Conduct of clinical trials &
Postmarketing Commitments

Our scientists are leveraging the latest technologies and scientific advances to discover and develop new medicines.

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.

Finding better solutions to the toughest challenges
 Within each of our therapeutic areas, we have various products in development. Our core areas of research are: Immunology
Oncology
Neuroscience
Virology
General Medicine
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.

The clinical development process
 The clinical development process is divided into phases that help us learn important information in a step wise fashion. Depending on the drug and disease being studied, the process might begin with a single dose in healthy volunteers. For other disease states such as cancer, the studies may start with patients and allow dosing for as long as the patient is getting benefit from the drug. There is not a single method that can be used for all drugs and diseases. However, there are some general steps that are important for the development of all drugs depending on the trial participants and the aspects of the drug being assessed. Clinical trials can take place prior to the approval of a drug (premarket) and after the approval of a drug (postmarket).