Study of information submitted by drug companies to licensing authorities

Abstract

Reports of clinical trials included in applications submitted by drug companies to licensing authorities in Finland and Sweden in four different years were studied. Many reports were submitted, but most of the trials were uncontrolled and of poor quality. Many of the reports were unpublished, and thus, as the submissions are secret, were not available to doctors. These unpublished reports were in most respects as valuable as the published reports. Most of the reports included some information about adverse effects; the information was often deficient, but skilled analysis might increase its value. This study provides support for those who want to see public disclosure of the reports of trials submitted in licensing applications.