• Your Guide to New Treatments and Technologies

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    Dr. James B. Hermiller, The Care Group at The Heart Center, 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.

    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.

    As consumers of new medicine and other types of treatment most of us are familiar with the stage that involves approval by the 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.

    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.

  • More About Approval of New Treatments

    Additional Resources on Clinical Trials

    Additional Resources on Clinical Trials

    Comparative Effectiveness Research

    The idea of CER is that researchers and scientists gather evidence and compare surgeries, medical devices, drugs, tests, or health care services, and weigh the effectiveness, benefits, and potential harms of each of these treatment options against one another.

    How Clinical Trials Work

    Although there are many types of clinical trials, they are generally considered to be biomedical or health-related research studies in human beings that are based on a study plan called a protocol. This plan is carefully designed to safeguard the health of the participants as well as answer specific research questions.

    Questions to Ask About Medical Studies in the News

    To help you sort out the significance of new studies, here are some questions to ask.

    Questions to Ask before Participating in a Clinical Trial

    Before choosing to participate in a clinical trial, it is often helpful to talk to a physician, family members, or friends. Here are some questions you may have about joining a clinical trial.

    Stages of New Medicine or Device Development

    The five key stages of clinical trials that a novel device or medication must pass through before – and after – it reaches the market

    Types of Studies

    Studies are conducted using varying methods and are commonly classified as observational or interventional.