Clinical Trials are studies that are done to determine better methods of treating, preventing, and managing diseases as well as gaining a deeper understanding of the disease process. They are a key tool in determining if a new drug or medical device is safe and effective. Often, they find new uses for an existing drug or drug combination and their outcomes can positively impact the quality of life for many disease sufferers.
The same ethical and legal codes that govern medical practices apply to clinical trials. They are heavily regulated by the FDA, the Department of Health and Human Services, and Independant Review Boards which are assigned to every study. These regulatory bodies ensure that the rights of the participants are protected, that they are not subjected to unreasonable physical or emotional harm, and that their information remains confidential. They make sure all risks are kept to a minimum and that they are worth any potential benefits.
It is required that the study subeject is informed of any possible risks and/or benefits that may result from participation in the trial, as well as any available alternative forms of treatment. This information will be in the Informed Consent Document that a member of the study team will go over with you. Any questions you may have regarding the study should be addressed prior to signing the document. The Informed Consent Document will include:
Do not agree to take part in the study until you clearly understand the process and feel comfortable in participating. You are encouraged to consult your primary care physician, family members, or friends.
Each trial has a different set of criteria that determines if you are eligible to participate in that trial. If you are interested in a particular study, you can contact the Research Department and they can go over the criteria to determine if that study is right for you.
As a research subject, you have the right to:
A randomized trial studies the difference between more than one type of treatment or procedure. You will be assigned to a particular arm of the study purely by chance.
A control group is the standard to which others are measured. The control group is usually given a placebo, or the standard course of treatment for an illness, while the other group(s) are given the experimental treatment. Researchers measure the difference in outcome between the different groups.
A placebo is an inactive form of treatment. In clinical trials, placebos are compared to the experimental treatments to determine their effectiveness.
In a Blind study, the participant does not know whether they are part of the control group, or the expiremental group. In a Double-Blind study, neither the participant nor the researcher knows to which group the subject has been assigned.
Some things you may want to consider when deciding on whether or not to participate in a study:
Research participation is strictly voluntary. What are some reasons you should participate in research?