The Clinical Trial Process
The Center For Information & Study on Clinical Research Participation (CISCRP) is holding educational events about the clinical research process in cities around the United States. If you're interested in learning more about the clinical trial process, read more about the CISCRP Aware for All: Clinical Research Education Day program near you.
A clinical trial is a research study intended to test the safety and effectiveness of a new device and/or medication. If you are considering participating in a clinical trial, it is important that you understand the entire process and possible risks.
Clinical trials must follow rules set by the U.S. Food and Drug Administration (FDA). Any study involving humans must be approved by an Institutional Review Board (IRB) responsible for ethical treatment of human subjects.
If you apply to be part of a clinical trial, you may not necessarily be enrolled. You should understand that if you are enrolled in a trial, you may not receive treatment. Instead, some participants in a trial will receive a “placebo” so that researchers can compare results from individuals who received treatment with those who did not receive the test product or intervention. For example, if you are involved in the clinical trial of a medication, you may receive a placebo, or inactive pill, rather than the medication in question. Also, if you receive treatment during a trial, it may not necessarily be effective. Nevertheless, clinical trial participation is important because information obtained from trials helps researchers develop new and better options for those suffering from an illness. In addition, you may want to participate in a clinical trial to gain access to expert medical care and a new treatment before it is widely available.
The information that you provide in a clinical trial will be used to answer questions about a device or medication’s safety and efficacy. If a device is proven to be more effective than the placebo, then it goes to the FDA for approval. Once approved, it is licensed for the public to use, by prescription by a licensed medical professional.
As with any trial, there are risks and side effects that may occur. These risks may be displeasing or may have a negative effect on your health. Research staff should fully explain all risks that may be involved before you begin a trial. If at any point you want to stop participating in a clinical trial, then you are free to do so. It is best to have a final check-up after participating in a clinical trial because a medication or device can still have an effect on your health. Overall, you need to ask questions and understand the process before beginning a clinical trial.
Source: From "Learn More about Dignity Study." Dignity Study. http://www.dignitystudy.com/about-dignity-study/about-dignity-study.htm, and “Industry Sponsored Clinical Trials” in Digestive Health Magazine, and “Verichip Overview.” http://www.surge-its.com/verichip/index.html.