The Council for International Organizations of Medical Sciences (CIOMS) has released a new report offering valuable insights into the methodologies used to assess the benefit-risk (BR) balance of medicinal products.
Establishing a favourable BR profile is essential before any medicinal product reaches the market. However, this balance must be continuously re-evaluated throughout the product’s lifecycle, especially as new data emerges on its use, safety, and effectiveness in real-world settings.
Notably, specific considerations have been outlined for special populations such as those with rare diseases, paediatric patients, and the elderly, as data are often lacking for these groups, which can impact BR balance assessments.
This comprehensive report is aimed at a wide audience, from pharmaceutical developers and regulatory authorities to academic and government researchers, healthcare professionals, and even patients and consumers, or anyone with an interest in how the benefits and risks of medicines are weighed and managed.
Find out more on the CIOMS website.