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Toms River, N.J., September 8, 2003 – The concept of clinical trials is not new, yet when asked, many people do not know exactly what a clinical trial is, or how to find information about them. With proper information, a clinical trial may be very beneficial to individuals diagnosed with certain diseases or conditions.
Clinical trials are research studies that test new medical treatments in people. The treatments can vary from a drug to a piece of equipment, a new test to disease prevention methods. Clinical trials are experiments, and their goal is to determine if a certain treatment is safe and effective. There is no guarantee a clinical trial will produce a certain or expected outcome, which is why they are undertaken on many different types of people with various forms of a condition or disease.
Before a clinical trial is begun, researchers must test their ideas in laboratory experiments. Because of this, people who participate in a clinical trial can be assured much research has been conducted before it is tested on people. Only tests that succeed in the laboratory go on to become clinical trials.
Clinical trials are required by federal law. The Food and Drug Administration (FDA) requires that companies, government agencies or health care institutions demonstrate that new medical procedures and products are safe and effective before the FDA will approve them for use in the general population.
There are many different types of clinical trials, including treatment trials, prevention trials, screening trials, diagnostic trials and genetic studies.
People interested in participating in a clinical trial can research those being conducted by talking with their physician or other health care professional, or by investigating trials being conducted by agencies such as the National Cancer Institute or the National Institutes of Health.
Through its affiliation with the Fox Chase Cancer Center, Community Medical Center’s Regional Cancer Center is currently offering two different cancer prevention studies; SELECT and STAR. SELECT (Selenium and Vitamin E Cancer Prevention Trial) is a study to prevent or reduce the risk of prostate cancer in men over age 55 and African American Men over age 50. STAR (Study of Tamoxifen and Raloxifene) is an international breast cancer prevention study for postmenopausal women.
Sponsored by the National Cancer Institute, the SELECT trial will determine if daily supplements of selenium and/or Vitamin E reduces the number of new prostate cancers diagnosed in healthy men. The trial aims to substantiate earlier separate findings suggesting these naturally occurring nutrients may prevent prostate cancer.
To participate, men must be in good general health, be 55 years or older or 50 years or older if African American, have a prostate-specific antigen (PSA) test level of less than or equal to 4.0 ng/ml, and have no other forms of cancer except non-melanoma skin cancer.
The STAR trial is also sponsored by the National Cancer Institute. It’s objective is to determine whether the osteoporosis drug raloxifene has equivalent breast cancer risk reduction benefits with reduced risk of side effects as compared with tamoxifen. Postmenopausal women age 35 and older are eligible to participate, as long as they are also in good general health and have an increased risk for breast cancer. Participants will receive either tamoxifen or raloxifene daily for five years.
Participating in a clinical trial allows one to be a partner in medical research and may reduce their own chance of getting a certain disease. Participants also have the satisfaction of helping future generations potentially become disease-free.
For more information about clinical trials, talk to your doctor. To find out more about the SELECT and STAR clinical trials offered at Community Medical Center, call (732) 557-8295.
Community Medical Center (CMC) is an affiliate of the Saint Barnabas Health Care System, the largest integrated health care delivery system in New Jersey, with nine acute care hospitals, nine nursing homes, five ambulatory care facilities, three geriatric centers, three assisted living residencies, a freestanding 100-bed inpatient psychiatric facility and a statewide behavioral health network. Located in Toms River, Community is a fully accredited, acute-care 596-bed facility offering the most advanced, ultra-modern diagnostic and treatment services, including emergency and urgent care, laser and arthroscopic surgery, maternity and a Level II special care nursery and pediatrics unit. CMC offers the Community Regional Cancer Center, affiliated with the renowned Fox Chase Cancer Center in Philadelphia; state-of-the-art Radiation Oncology; a Renal Dialysis Center; a Cardiac Catheterization Laboratory, as well as general medical and health care services to the residents of Ocean County; and the Center for Kids and Family with sites located in Toms River and Lacey. Community Medical Center has been awarded the esteemed Magnet Status for Nursing Excellence from the American Nurses Association's Credentialing Center (ANCC).
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