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Aplastic Anemia and MDS: Clinical Trials

Before new medical treatments can be offered to the general public, they are tested with clinical trials. If you have a disease with no known cure, you may want to consider participating in a Clinical Trial. Developers of new medications and treatments recruit human test subjects to participate in research before the FDA can approve a new product for distribution. Phase I of a clinical trial generally involves no more than 30 human subjects. Phase II will recruit a hundred or so patients to test for side effects. In Phase III, hundreds to thousands of patients will participate, half of whom will be chosen at random to try the new treatment and the other half will be given the accepted or standard treatment.

Participating in clinical trials is a very individual choice to be made by the patient alone after discussing the ramifications with family and health care providers. The treatment may help and may make you worse. The U.S. Department of Health and Human Services has an Office of Human Research Protections which has developed rules to protect patient safety in any clinical trial funded by the federal government. Companies seeking approval from the FDA must seek permission before initiating clinical trials. Institutional Review Boards (IRB) are committees of health professionals and ethical experts as well as lay people who monitor trials to make sure that ethics are not violated and rules are followed. Patients selected to participate in clinical trials must be educated as to the risks and possible benefits of the program prior to giving their informed consent.

Racial disparities in health status and access to care are reflected in reflected in low minority participation in clinical trials. Many researchers are striving to develop effective prevention, treatment and diagnostic protocols for diseases but have difficulty recruiting minorities. Research on this problem itself has revealed that doctors do not discuss the availability of clinical trials with their minority patients. Additionally there are problems of access, as trials are often not done in the communities where people who might benefit the most live. The strict criteria for eligibility for participation in clinical trials exclude people with co-morbidities, or more than one health problem. There is also tremendous lack of trust, especially in minority communities, because of past abuses like the Tuskegee Syphilis Study and reports of uninformed testing of members of the military service. If you are a victim of MDS or Aplastic Anemia who might be interested in participating in a clinical trial, make sure to ask your doctor about studies for which you may be eligible, in addition to researching a wealth of information from the NIH, NCI and other websites. The National Center for Complementary and Alternative Medicine (NCCAM) provides information about research into alternative clinical trials you may be a candidate for. Types of research trials include the use of herbal remedies, acupuncture, dietary changes and yoga and their possible benefits to treating or reversing disease. One study recruited candidates for shamanic healing of a chronic problem.

If you have participated in a clinical trial, please post a comment and share your experiences, positive or negative. We would love to hear from you!

Image courtesy of Gale Encyclopedia of Alternative Medicine (A Navajo medicine man in 1904. Photograph by Edward S. Curtis. The Library of Congress.)
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The Healthline Editorial team writes about the latest health news, policy, and research.