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Clinical research trials are a method for scientifically testing the efficacy or other factors of some treatment. Very often people think of these trials as testing new medications, but they are not limited to drug testing and might be used to examine a variety of medical therapies for very different reasons. Sometimes trials compare current treatments, look for side effects from long-term use, determine if two treatments can be safely used together, and the list goes on in an extensive fashion.
Usually, clinical research trials are the first time that humans are asked to participate in studies. Human involvement means a certain degree of safety has to be assured to participants, though a few initial trials have not always been safe. Testing the proposed therapy with other means first suggests that it will not be harmful under the majority of circumstances. Once this early testing and measurement for safety is completed, researchers devise hypotheses about what they think a treatment will do, and then determine how and on whom to test it.
Many of these trials are strictly controlled, and researchers determine in advance the population on which they’d like to test things. They might limit trials to people with specific health, age, gender, weight and presence of or lack of certain pre-existing conditions. In some instances a person must have a certain condition to participate in a clinical research trial because the questions researchers want answered are how a particular therapy would affect a specific disease. Though people needed for some research must be the picture of health, others may need to very sick to qualify for trial participation.
In a number of clinical research trials, especially in drug research, type of trial is separated into phases zero through four. Zeros are very limited, subjecting people to extremely small amounts of medicine. Phase I trials are early in the game too, still concerned with safety, dosage, and things like drug half-life. In later phases, testing gets more advanced, a trial doesn’t have to take place in one center but might be conducted by multiple researchers, and in very late trials, more tests are applied to treatments that may already be available to the public.
Early types of clinical research trials are often done on the behest of regulating agencies. People who create a new treatment must prove many things about it before it can be considered for market use. Conducting this research can take significant time, which is why it can seem to take quite a while before a new drug or device discovery is available. On the other hand, when treatments for a present condition are few, participating in a trial may be one way to get access to newer treatments. It should be noted that a lot of research is double blind with placebo; people participating may not get the new treatment and might get something else instead.
There are many questions clinical research trials may try to answer, and some of these are the most basic ones that can be asked in human medicine. When people’s distant ancestors looked to the herbs for remedies, they might have had several question in mind, including, “Is it safe?” “Will it work?” “How much do I need to use?” and “Can I use it for something else?” The scientific method has perfected ways to more reliably address these questions, and clinical research continues to ask them and look for answers via its studies.