We have probably all heard the term “clinical trial” at one point or another. Usually it is mentioned on a commercial for medication, claiming that it’s the next best thing because it did well in said clinical trials compared to other medications (or no medication at all). But “clinical trial” is just another one of those terms that we hear as consumers and don’t fully understand what it means. Oftentimes, we feel that we can trust whatever medication or supplement is being sold because it’s tacked on in the sales pitch. In reality, clinical trials are used to study new medications, alternative practices, or different uses for already existing medications to further benefit the general public, so there is some merit to our blind trust in a term. Let’s take a look at what exactly goes into a clinical trial and why we even go through the process of having them.
Clinical Trial Vs Observational Study
To understand what a clinical trial is, we must first understand what a clinical study is. The U.S. National Library of Medicine defines a clinical study as, “involving research using human volunteers (also called participants) that is intended to add to medical knowledge.” With clinical studies, there are two kinds that may be performed: clinical trial (also called interventional studies) or observational study.
Clinical Trials – In clinical trials, participants are given specific interventions by researchers. These can be medications, changes in diet, changes in behavior, devices, etc. Researchers can compare the use of the intervention to a different medication or tool, to a placebo, or no intervention at all.
Observational Studies – In observational studies, health outcomes are studied by researchers after a research plan or protocol has been put in place. There may be intervention tools used, such as medications or procedures, but they are not specifically assigned by the researcher as a part of the study. For example, if researchers may want to study blood pressure in people over 60 and lifestyle choices, the participants may continue to use their daily medications and procedures.
Clinical studies are usually lead by researchers that are medical doctors and work with a team of other healthcare professionals and/or social workers. The funding for this research may come from private investors or government funding. According to the NLM, “Clinical studies can be sponsored, or funded, by pharmaceutical companies, academic medical centers, voluntary groups, and other organizations, in addition to Federal agencies such as the National Institutes of Health, the U.S. Department of Defense, and the U.S. Department of Veterans Affairs. Doctors, other health care providers, and other individuals can also sponsor clinical research.”
Four Phases of Clinical Trials
Talking specifically about clinical trials, there are four phases that medications, procedures, or devices go through. These phases are to find appropriate dosage, test the treatment, and look for any side-effects. Typically, the FDA requires phases one through three to determine if a drug is safe for consumers. According to the National Institute on Aging, the phases include the following:
Phase I.) A Phase I trial tests an experimental treatment on a small group of often healthy people (20 to 80) to judge its safety and side effects and to find the correct drug dosage.
Phase II.) A Phase II trial uses more people (100 to 300). While the emphasis in Phase I is on safety, the emphasis in Phase II is on effectiveness. This phase aims to obtain preliminary data on whether the drug works in people who have a certain disease or condition. These trials also continue to study safety, including short-term side effects. This phase can last several years.
Phase III.) Phase III trial gathers more information about safety and effectiveness, studying different populations and different dosages, using the drug in combination with other drugs. The number of subjects usually ranges from several hundred to about 3,000 people. If the FDA agrees that the trial results are positive, it will approve the experimental drug or device.
Phase IV.) Phase IV trial for drugs or devices takes place after the FDA approves their use. A device or drug’s effectiveness and safety are monitored in large, diverse populations. Sometimes, the side effects of a drug may not become clear until more people have taken it over a longer period of time.
Why Do We Have Clinical Trials?
While we know that clinical trials can study a variety of treatments, both new and old, for a ton of reasons to benefit us, why even go through the time, money, and effort of putting medications, procedures, and devices through a clinical trial? Because beyond the federal regulation of drugs and medical devices in the US, companies do actually want to ensure that the product that you’re using is both safe and effective! Clinical trials can also effectively highlights important information that would be relevant to consumers (i.e. those daytime TV prescription commercials that say that “87% of participants had clearer skin!”).
Revive® is a bladder support device made for women suffering from light bladder leaks related to Stress Urinary Incontinence (leaks when you laugh, sneeze, or cough). To ensure the safety and comfort of our users, the Revive® team conducted a clinical trial to assess the effectiveness of the products. The results showed that 71% of women experienced reduction in SUI symptoms with Revive, 75% of the time women felt dry while using Revive, 83% of users would recommend to others, and 90% of participants felt the product was good fit upon first use! Learn more at userevive.com, or find a retailer near you.