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Welcome to Optimum Clinical Research. We are a research company that helps bring safe, effective new medicines to the public through the use of clinical research studies. We are located in Salt Lake City, Utah. Clinical research is ingrained into modern medicine, but the majority of the population knows little or nothing about this vehicle that brings medicines to market. So what exactly is clinical research? Well, whether you live in New York City or Salt Lake City, clinical trials seek to ascertain the safety and efficacy of a drug or other treatment. The Food and Drug Administration (FDA) is responsible for the modern structure of clinical trials. Safety is fairly straightforward, the FDA wants to ensure that all drugs coming to market are safe for us to use. Efficacy is the term used to denote how effective a drug is. So in order to be brought to market a drug has to be both safe to use, and demonstrably effective in treating a disease or symptom.

So how does one go about determining the safety and efficacy of a drug? The FDA has set out a series of four phases of clinical trials that a drug should go through. The first three phases (I-III) are the pre-market trials, while the fourth phase (IV) takes place after approval has been granted. Each phase of clinical research emphasizes a different aspect of the drug’s effects.

The intended effect of the drug is of course an important aspect of the process, but throughout its effectiveness is secondary to its safety. The diet drug fen-phen (or fenfluramine and phentermine) is a perfect example of why this should be the case. The drug was wonderful at causing people to lose weight. Unfortunately it also had the unintended side effect of major heart problems. The initial testing had underestimated the chance of heart problems, and the phase IV test was never performed for the drug. This study could have caught the adverse side effects much sooner than they were discovered on their own.

In a phase I clinical trial, a small group (usually less than 100) of healthy individuals are selected to receive the drug. Phase I is the first stage of human testing, but it cannot occur without years of research and testing before it. The people in phase I do not have the condition a drug is trying to treat, they are simply testing to see if there are any unpleasant side effects to the drug.

If a drug passes phase I, the pool is opened to a larger group (but still less than 300 in most studies) who actually have the disease. For example, if you wanted to test a diabetes control medication for type 2 diabetes, you would seek volunteers who were in the early to middling stages of the disease. The reason you would stay away from advanced stages is because late diabetes comes with a host of other health problems, and the second phase focuses more on efficacy than the first or third phases do.

It is by no means guaranteed that a drug passes any given phase. In fact 70% or more of drugs that are researched never reach phase III testing in clinical trials. In phase III a drug’s study group is enlarged yet again, sometimes numbering as many as 3000 in any given study. The group is also broadened to people who have other conditions than the main disease or symptom the drug is intended to treat. They are often taking other medications, over the counter or prescription. The third phase continues to test for efficacy, but it is also looking for interactions with other drugs. If a drug successfully passes phase III testing, it is considered suitable to market, but that isn’t the end of the research cycle.

A large scale post-market study can be undertaken, often including tens of thousands of people who are proscribed the drug. The so called phase IV study checks to make sure that the drug is indeed safe and effective across a much broader portion of the population. It can also test for long term side effects from the drug. Phases I-III last anywhere from six months to two years, which is not long enough to accurately determine the effects of taking the drug for a long period of time. The phase IV study seeks to do just that.