Benefit–risk assessment in medicine has been a valuable tool in the regulation of medicines since the 1960s. Benefit–risk assessment takes place in multiple stages during a medicine’s life-cycle and can be conducted in a variety of ways, using methods ranging from qualitative to quantitative. Each benefit–risk assessment method is subject to its own specific strengths and limitations. Despite its widespread and long-time use, benefit–risk assessment in medicine is subject to debate and suffers from a number of limitations and is currently still under development.this state of the art review paper will discuss the various aspects and approaches to benefit–risk assessment in medicine in a chronological pathway. The review will discuss all types of benefit–risk assessment a medicinal product will undergo during its lifecycle, from phase i clinical trials to post-marketing surveillance and health technology assessment for inclusion in public formularies. The benefit–risk profile of a drug is dynamic and differs for different indications and patient groups. In the end of this review we conclude benefit–risk analysis in medicine is a developed practice that is subject to continuous improvement and modernisation. Improvement not only in methodology, but also in cooperation between organizations can improve benefit–risk assessment.
Luteijn, J., White, B., Gunnlaugsdottir, H., Holm, F., Kalogeras, N., Leino, O., Magnusson, S., Odekerken-Schröder, G. J.
, Pohjola, M., Tijhuis, M. J., Tuomisto, J., Ueland, O., McCarron, P. A., & Verhagen, H. (2012). State of the art in benefit-risk analysis: medicines
. Food and Chemical Toxicology
(1), 26-32. https://doi.org/10.1016/j.fct.2011.06.008