Published on September 8, 2009 at 6:38 AM
It has been more than 50 years since the U.S. Food and Drug Administration (FDA) last approved a new medicine specifically for lupus – when Dwight D. Eisenhower was president. Existing treatments have been "borrowed" from other disorders and the risk/benefit ratio of these treatments is far from optimal. However, hope is on the horizon. Data from a recent study of an experimental treatment showed promising results, and approximately two dozen potential new lupus therapies are in various stages of development and evaluation.
Unfortunately, biotechnology and pharmaceutical companies are finding it increasingly difficult to recruit a sufficient number of eligible people with lupus at experienced clinical trial centers to participate in their studies. This shortage of well-informed patients threatens to slow the momentum which had been building for lupus drug development.
To address this shortage of participants, the Lupus Foundation of America (LFA) will conduct a live chat on its website, www.lupus.org, on Wednesday, September 9 at 3:00 p.m. Eastern time, to answer questions from individuals who may be interested in lupus clinical trials. Kenneth A. Getz, a senior research fellow at the Tufts Center for the Study of Drug Development, will be the featured guest. Use this link to login to the live chat or to submit a question in advance.
Getz is the founder and Board Chair of the Center for Information and Study on Clinical Research Participation (CISCRP), and author of a nationally recognized book for patients and their advocates entitled, “Informed Consent: A Guide to the Risks and Benefits of Volunteering for Clinical Trials.”
The LFA created the Center for Clinical Trials Education (CCTE) (www.lupus.org/clinicaltrials) to educate people with lupus about clinical trial participation, and to provide information they should know before making a decision whether to enroll in a study.
Approximately 1.5 million Americans have a form of lupus, a chronic autoimmune disease which develops when the immune system is unbalanced, causing it to become destructive to any organ or tissue in the body.
http://www.lupus.org/newsite/index.html