Accessibility of clinical study reports supporting medicine approvals: a cross-sectional evaluation

Clinical study reports (CSRs) are highly detailed documents that play a pivotal role in medicine approval processes. Though not historically publicly available, in recent years major entities including the European Medicines Agency (EMA), Health Canada, and the U.S Food& Drug Administration (FDA) have highlighted the importance of CSR accessibility. The primary objective herein was to determine the proportion of CSRs that support medicine approvals available for public download as well as the proportion eligible for independent researcher request via the study sponsor.
Source: Journal of Clinical Epidemiology - Category: Epidemiology Authors: Tags: Original Article Source Type: research