A clinical trial, sometimes called a research study, is a study conducted by medical scientists to improve the care and treatment of patients afflicted with the same or similar disorder. Studies conducted on animals, in test tubes, or in using various other laboratory techniques are often called basic research. In the setting of human disease, clinical trials may include studies to evaluate the cause, the course, and the treatment of disease; improved ways to diagnose, prevent or alleviate treatment side effects; help to stabilize and prevent worsening or exacerbation of a condition; and improve the comfort and quality of life of persons afflicted with the condition. Measuring the beneficial effect of new therapies is often the most visible and tantalizing of the spectrum of activities that can be classified as clinical trials. When clinical trials are being performed to evaluate the safety and effectiveness or a new drug or therapy, there are very special regulations and authority. In the US, these regulations are administered by the Food and Drug Administration (FDA) and the FDA decides whether the studies performed conform to regulation and whether they have demonstrated sufficient beneficial effect on the disease and are sufficiently safe to warrant approval so the drug or therapeutic agent can be given to patients. Many patients with lymphedema and lymphatic diseases are interested in participation in clinical trials for new therapies. The best way to be sure you are notified of and are given the opportunity to participate in clinical studies is to join the upcoming National Patient Registry and Blood/ Tissue Bank. In general, a therapeutic treatment or drug can be tested in humans only after its safety and effectiveness have been demonstrated in a variety of animals. Even the start of animal trials must be preceded by a significant amount of work to find the correct dosing form and effect in the test tube and lab. Once human trials start there are three phases of testing that must be done: Phase I trials are small studies that represent the first administration of a new drug or therapy to humans, sometimes done on healthy volunteers. The main purpose of a Phase I study is to evaluate whether the treatment is safe. These studies often start by administering very low doses of the drug or treatment, then gradually work up to the full dose expected to be used when given to patients. Phase II studies often represent the first time a drug is administered to patients who might actually receive the drug or therapy, if it is approved. In this phase of development, the drug or therapy is evaluated in a slightly larger group of subjects and again there is close attention paid to safety. Often a Phase II study will try to identify the best dose to treat patients. Phase III trials, often called pivotal trials, provide for the new drug or treatment to be tested in a large number of patients at the dose that is expected to be used once the therapeutic agent is approved. A Phase III trial compares the drug or therapy either to current accepted therapy or to a placebo. A placebo is a medication designed to look like the study drug but with no activity (often called a "sugar pill").

The Lymphatic Research Foundation does not provide medical or other healthcare opinions or services. The enclosure of another organization's hospital's resource(s) does not indicate or imply that LRF endorses, recommends, or favors the enclosed information.

No links currently available.