Clinical Study Reports-a systematic review with thematic synthesis: Part 2. Studying benefits, harms, and the benefit to harm balance of pharmacological interventions.

ABSTRACT:

Background

We define clinical study reports (CSRs) as standardized full reports of the protocols, results, and other pertinent details of clinical studies that are typically submitted by pharmaceutical companies to regulatory authorities when they apply for marketing authorization.

Methods

In this systematic review we searched various databases (Clarivate Web of Science, EMBASE and Ovid Medline, Google Scholar, and PubMed) for publications containing the term "clinical study report/s", without restrictions.

Thematic synthesis

In the first part of this review we discussed the history of CSRs, their contents and structure, definitions, and relevant terminology. In this second part we discuss the uses of CSRs, concentrating on the individual benefits and harms of pharmac

SUBMITTER: Aronson JK 

PROVIDER: S-EPMC12044985 | biostudies-literature | 2025 May

REPOSITORIES: biostudies-literature