Clinical Research Trials
About the I.M.P.A.C.T. Clinical Studies CSL Behring has sponsored two studies. Both have used human C1-INH concentrate to treat acute attacks of HAE, which has been used to treat HAE patients in Europe for more than two decades. About Clinical Research Trials Clinical research trial volunteers play a critical role in determining whether new drugs are safe and effective. Types of Clinical Research Trials Before clinical research trials begin, they must first undergo preclinical testing. If the preclinicals are successful, trials are conducted in three or more phases. Enrolling in a Clinical Research Trial Why participate in a clinical research trial? What to Expect When You Volunteer Each clinical trial is unique, but the first step is to learn as much as you can about the study and to see if you are eligible to participate in the study. Questions to Ask the Study Team Each clinical research trial study has its own protocols and medications. Learn as much as you can about any research trial you are considering. Your Rights in a Clinical Research Trial Safeguards to protect a participant's rights and safety when participating in a clinical research trial. Informed Consent Understanding your role in the clinical research trial and signing an informed consent form are a required part of every clinical research trial enrollment. However, this is not a contract, and, if necessary, you can withdraw from the study. Your Responsibilities in a Clinical Research Trial A clinical research trial investigation must comply with a specific plan or protocol. In order to meet its objectives, the study team will outline its expectations regarding your role and responsibility in the process. This ensures that the data meets rigorous scientific requirements.

I am a 63-year-old male who has had HAE for 41 years. I swell about once a week. I would like to know at what stage C1-INH testing is in America.

Each clinical trial follows a carefully controlled protocol (or study plan) that details what researchers will do in the study. You can learn about the details of each clinical trial and know exactly what to expect before you make a decision about participation.

Raising twin girls can be a challenging experience for any parent, but Joyce Wilmot of Suwanee lives
with the threat of a rare condition As often as once a week, Melissa is stricken by sudden attacks of hereditary angioedema. Read Melissa's story. Susan found that participation in clinical research trials improved her quality of life. Carl had to rely on narcotics for pain control. Then he joined a clinical research trial. In spite of HAE attacks that began in childhood, Mary's HAE was not diagnosed until she was in her 40s.
Last Modified Date: 6/22/2009 3:55 PM
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