Clinical Study Reports

What is a Clinical Study Report?

Clinical Study Report is a document that describes the methods and results to facilitate the evaluation of a drug's therapeutic effectiveness. 

Outline of CSR:

The CSR comprises:

• A synopsis that provides a summary of the content in the CSR
• A methodology section, which introduces the study compound and the methods for conducting the study
• The results and conclusions sections, which present the data from the study and a summary of conclusions about the data. Generally, this consists of efficacy and safety results, though it might also include pharmacokinetic and/or pharmacodynamic results, as well as results from other exploratory variables
• Compilation of all the tables, figures, and lists (TFLs) from the results data, with links to data referenced in the CSR
• Appendices section of the CSR that any additional documentation related to the report and/or required by regulatory agencies

Who writes the CSR?

    The CSR requires the input, review, and approval of various study team members. However, the majority of the initial CSR draft text is written by a medical writer (MW), though there are variations in how different teams compile a CSR. For example, sometimes statisticians will write the efficacy results section of the CSR and the MW will write the synopsis, methodology, and safety sections.

How is the CSR written?

Once the statistical analysis plan (SAP) is final, the MW begins working on the “shell” or methodology section of the CSR. Using the protocol and SAP, the MW constructs an overview of the overall objectives of the study and what was planned to happen.

After the data (TFLs) from the study are final, the MW begins analyzing data to describe and present what actually happened during the study. Though MWs can choose to approach CSR writing from several angles, many choose to focus on the overall study population and safety sections first. This enables the writer to gain a firm grasp of safety issues that may have arisen, patients who were discontinued or withdrawn, and to understand the overall safety profile of the compound

A MW may then move on to the efficacy section and will often need to work with the statistician to clarify data related to the efficacy results. The last sections that a MW will compile are the discussion and conclusions sections. The discussion section should describe the study’s findings in the context of the current understanding of the therapeutic area and the compound’s known behavior. In the discussion section, support for each of the study’s final conclusions can be provided, though scientific literature should be referenced sparingly.

The MW develops a first draft, which will undergo an internal team review (consisting of various members of the study team) and QC before being sent to the client for review. Generally, a CSR will undergo 3 drafts before finalization. However, there are instances when it takes more than 3 drafts to produce a final report.

CSRs fulfill regulatory requirements, substantiate labeling information, support marketing authorization, inform the development of promotional messages for commercialization, and more.

When a clinical trial is submitted to regulatory agencies as part of an application for marketing approval of an intervention or new indication, the trial sponsors usually submit a detailed CSR.

Next: CDISC