Confidentiality of Databases: The View of One Pharmaceutical Company

Abstract

This paper is based on experiences during several years of practice in pharmacovigilance. References to databases will be made as a user. Specific issues pertaining to confidentiality of reports from clinical trials will be not covered, as they are more related to other databases and processes which are part of clinical research. Three main areas will be described: confidentiality in regard to the patient; confidentiality inside the company, in regard to the patient and to persons associated with the company; and confidentiality outside the company, vis-a-vis the authorities, other companies, and the media.