Measures for Conducting Comparative Benefit: Risk Assessment
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Christy Chrarg-Stein Statistical Research and Consulting Center. Pfizer Inc. Richard Entsrah Merck Research Labs Yili Pritchett Global Statistics. Abbott Laboratories Key Words Benefikrisk ratio; Benefit-lessrisk measure; Benefit:risk index; Global benefit :risk score; Number needed to treat; T w i n ; Q-TwiSr Correspondence Address Christy Chuang-Stein. 5857 Stoney Brook Rd.. Kalamazoo, MI 49009 (email: [email protected]). The Drug Information Association is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians. The Drug Information Association designates this educational activity for a maximum of 1 AMA PRA Category 1 Credit(s)m. Physicians should only claim credit commensurate with the extent oftheirparticipafion in the activity. The Drug Information Association is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. This progmm is designatedfor a maximum of 1 contact hour or. 1 continuing education units (CEUS).286-000-04-019-H04.
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Measures for Conducting Comparative Benefit:Risk Assessment think diligently on the trade-off between benefit and risk in a structured manner. Even though we discuss measures to facilitate benefittrisk assessment in this article, we want to remind the readers that it cannot replace the rigorolcs assessment of efficacy and safety individualb Raths it complements the tmditionally separate safety and eficacy analysis by bringing safety and eficacy assessment together in a unified appnmch.
In this article, we review quantitative measures that have been proposed to conduct comparative benefittrisk assessment. Comparative ben4t:risk assessment could be conducted at the societal level (recommending drug approval or the adoption of a medical pdicy) or at the individual level (making a treatment selection). Benefittrisk assessment invaives balancing between benefit and risk. The need to make decisions based on all information forces us to LeamingObjectives
Upon completion of this article, participants should be able to: Identifl and evaluate quantitative meancres that have been pmposed to conduct compamtive benefittriskassessment.
Target Audience n i s article is designedfor aA involved in the desigdanalysisof clinical trials as well as those involved in the evaluations of phannaceuticalproduds.
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