Alain Micaleff

Balancing benefit and risk of medicines: a systematic review and classification of available methodologies.

The need for formal and structured approaches for benefit–risk assessment of medicines is increasing, as is the complexity of the scientific questions addressed before making decisions on the benefit–risk balance of medicines. We systematically collected, appraised and classified available benefit–risk methodologies to facilitate and inform their future use.

Recommendations for benefit–risk assessment methodologies and visual representations

The purpose of this study is to draw on the practical experience from the PROTECT BR case studies and make recommendations regarding the application of a number of methodologies and visual representations for benefit–risk assessment.

Benefit-risk assessment in a post-market setting: a case study integrating real-life experience into benefit-risk methodology.

Difficulties may be encountered when undertaking a benefit–risk assessment for an older product with well‐established use but with a benefit–risk balance that may have changed over time. This case study investigates this specific situation by applying a formal benefit–risk framework to assess the benefit–risk balance of warfarin for primary prevention of patients with atrial fibrillation.

Weighing benefit–risk of medicines: concepts and approaches

Formal methods for decision-making based on benefit–risk analysis have existed for many years in various settings, but have only recently being explored in Medicine for use by various stakeholders including patients, physicians, regulators and pharmaceutical industry. We review the rationale for using these formal approaches; describe the basic concepts required; outline some competing approaches that have been proposed, illustrating them with examples, refer more briefly to other approaches and describe current initiatives in this domain.

Literature review of visual representation of the results of benefit–risk assessments of medicinal products

The PROTECT Benefit–Risk group is dedicated to research in methods for continuous benefit–risk monitoring of medicines, including the presentation of the results, with a particular emphasis on graphical methods.