Clinical Study Reports (CSRs) are subject to increasing regulatory attention, highlighting the importance of creating a compelling, well-structured document.
Presenting the data and results from your study in the best possible way maximizes your opportunity to receive approval. Medical writers specialize in developing these essential reports and can offer unique insights into how you can set your CSR up for success while the study is still underway.
CSRs are not written for lay audiences—however, the medical writer must ensure the document is clear and concise, allowing the study results to be easily understood and interpreted. Additionally, the regulatory submission dossier of any drug includes CSRs from each study conducted during all phases of clinical development, emphasizing the importance of consistency throughout the entire submission package.
Elements of an impactful Clinical Study Report
The foundational elements of a successful CSR are clear writing and keen attention to detail (e.g., accuracy, consistency, style, formatting, and more). This approach ensures the best use of the reviewers’ time and facilitates an efficient review of the document.
Beyond aesthetics, the medical writer will also be responsible for presenting your study’s data transparently and without bias. The data should be described based on the study design of the protocol and the pre-defined statistical analysis plan (SAP). In addition, the medical writer works with the sponsor to ensure that the results text represents the findings of the study. Working collaboratively with the sponsor, the medical writer can elevate the outcome of your statistical story and give you the best opportunity to gain approval.
Informing study design best practices
Of all the study components that can affect the development of the CSR, few are as impactful as the study design. After all, the content of the CSR can only reflect what was planned in the study protocol and the SAP-defined analyses. Having a well-thought-out and well-written protocol is vital to ensuring the CSR summarizes the appropriate data to establish the study drug’s safety and effectiveness.
While the protocol and the SAP can be amended, it is preferable to develop these documents with SME input and guidance, including the medical writer and biostatistician, to ensure that the applicable endpoints are defined from the onset of the study. This can help sponsors avoid the challenges of trying to capture additional endpoints later, which may result in missing important data points from earlier study participants.
Adjusting timelines to account for quality control
By developing timelines for CSR development with the medical writer, we can plan for drafts of the document to be reviewed by both the sponsor team and your partner CRO. Timelines may include a complete quality control (QC) check by a medical writer to confirm content is consistent with the protocol study design and SAP-defined analyses, a full check of in-text data against the source data outputs, as well as stylistic considerations, including formatting and overall consistency.
As your team’s time is valuable and limited, regular medical writer involvement helps to ensure each draft of your report is manicured and ready for send-out to reviewers according to the established timeline.
With early involvement, medical writers can work alongside sponsor teams to ensure that the content of the CSR reflects the study design as described in the protocol and the results are summarized to reflect the endpoints described in the SAP. This collaboration can help to ensure on-time submissions, maximize the impact of your data’s story, and streamline the review of program-level documents to regulators to see a clear and consistent message across all stages of development.
Meredith Latino is the Director of Medical Writing at Precision for Medicine. She earned a PhD in Molecular and Cellular Biology from Tulane University and brings more than 16 years of experience to the Precision team, including 9 years of medical writing and 8 years of academic research/writing.
Precision for Medicine is part of the Precision Medicine Group, an integrated team of experts that extends Precision for Medicine’s therapeutic development capabilities beyond approval and into launch strategies, marketing communication, and payer insights. As one company, the Precision Medicine Group helps pharmaceutical and life-sciences clients conquer product development and commercialization challenges in a rapidly evolving environment.