If you’ve ever seen a commercial for a prescription medication, you’ve probably heard something along the lines of, “In clinical studies, eight out of ten people saw an improvement in [whatever ailment].” Or you might have been killing time reading posters in your doctor’s office and seen a flier for a pharmaceutical company seeking people for clinical trials, urging you to call if you meet certain criteria. But what are clinical trials, exactly, and how do you know if you should sign up for one?
First, clinical studies and clinical trials are actually two separate things. Clinical studies, or observational studies, observe participants in their normal environment and routine. For example, the study might follow a group of people over the age of 70 who do a variety of different physical activities. Some might be sedentary, some might go for a short walk every three days, and some might still be up for a daily jog. The researchers would then measure the differences in cardiovascular health according to their lifestyles. It might not even be this involved – some clinical studies are as simple as having people complete questionnaires. Clinical studies can help identify possibilities for clinical trials.
Clinical trials might look for ways to prevent a health problem or test the effectiveness of a new medication or treatment. For example, a pharmaceutical company testing out a new blood pressure medication might take that group of seniors and assign some of them placebos and some of them the medicine to see what difference it makes. That’s how you end up with “one pill a day, along with diet and exercise,” as prescribing information.
There are four stages to a clinical trial, and typically the FDA requires the first three to be passed before it determines if a drug can be approved for use. Phase I involves testing a small group of healthy people in order to determine safety and side effects. Phase II involves more people and focuses on the effectiveness of the drug. Phase III will have still more participants and try different dosages and combinations with other drugs. After FDA approval, Phase IV monitors effectiveness and safety in a large population.
How do you know if a clinical trial is for you? Make sure it’s being conducted by a reputable organization, first of all. Find out everything you can about the purpose of the research, the possible risks, and how long it will last. Depending on what’s being tested and how experimental it is, there’s always a chance that it’s dangerous, but at the same time you’ll be given the opportunity to reap the benefits before anyone else if it is effective.
In the case of people with substance abuse problems, there are clinical trials specific to addiction. These could be for anything from anti-withdrawal medications, vaccines for certain substances, therapeutic devices, and more. To find out if there are any trials taking place in your area, you can visit www.clinicaltrials.gov or use the National Institute on Drug Abuse clinical trial locator.
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