Clinical Trials are research studies which are required to test new medications before they are approved by the FDA (Food and Drug Administration). Only after this approval are new medications made available by prescription by a licensed physician. A large number of studies have to be completed to demonstrate the safety and effectiveness of new medications. The FDA has specific requirements on how the studies are designed and conducted to prove the information in a scientific and ethical manner. Each individual trial has to be submitted to the FDA before it is allowed to begin. Many of these trials are listed on the government’s website: www.ClinicalTrials.gov.
Participating in a clinical trial is a research study and must not be considered a treatment for a specific illness or condition. The medical evaluation (blood tests, physical examinations, study medications, etc.) is part of the research study and does not substitute for the medical care provided by your family physician or healthcare provider.
Before participating in a research study, you must understand and consent to participate
in that clinical trial. The consent process begins with reading of the consent form. Typically the development of the consent form is a collaborative effort of the research site, the IRB (Institutional Review Board), and the pharmaceutical company sponsoring the research study. The IRB is an independent organization that has the responsibility to approve the consent form and oversee the safety of the patients while they are participating in the research study. After the consent form is read, it should be discussed with the physician conducting the research study or a member of the research team. At that point, one could sign the consent form and begin the study. However, that is not the only option. A prospective volunteer does not have to begin the study at that time. For example, one could take the consent form home to think about the study, or one could discuss it with his/her family physician, spouse, friend, etc. prior to deciding whether or not to participate in the study. Even after signing the consent form, the research participant should always feel free to ask questions at any time throughout the study. Also, the research volunteer can quit the study at any time without consequences, if he chooses not to continue in the study.
As a research participant, it is very important that you be honest regarding your medical information with the research staff since this could affect your health and safety while participating in the research study. Attending the scheduled visits and taking the study medications as prescribed is very important. Reporting any changes in you health, any changes in your use of medications (both prescription and over-the-counter), or changes in your use of vitamins, or supplements at each visit is an important part of the research process.
As a volunteer in a clinical trial you may experience risks as part of the research study. It is very important that you understand these risks when you are deciding to participate in a research study. Typically, there are risks associated with the study medication(s), the procedures required for research study, and the possibility of receiving a placebo. A placebo is a pill that has no active ingredient in it. This means that the medical condition that is being studied would be untreated for the length of time of the study. There may be other risks which could occur that not anticipated. These important issues should be discussed with the research doctor. If you do not feel comfortable regarding the possible risks of a research study, you should decide not to participate in that study.
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