The CO should describe the strengths and weaknesses of the development programme, present the study results/published data, analyse the benefits and risks of the medicinal product in the proposed indication(s) and describe how the study results/published data support critical parts of the prescribing information.
The Clinical Overview (CO) is a vital part of the Common Technical Document (CTD), especially in the EU. When well written, it is an invaluable resource that medical assessors in regulatory authorities use to orientate themselves to understand the scope of, the Applicant’s rationale for and critical issues in the clinical development programme. However, more often than not, a CO is not well written. It is not easy to write a truly critical, yet appropriately supportive, assessment of the data that has to justify the proposed Summary of Product Characteristics (SmPC).