How to Write CSR Conclusions
Many clinical development teams struggle with how to write crisp, well-messaged efficacy and safety conclusions within a CSR. Below are a few simple tips for writers and reviewers to keep in mind:
Start with the Objectives. If you are struggling with where to start, answer the simple questions posed by your study objectives. Effective conclusions synthesize the results of their respective sections (efficacy, safety, PK, or PD) and allow the reader, the third-party regulator, to understand if the trial met its objectives.
Stick to the Facts. CSR conclusions should be based on the evidence (study data). Include the key data which support the key messages. While it is appropriate to interject relevant study-specific context to aid in data interpretation, avoid unfounded adjectives and hyperbole.
Streamline. Get buy-in from the study team SMEs and restrict the content to highlight what is most important. Avoid a reiterative data dump of every analysis from the respective sections so that key data are not buried or lost.
Stay within the Study. Conclusions are not the place for cross-trial comparisons or contextualization of the results relative to other therapies; reserve that type of analysis for the discussion.
Justin McLaughlin
Acumen CEO