The Clinical Summary is a summary of clinical information provided in ICH E3 clinical study reports or obtained from any meta-analyses or other cross-study analyses for which full reports have been included in Module 5, as well as post-marketing data for products that have been marketed in other regions. The purpose of the Clinical Summary is to provide a detailed, factual summarization of the clinical information in the Common Technical Document (Module 2.7).
It is divided into sections (hereafter referred to as ‘summaries’) covering biopharmaceutics and associated analytical methods, clinical pharmacology, efficacy, and safety. In the Summary of Clinical Safety, the emphasis is on the integrated data across studies, while in the other summaries, the emphasis is on the individual study results. In all summaries, the comparisons and analyses of results across studies should focus on factual observations.
The Clinical Summary can be quite challenging, especially when it concerns a large and complex dossier. This document should present only the key information extracted from a large set of data; require input from a wide range of stakeholders (who are also involved in several other CTD components); and are (often) written concurrently by different authors. Including only essential information might be challenge due to the tendency to be ‘thorough’, although all data are provided in the more detailed sections of the dossier (to which a cross-reference can be made).
The establishment of a document strategy is very important. Getting agreement on the key messages, the document content, and the timelines is needed before moving forward.
One Medical Writer can take the lead role for the oversight of the document development process (eg, planning activities for all summaries, consistency between documents). The individual summaries require one or more dedicated Medical Writers who can focus on their development, such as writing and implementing of comments from various team and management review cycles, and who need to communicate with the other writers as frequently as needed to ensure consistency across documents.