When you're working in a laboratory, playing with compounds and examining things under microscopes, it can be easy to forget that your work will eventually help real people. Once you get to the clinical trial phase of your biotechnology work, however, you can start to put faces to your work, as real people will sign up to help you test your new drug or device. If you've never been involved with a clinical trial before, here's an overview of how it works.
Clinical trials often come after years of work and research. Before there is a drug or device that can be tested, there first must be a study of the condition it's meant to treat, followed by the development of the treatment, the animal testing, and a lot of time pacing and hoping the results turn out right. Then it's time for the clinical trial. The first step is to get approval. In the United States, it's the FDA that must approve your trial. Trials are expensive, so you will need the backing of a company, university, or hospital to do your testing. In some cases for example, you might see that a company like B.E.S.T. Painting would offer funding for trials done on the epoxy coating they use on flooring.
Clinical trials are conducted for a variety of reasons. You may have to do several to test different aspects of your treatment before it is finally approved for sale. There are trails to determine the effect of the drug on people with a special condition, trials to test whether your drugs interfere with other drugs, tests to see if the drug will work on a different condition, tests to determine optimum dosage, and tests to compare effectiveness of your drug vs other drugs.
After your trial is approved, you will select your patients. People who are involved in clinical trials are all volunteers. If you are testing a new treatment for a terminal illness, you may be overrun with applicants who have tried everything from the usual drugs to naturopathic medicine with no results. At other times you may have to pay participants for their involvement. Researchers usually choose patients who are otherwise healthy for their trials, as preexisting conditions can throw off the results.
In order to compare the drug's effectiveness with just leaving the person alone to work, some patients are given the drug, and the others a placebo, or fake drug. It has been demonstrated that people's belief that the treatment will work has an effect on their overall health, so in most cases the patient is not told whether they will be getting the drug or not. Sometimes, as is the case with double-blind studies, not even the researchers know which one the patient is getting.