Clinical Study Reports-a systematic review with thematic synthesis: Part 1. History, contents and structure, definitions, and terminology.

Abstract

Background: Clinical study reports (CSRs) are standardized full reports of the protocols, results, and other pertinent details of clinical studies that are typically submitted by pharmaceutical companies to regulatory authorities, as part of the drug approval process. Their recommended contents and structure were described in 1995 in a document of the International Conference on Harmonisation, ICH E3, although companies can choose how to present the data. Until 2015, such reports were not readily available to the public, but since then some regulatory authorities have made them available, as have some pharmaceutical companies, albeit often in abbreviated or redacted versions. The apparent benefits of pharmacological interventions are not as impressive when they are calculated using data from clinical study reports compared with published trial reports, and more information emerges about harms the interventions can cause.

Results: Our methods are described in Part 2 of this systematic review with thematic synthesis, in which we have summarized the uses of CSRs, as described in 349 publications of various sorts, including analyses of clinical trials, data analyses, commentaries, and official documents. We have specifically concentrated on how CSRs affect assessments of benefits, harms, and the benefit-to-harm balance, and other factors that affect it. In Part 1, we discuss the history of the development of CSRs, their contents and structure, definitions of CSRs and qualifying terms, and relevant terminology (including the availability of CSRs, data sharing systems, and transparency and confidentiality).

Conclusions: Our conclusions are listed in Part 2 of this review.