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What are Clinical Research Studies?

Article submitted by Western States Clinical Research. If you would like more information about research and/or our studies, please contact us at 303-940-9773 or visit our website at

Denver, Colorado - Despite being on two types of inhaled medications for her asthma, Carol felt short of breath much of the day. It seemed as though the medications that worked for her just last year were not doing the job. In fact, she had to use her albuterol inhaler 3 times a day lately. She told her doctor about her increasing symptoms and the fact that she was worried about how much medicine she was using.

Luckily, her doctor was familiar with clinical research studies, also known as clinical trials. One of his colleagues happened to work as a principal investigator with a nearby clinical research site so he called him to ask if he was aware of any asthma studies enrolling. Fortunately, there was a trial for an investigational medicine to treat uncontrolled asthma.

He gave Carol the phone number of the research site where one of the staff members would screen her to see if she was an eligible candidate for that particular study. After she answered a series of questions, she was found to be eligible for the study and the study coordinator scheduled an appointment for her to come in and learn more about the study.

These are the first steps to participating in a clinical trial. Every candidate must read over a consent form which goes into detail about the risks, benefits, objectives, diagnostic testing and expectations of the study. If a person agrees to participate, he or she will sign the informed consent form. Then begins the process to see if he or she qualifies to take part in the study.

Carol found out about the study through her doctor, however, there are many other ways to learn about clinical trials. On the internet, and list research studies based on type of illness and the state in which you live. Research sites also advertise in newspapers and through radio and television.

While every study is different as far as disease studied, types of testing, and investigational medication administered, one thing remains the same - an ethical research site closely monitors their patients and does their best to ensure the safety of their volunteers during the course of the study. A volunteer can expect to receive study medication and physician exams free of charge and possibly compensation for their time and travel. The site expects compliance with study medication and tracking of symptoms, typically with some type of diary. In addition, it is important to attend scheduled visits with the site and the physician who is the principal investigator and if one cannot make it, to reschedule the appointment.

There are four phases of clinical research studies. The goal of the Phase I study is to make sure the medication is safe for human beings. These studies are done on a small population of healthy human volunteers. Phase II studies are done after the study drug has been shown to be safe in healthy human volunteers. Now the manufacturer wants to find out if the drug is effective in treating the patient's disease or medical condition. Further safety testing is done as well. In Phase III, a larger group of volunteers are enrolled and continued efficacy and safety testing is done. Finally, medications in Phase IV studies are already approved by the Food and Drug Administration but the company wants to determine the long-term effects and/or see how their drug compares against another.

It is important to note that many studies use a placebo (a substance that has no therapeutic effect) arm as well and it cannot be guaranteed a patient will receive actual study medication nor that the study medication will be effective. As it turned out, Carol received the study medication and stayed in the study for the full duration. She gained a better understanding of her condition through the close monitoring from her doctor and from the required diary she kept to track her symptoms. She found the study medication slightly helped her breathe easier based on her subjective feelings and the pulmonary function testing provided by the research site. Overall, Carol felt good about being a part of medical research and she hoped her participation in the study will help other sufferers of asthma.

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Posted December 2012 on