Net efficacy adjusted for risk: further developments

Abstract

NEAR results may be optimised by considering the type of population analysed, ITT or PP. Meta-analyses using NEAR as effect size provide new insights into CT results. Last, correcting certain deficits in adverse drug reactions reporting is required in CT risk assessment.

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

“…Literature searches identified approximately 7000 potentially relevant articles. Following title and abstract screening, we scrutinized the full text of 129 and agreed that 40 were eligible for further examination . Seven other articles on benefit–risk methodologies were identified from other sources including journals, books and internal reports .…”

“…Trade-off indices integrate benefits and risks into a single metric representing the value of the trade-off for direct interpretation of whether a treatment option is favourable or unfavourable. Multicriteria decision analysis BLRA 61 Benefit-less-risk analysis MCE 62,63 Minimum clinical efficacy Beckmann 49,64 Beckmann model (aka evidence based-model) MDP 50,65 Markov decision process BRAFO 39 Benefit-risk analysis for foods MTC 3,4,66 Mixed treatment comparison BRAT 53,67 Benefit-risk action team NCB 68 Net clinical benefit BRR 16,69,70 Benefit-risk ratio NEAR 12,71 Net efficacy adjusted for risk CA 72,73 Conjoint analysis NNH 62,74 Number needed to harm CDS 2,75,76 Cross-design synthesis NNT 62,74 Number needed to treat CMR CASS 77 Confidence profile method PrOACT-URL 82,83 Problem, objectives, alternatives, consequences, trade-offs, uncertainty risk, and linked decisions framework CUI 27,84,85 Clinical utility index PSM 86,87 Probabilistic simulation method CV [88][89][90] Contingent valuation QALY 30,31 Quality-adjusted life years DAG [91]…”