Clinical Trials

A critical component of developing medicines is clinical research. This involves conducting clinical trials in humans to evaluate the safety and efficacy of investigational medications. Sometimes these studies include healthy volunteers but most of the studies are conducted in patients with the diseases we are studying.

The Therapeutic Goods Administration (TGA), and authorities in other countries such as the European Medicines Agency (EMA), the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan, and the U.S. Food and Drug Administration (FDA), use the data gathered in these trials to determine whether or not to approve the medication for use in their countries. To ensure these studies are conducted to the highest standards of protection for individuals who participate in the studies, AbbVie strictly follows important rules governing clinical research. These include the World Medical Association’s (WMA) Declaration of Helsinki, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and all applicable local rules and regulatory requirements.