What is a Clinical Study Report?
A Clinical Study Report (CSR) is a document that describes the methods and results of a clinical study or trial, along with a short discussion of key findings related to the study. There are guidelines for CSRs which are defined in The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) E3 guidance and which dictate the overall structure of the CSR and the presentation of content within it.
What is the Outline of a 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
- Section 14, which is a compilation of all the tables, figures, and lists (TFLs) from the results data, with links to data referenced in the CSR
- Section 16, which is the appendices section of the CSR and includes 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 This enables the writer to gain a firm grasp of safety issues that may have arisen, patients who were discontinued or withdrawn, and to understand the overall safety profile of the compound.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.
What is the most important part of writing a CSR?
While it is difficult to pin-point one overall area of focus, the primary endpoints will dictate the pivotal results that will need to be described in the report. Before getting there, however, it is important to have a clear understanding of how the data will be laid out and what the key messages are. It is essential to work with the overall study team to accomplish this.
What is the most difficult part of putting a CSR together?
Writing a CSR is a long and detailed process. There are multiple timelines and milestone markers associated with writing the CSR and it can be difficult to balance these, as they often shift due to factors outside the MW’s control. As far as the report is concerned, the discussion section often poses the most difficulty for a writer as there is not enough time for a MW to acclimate to the research environment of each compound they write about, so the knowledge of the project team is essential for getting this section right.
ProPharma Group is committed to producing high-quality, scientifically-driven CSRs. Our highly experienced MWs have worked in numerous therapeutic areas for a multitude of clients. Our attention-to-detail, rigorous adherence to timelines, quality‑centric-focus, and exceptional client and team communication ensure that the CSR we provide is developed, executed, and delivered to exceed expectations.
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