A clinical study report (CSR) describes the conduct and results of an individual clinical trial. The CSR is a component of regulatory submissions (i.e., the Common Technical Document) and is essential for ultimate approval.
Lean CSR writing is ‘focused writing,’ followed widely across the clinical research industry. Most CSRs are data-driven and will be authored in once the statistical analysis is completed.
Previously, CSR writing was approached as storytelling, resulting in lengthy documents with duplicate information. However, using a lean approach instead, which focuses on writing only the key messages, significantly reduces the length of CSR and decreases the time required to author and review the CSR. The lean writing approach also reduces data errors and improves the overall quality of the document.
This blog outlines three best practices to use when writing lean CSRs.
Information is to be stated only once in the document. Avoid redundant information.
For example, in a CSR shell, you can refer to the protocol and statistical analysis plan for the available information. You can also use Smart Templates with technical functions that enable automation and clinical content reuse to make things even easier.
Do not repeat data values presented in the source tables for CSR results. Doing so will avoid data errors and minimize the time required for quality checks. Instead, you can add the key interpretations (see next tip) and include a cross-reference to the source tables.
You should not populate in-text tables if the content and presentation are the same as the source tables; just a cross-reference to the source table is sufficient.
Refer to other sections, tables, and appendices as much as possible instead of repeating the data.
Interpret Key Results
Focus on key information and statistical results per study objectives and endpoints. A few examples are as follows:
- Interpretation based on statistical tests, present p-values.
- For presenting a change from baseline results, do not show the baseline and changed values. Instead, only show if an increase or decrease is observed per the values from baseline results
- Present a trend within treatment groups. Compare the active versus placebo groups and data from different doses or treatments.
- For safety results, common adverse events (AE), serious AEs, and AEs of special interest with cut-off % values can be presented, like ≥ 5%. The cut-off is decided based on sample size and the number of subjects experiencing AEs.
- State if any changes in the laboratory or vital sign parameters were significant and if any AEs were reported.
Organize the Information
How information is presented significantly affects the reading experience and interpretation.
A few tips below:
- Follow the ‘F’ pattern. Use bulleted short sentences instead of lengthy sentences.
- Tailor or shorten source tables as in-text tables to provide the required key information.
- State the key message first, followed by the supporting messages and reference source data.
- Present information in a consistent order.
- Use consistent terminology.
Ask yourself these three questions while writing to ensure the end result is an effective lean CSR:
- Is the text really needed? Be concise!
- Is the message and result clear and accurate?
- Is the information well presented?
Author: Dipti Palkar, Senior Principal Medical Writer, Regulatory Medical Writing