What is Patient-Centricity

A core element in protecting human participants in clinical research is the assurance of a favorable risk-benefit balance, in accordance with the ethical principle of beneficence. However, the assessment of risks and benefits may sometimes be challenging. In this chapter, the authors review the concepts, ethical principles, and applicability of those terms. The assessment approaches used by regulators and research reviewers who are working in clinical practice are then discussed, together with a highlight of the new trends in risk-benefit analysis and their impact on drug development and approval. Analysis of some research situations which pose particular challenges are presented at the end of the chapter.