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HOW IS MY HEALTH PROTECTED IF I AM IN A CLINICAL RESEARCH STUDY?
INVESTIGATIONAL DRUGS ARE TESTED IN THE LABORATORY BEFORE USING THEM IN HUMANS
Many laboratory tests are done over several years to see how the investigational drug works in test tubes and in animals. All of this information must be submitted to the Food and Drug Administration (FDA). The FDA will review it and decide whether the drug is safe enough to be tested in humans. Only 5 in 5000 investigational drugs tested in the laboratory will ever be given to a subject in a clinical study.
YOUR HEALTH IS OUR #1 PRIORITY
Whether or not you are in a clinical research study, your health is the priority here at Slocum-Dickson Medical Group. If you are a subject on a clinical research study, we are particularly interested in any side effects or health problems you have. You should always follow the instructions you are given about how to report side effects so that they can be treated if necessary. In many research studies, you will be asked to come back to the doctor’s office more frequently than if you were not in a study. This is done so your progress in the study can be watched carefully and so any side effects are brought to your doctor’s attention promptly
RISKS AND BENEFITS
As part of the informed consent process, the risks and benefits of a particular clinical research study will be discussed with you. In order for you to make the best decision about whether or not to be in a clinical research study, you must understand the risks and benefits. The informed consent form should list the side effects of the investigational drug. If the informed consent form does not tell you how many patients experienced those side effects, you might want to ask about that. Usually, this number is given as a percentage of patients who experienced a certain side effect. Making a chart like the one below might help you see how much of a risk is involved with a particular investigational drug. The process of assigning a subject to one of the groups on the study. When a study is “randomized”, it means this assignment is done by a method similar to flipping a coin. In other words, neither you nor your doctor get to choose what group you will be in.
Side Effect |
% of subjects who had this side effect when taking Investigational Drug A |
% of subjects who had this side effect when taking placebo |
Total number of subjects |
5200 |
5200 |
Headache |
10 |
9 |
Rash |
4 |
12 |
Constipation |
25 |
10 |
First, check how many subjects have taken the investigational drug. The more subjects who have taken it, the more likely that the side effect percentages are accurate. Next, compare the frequency of each side effect between the groups of subjects.
From the chart above, you can see that 10% of patients who took Investigational Drug A got a headache. This means that for every 100 people who took Investigational Drug A, 10 of them got a headache. When you compare this to the percentage who got headaches after taking placebo (9%), you will see that those two numbers are very close. If the numbers are close, then that side effect was probably not caused by Investigational Drug A.
On the other hand, if the numbers are not close to each other, it is likely that the reason is because there is a difference between Investigational Drug A and the placebo. In the example above, it appears that Investigational Drug A might help prevent rash, because fewer people got a rash while taking it than if they were taking placebo. Also from the example above, it appears that Investigational Drug A does cause more people to feel constipated than the placebo.
In order to decide if a study is right for you, you should carefully weigh the risks and enefits. Only you can decide if the study is right for you.
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