The Clinical Overview is an integral component of Module 2.5 of the Common Technical Document (CTD) for prospective
clinical studies conducted by the product innovator. The Clinical Overview succinctly presents crucial and extensive data from drug development presented in other CTD modules and facilitates the critical review of a drug's benefit-risk profile. This summarized document is, therefore, a pivotal part of drug approval
submission to regulatory agencies like the FDA or EMA. It enables the health authorities (HAs) to make an informed decision on the approval of a product for marketing through a document that summarizes the extensive detail provided in other sections of the CTD.
What is a Common Technical Document (CTD)? CTD serves as a standardized submission format for the regulatory approval of pharmaceutical and biologic products. This structured document is represented by the CTD triangle, illustrating its organization into three main modules: Quality (Module 3), Safety (Module 4), and Efficacy (Module 5). These modules systematically present information on product quality, safety, and efficacy. Additionally, two supporting modules, Administrative and Prescribing Information (Module 1) and Nonclinical Overview (Module 2), contribute to the comprehensive data submitted to regulatory authorities. The CTD triangle provides a systematic framework for presenting data, facilitating the evaluation of a product's safety, efficacy, and quality throughout its development and registration process.
Authoring Clinical Overviews presents several challenges due to the complexity of the drug development process, the vast data available for analysis and presentation, and the stringent regulatory requirements, including but not limited to: