Clinical study reports

Writing a Clinical Study Report

What is a clinical study report (CSR)?

A CSR is a technical document describing the conduct and outcomes of a clinical trial. It can help facilitate future research and medical treatment, is important for drug and device development and approval, and:

Outlines trial aims, objectives, and endpoints.
Details how the clinical trial was designed.
Describes how data were analysed and which statistical tests were performed.
Presents the trial findings in tabular form and summarises these data.
Specifies any safety issues.
Discusses the trial findings.
Provides a synopsis on the key trial findings.
Standard appendices provide key information on the conduct of the trial.

Why do you need a CSR?

Foremostly, CSRs are required by regulatory authorities, as part of the common technical document (CTD) used for marketing applications in Europe, the United States, Japan, and beyond. Article 37 of the EU Clinical Trial Regulation requires a clinical summary to be provided to the regulatory authority within a year of the clinical trial finishing irrespective of the trial outcomes. CSRs associated with marketing authorisation approved via the European Medicines Agency centralised procedure are added to a publicly accessible database. Sensitive information protecting the trial sponsor’s business interests may remain undisclosed. Sometimes CSRs are used for systematic reviews and meta-analyses that combine data from multiple trials.

Not all CSRs are the same; regulatory authorities may permit an abbreviated CSR, such as when reporting a clinical trial that was not designed to support treatment effectiveness. Interim CSRs are used when reporting the progression of an ongoing clinical trial. Synoptic CSRs are prepared for trials that provide safety data, but do not report the effectiveness and clinical pharmacology of the medicinal product. A full CSR, nevertheless, is the most comprehensive and standard type of report.

The CSR is a key concept of good clinical practice as outlined in regulatory International Council for Harmonisation (ICH) guidelines [E6(R2)]. Its content is prescribed by ICH E3, and standard templates and authoring guidelines are offered by the cross-regional organisations CORE (Clarity and Openness in Reporting) Reference and TransCelerate.

How do you write a CSR?

When writing a CSR, attention to detail and accuracy is critical! A well-written and well-structured CSR will support a pharmaceutical company’s drug development programme, so always consider the document’s purpose. CSRs need to provide a detailed account of the trial outcomes with respect to the objectives stated in the protocol in a clear and logical format and be digestible for all readers.

Language needs to be concise, accurate, and of simple sentence construction. Writing in the active voice can help to simplify sentences. Use correct technical scientific terminology but avoid jargon that may distract the reader. In-text tables and figures should be clear, easy to understand, and underline the key results and conclusions of the trial. Abbreviations need to be correctly defined, and the effective use of crosslinks allow the reader to easily navigate the document and helps prevent repeating text in other sections. References must be appropriately cited, grammar correctly used, and the data well presented. Importantly, all personally identifiable information must be anonymised.

At Alchemy, we break the process down into manageable pieces. Earlier background sections of the CSR are completed using source documents such as the study protocol, statistical analysis plan, and any related publications. We call this ‘creating a shell’, and it can be performed in advance of the trial data being finalised. These earlier sections introduce the trial rationale, cover ethical approval, detail the trial design, outline the objectives and endpoints, and list the inclusion and exclusion criteria. Creating a shell can also include mapping out the results sections in terms of the pre-defined endpoints. Completing the CSR shell early on can help with identifying missing material and troubleshooting any potential problems.

Results sections are fully populated once the data are finalised. Adopt a systematic approach to your writing when describing each data set and keep this writing style consistent throughout these sections of the document.

It is standard to first introduce the source documents, then present the data, which should be summarised in tables. It is important to explain the data simply and without interpretation, drawing attention to statistically significant findings, meaningful changes in parameter measurements, and any notable data trends. Finally, use crosslinks to direct the reader to the in-text tables in which the data are presented.

The medical writer collaborates with the client to accurately summarise the key trial findings in the discussion section. Conclusions relating to the trial objectives and endpoints are presented as bullet points.

The synopsis summarises the whole report and is the final section of the CSR to be completed. Additional information not reported within the main body of the report can be included within the appendices.

How can Alchemy help with your CSRs?

Outsourcing the writing of CSRs to medical writing agencies like Alchemy saves your team time and resources. Writing a CSR is a team effort involving multiple stakeholders from different disciplines (e.g., clinicians, safety experts, biostatisticians, clinical trial management team), and multiple rounds of review, followed by comment resolution, and quality control. At Alchemy, we are highly experienced in managing the process from start to finish, liaising with all stakeholders and delivering to timelines.

Our operating procedures and quality check services guarantee excellence. Because we are experts in medical writing across the board, we can see beyond CSRs to related deliverables, including lay language summaries, redacted versions of CSRs, publications such as manuscripts in peer review journals, posters, and presentations. We can author other regulatory documents to support your clinical studies (e.g., protocols, Investigator’s Brochures, patient narratives, etc.), and summary documents that form Module 2.7 of the Common Technical Document.

Importantly, we offer a friendly, bespoke service that you can rely on, and we are passionate about what we do.