Clinical Research is a Key Component of Developing New Medicines
A critical component of our medicinal product development is clinical research. This involves conducting clinical trials in humans to evaluate the safety and efficacy of new pharmaceutical products. Sometimes these studies include healthy volunteers but most of the studies are conducted in patients with the diseases we are studying.
Local authorities, such as the European Medicines Agency (EMA), the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan, the U.S. Food and Drug Administration (FDA), as well as those in many other countries, use the data gathered in these trials to determine whether or not to approve the drug 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.
We are Committed to Good Clinical Practice
Throughout the clinical trials process, patients remain our highest priority. Good Clinical Practice (GCP) is a global ethical and scientific quality standard for designing, conducting, recording and reporting clinical trials. Compliance with this standard provides public assurance that the rights, safety and well -being of trial subjects are protected, consistent with global ethical standards and regulatory requirements. Compliance also assures the credibility of the clinical data. AbbVie is committed to ensuring Good Clinical Practice is strictly adhered to within all AbbVie-sponsored clinical trials.