• How New Treatments & Technologies Are Approved


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    Dr. James B. Hermiller, of The Care Group at The Heart Center in Indianapolis, IN, describes new treatments on the horizon for cardiovascular disease.

    Now more than ever, people with cardiovascular disease can be assured there are effective medications, procedures and other treatments available to treat their conditions. As knowledge of cardiovascular disease has expanded, so has the ability to treat the disease. Yet the medical community is always working toward new innovations to improve patient care, especially considering cardiovascular disease is the leading cause of death in the United States, with nearly 80 million Americans estimated to have a form of the disease.

    Medication & Device Development

    There are five basic stages of development that a new treatment must pass through before approval. Click here for more information on the stages of new medicine or device development.

    Many good ideas for novel treatments don't even make it through these stages due to a variety of factors such as incomplete paperwork or lack of funding. A collaboration involving researchers, doctors, regulators and the private company that owns the patent on the medication or device determine how the trials are set up. Although clinical trials for device approval typically require enrolling fewer patients than do drug trials, this gap has been narrowing as device trials are subject to increasingly rigorous scientific standards.

    FDA Approval

    As consumers of new medicine and other types of treatment, most of us are familiar with the stage that involves approval by the U.S. Food and Drug Administration (FDA). Although you may be eager to try a new treatment, unless you participate in a clinical trial you may have to wait until the FDA approves the treatment as safe and effective. Click here for more information about the FDA approval process.

    Enrolling in a Clinical Trial

    If you are interested in trying a treatment that is in development, talk with your doctor about participating in a clinical trial. Click here for more information about clinical trials and questions you should ask before participating.