Medical Writing Public Disclosure Why clinical study reports really matter
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Volume 27, Issue 2 - Public Disclosure

Why clinical study reports really matter

Abstract

Clinical study reports (CSRs) have so far served as documents for drug approval, but not as a data source for further use in research and post-regulatory decision-making. Sound post-regulatory decisions also require data other than those available in publications due to reporting bias found in literature. At present, CSRs are the only documents that are comprehensive enough to solve this problem. Developments being carried out by the EMA and journal editors towards data transparency may place CSRs as future core documents.

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