Whether it's called a clinical study or clinical protocol, it's basically the same thing. It's a controlled experiment to see how new medications work in people. Before doctors can prescribe them it must be proven that these treatments are safe in humans, and this testing is only allowed in volunteers if they willingly participate in a study and understand the risks involved. Clinical trials take place in hospitals, community clinics, and universities. Volunteers receive informed consent documents detailing exactly what goes on during the study.
Types of Volunteers Recruited for Clinical Studies
Clinical trials vary considerably. Some of them look for healthy participants while others seek volunteers with a pre-existing illness. These studies can also recruit people who fall into a specific age bracket or a particular ethnic group. Regardless of who the volunteers are, every one of them needs to complete, and pass, a medical screening.
The staff will ask volunteers specific questions about medical history and perform numerous tests to weed out unsuitable candidates. Height and weight will be measured. Some studies call for overweight volunteers but the majority of them do not. Blood and urine samples must be provided to the staff in order for them to see if anyone is sick or taking drugs of any kind. If a volunteer passes all of the tests and there are no problems, that person will be told what time to show up at the study location. Clinical trials include people of various ages and nationalities.
What Happens During a Clinical Study?
If the study lasts for several days or more than a week, volunteers may be asked to stay that entire length of time within the clinic. They will have all of their meals provided for them, plus a few snacks. Participants will be required to take medication according to a predetermined schedule, and the health of each volunteer will be closely monitored by the clinic personnel. Volunteers should tell one of the staff members if they are experiencing side effects, no matter how mild.
Volunteers will be subject to the rules of the study, which means they will have to take all of the medication that is given and appear for any and all blood work done by the staff. If a study lasts for several months and is separated by periods of one or two weeks, volunteers may be instructed not to take over-the-counter or prescription medications or drink caffeinated beverages when they're not in the clinic. These things could interfere with the study drug and skew the results of the trial.
After the Study is Completed
There is a washout period after every trial during which volunteers shouldn't do another study at the same clinic or at a different clinic. The minimum amount of time varies from one study to another and it also depends on the half-life of the drug. Volunteers may also be asked to undergo a physical examination upon finishing the study. Some people may wish to take iron supplements to rebuild their blood count. Green leafy vegetables, fish, beef and beans would help.
Scott Hayden - Since joining Suite101 in early 2007, I've contributed articles about travel, history and health. My speciality is writing about workplace ...
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