The Clinical Study Report (CSR) is arguably the most important document emerging from a clinical trial
CSRs summarize a study’s data and outcomes to facilitate the evaluation of a drug’s therapeutic effectiveness. Unlike academic journal papers, in which methodological flaws may be glossed over, the CSR provides a detailed description of the study’s design and methodology, along with tables, figures, listings, and appendices that further elucidate the data.
These reports are used to fulfill regulatory requirements, substantiate labeling information, support marketing authorization, inform the development of promotional messages for commercialization, and more.
The information on clinical investigations should be submitted in specific formats based on a specific purpose:
Full CSR
A full CSR presents a comprehensive clinical and statistical description of a sponsor’s study conduct, along with efficacy and safety data.
- These reports are required by regulatory agencies, such as the FDA or European Medicines Agency (EMA), to support product approvals and the information contained within the product label.
Abbreviated CSR
An abbreviated CSR should be used for any study that is not intended to contribute to the evaluation of efficacy or provide definitive information on clinical pharmacology.
- These are used for studies not intended to contribute to the evaluation of product effectiveness or provide definitive information on clinical pharmacology. As their name implies, abbreviated CSRs usually contain abbreviated methods and efficacy sections, though they should include a comprehensive safety section.
Synoptic CSR
Use of synoptic CSRs are appropriate for any study that is not relevant to the evaluation of efficacy or clinical pharmacology.
- These documents should provide complete safety information to allow the reviewer to evaluate safety from the study. These CSRs are used, for example, in early general phase-1 safety-tolerance studies. (However, not for specific, required toxicity studies which ordinarily should be submitted as full reports.)
Supplemental CSR
Finally, supplemental CSRs can be written to provide additional detail to a full study report. These reports do not include all sections of the full CSR and typically include instances in the text referring to the main/full CSR.
Setting your study up for success
Across each use case, a well-constructed CSR plays a vital role in therapeutic development, representing the culmination of years of planning and effort to demonstrate safety, efficacy, and therapeutic value. As regulatory bodies are examining CSRs under increasingly high levels of scrutiny, it is essential that sponsors consider CSR in the early stages of clinical trial planning.
