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A Summary of Clinical Efficacy (SCE) is a section of the Clinical Summary placed in Module 2.7.3 of the Common Technical Document. The purpose is to provide a summary of the data relevant to the efficacy of a drug for the proposed indication in the intended population. In case of multiple indications, this section is to be duplicated, although closely related indications can be considered together.
The SCE includes a brief overview of the design of the studies that were conducted to evaluate the efficacy, a tabular listing of all studies that provided information relevant to product efficacy, as well as a comparison of efficacy results across studies. If available, all information on persistence of efficacy over time is also summarized.
The efficacy profile of the drug, described based on analysis of all clinical efficacy data, should be outlined in a detailed, clear, and objective manner, with use of tables and figures. The SCE will be developed based on the key messages, agreements on document content, and feedback from document review.
The Integrated Summary of Efficacy (ISE) is a critical component of the submission file in the US (placed in Module 5.3.5.3). Note that, despite the name, this is not a summary but rather an integrated analysis of all relevant efficacy data from clinical studies. The ISE text can be developed first and used to derive the SCE.
The role of the Medical writer is to ensure that the data are well structured, the key messages are brought forward clearly, it is a high-level summary (avoiding duplication), and to ensure consistency with other CTD documents that are developed in parallel.