Spring Intro 2023

06/03/2023

Clinical trial design is not driven by biotechnology status

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Clinical

• General principles for establishing efficacy and safety same as for New Chemical Entities (NCEs) ● Case by case based on therapeutic indication and patient population • Phases of development can be blurred due to patient populations targeted e.g. oncology ● Guideline on the evaluation of anticancer medicinal products in man (EMA/CHMP/205/95/Rev4) • Tegenero incident (2006) highlighted importance of understanding immunological controls/cascade mechanisms before implementing clinical trials ● Guidelines on strategies to identify and mitigate risks for first-in-man clinical trials with investigational medicinal products (EMEA/CHMP/SWP/294648/2007)

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