Understanding Clinical Trials

Every medicine we take today has been studied in a clinical trial for safety and effectiveness.  The Food and Drug Administration (FDA) reviews all clinical trial results to determine if a therapy is safe and effective before approving it.  That includes all therapies - your headache and allergy drugs, as well as the statin, PCSK9 inhibitor, and other medication you may take to manage Familial Hypercholesterolemia (FH).
 
Therapies are developed by researchers at academic and government research institutions, and pharmaceutical companies. First, they are tested in animals to understand safety risks (those are called Pre-Clinical Trials).  The next step is to study the therapies in people to be sure they are both safe and effective. That is done through Clinical Trials.  
 
We have to thank the thousands of volunteers who over many years have participated in clinical trials which resulted in the use of safe and effective drugs to treat FH and prevent heart disease.

Why Participate in an FH Clinical Trial?

Clinical trials are the most important step in developing therapies for FH patients. Without patient volunteers to participate, clinical trials are either delayed or never started. Clinical trials help us understand whether a therapy prevents disease and how they affect different groups of people.
 
People with FH are the key to advancing clinical research for FH.
 
DID YOU KNOW?
 
Patients with FH were key in the discovery and development of statins and PCSK9 inhibitors. 

Millions of lives have been saved because of a small group of people who have stepped up to participate in FH research.  
" I am proud to have taken part in clinical trials to help advance new therapies, so that I can benefit and so can my family and others living with FH."
   
      - Allison Jamison                          FH Foundation                           Patient Advocate
 
Click below to access frequently asked questions (FAQ).