title: Statistical aspects in comparative benefit-risk assessment: challenges and opportunities for pharmaceutical statisticians.
abstract: Benefit-risk assessment is a fundamental element of drug development with the aim to strengthen decision making for the benefit of public health. Appropriate benefit-risk assessment can provide useful information for proactive intervention in health care settings, which could save lives, reduce litigation, improve patient safety and health care outcomes, and furthermore, lower overall health care costs. Recent development in this area presents challenges and opportunities to statisticians in the pharmaceutical industry. We review the development and examine statistical issues in comparative benefit-risk assessment. We argue that a structured benefit-risk assessment should be a multi-disciplinary effort involving experts in clinical science, safety assessment, decision science, health economics, epidemiology and statistics. Well planned and conducted analyses with clear consideration on benefit and risk are critical for appropriate benefit-risk assessment. Pharmaceutical statisticians should extend their knowledge to relevant areas such as pharmaco-epidemiology, decision analysis, modeling, and simulation to play an increasingly important role in comparative benefit-risk assessment.
authors: Statistics Methods and Research Group, F. Hoffmann-La Roche, Welwyn Garden City, UK. george.quartey@roche.com
authors: George
authors: G
authors: Quartey
authors: Jixian
authors: J
authors: Wang
mesh_terms: D003198:Computer Simulation; D003362:Cost-Benefit Analysis / Q000379:methods; D003657:Decision Making; D015195:Drug Design; D004345:Drug Industry / Q000379:methods; D064420:Drug-Related Side Effects and Adverse Reactions; D017048:Health Care Costs; D006801:Humans; D015233:Models, Statistical; D004364:Pharmaceutical Preparations / Q000008:administration & dosage / Q000191:economics; D017891:Pharmacoepidemiology / Q000379:methods; D018570:Risk Assessment
chemical_list: D004364:Pharmaceutical Preparations