https://www.nia.nih.gov/health/what-are-clini- cal-trials-and-studies
[2] National Institute on Aging (April, 2020), What Are Clinical Trials and Studies? Re- trieved on September 27, 2022: https://www.nia.nih.gov/health/what-are-clini- cal-trials-and-studies
[3] National Library of Medicine (January, 2008), The significance of clinical trials. Retrieves on September 27, 2022: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3317309/#:~:tex- t=In%20addition%20to%20testing%20new,in%20referrals%20to%20clinical%20trials.
[4] National Library of Medicine (January, 2022), Designing a Clinical Study With Dietary Supplements: It’s All in the Details. Retrieved on September 27, 2022: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8804374/
