Benefit-risk evaluation: the past, present and future

被引：26
作者：
Juhaeri, Juhaeri [1 ]
机构：
[1] Sanofi, 55 Corp Dr, Bridgewater, NJ 08807 USA
来源：
THERAPEUTIC ADVANCES IN DRUG SAFETY | 2019年 / 10卷
关键词：
benefit-risk; methods; patient; preference; quantitative; structured; weight; DECISION-ANALYSIS; PATIENTS PREFERENCES; PATIENT; PHYSICIAN;
D O I：
10.1177/2042098619871180
中图分类号：
R9 [药学];
学科分类号：
1007 ;
摘要：
In the last two decades there has been a shift in the approach to evaluating the benefit-risk (BR) profiles of medicinal products from an unstructured, subjective, and inconsistent, to a more structured and objective, process. This article describes that shift from a historical perspective; the past, the present, and the future, and highlights key events that played critical roles in changing the field.
引用
收藏
页数：10
相关论文
共 43 条
  • [11] European Medicines Agency, 2012, BEN RISK METH PROJ W
  • [12] Users' guides to the medical literature - XVI. How to use a treatment recommendation
    Guyatt, GH
    Sinclair, J
    Cook, DJ
    Glasziou, P
    [J]. JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, 1999, 281 (19): : 1836 - 1843
  • [13] Benefit-risk assessment in a post-market setting: a case study integrating real-life experience into benefit-risk methodology
    Hallgreen, Christine E.
    van den Ham, Hendrika A.
    Mt-Isa, Shahrul
    Ashworth, Simon
    Hermann, Richard
    Hobbiger, Steve
    Luciani, Davide
    Micaleff, Alain
    Thomson, Andrew
    Wang, Nan
    van Staa, Tjeerd P.
    Downey, Gerald
    Hirsch, Ian
    Hockley, Kimberley
    Juhaeri, Juhaeri
    Metcalf, Marilyn
    Mwangi, Jeremiah
    Nixon, Richard
    Peters, Ruth
    Stoeckert, Isabelle
    Waddingham, Ed
    Tzoulaki, Ioanna
    Ashby, Deborah
    Wise, Lesley
    [J]. PHARMACOEPIDEMIOLOGY AND DRUG SAFETY, 2014, 23 (09) : 974 - 983
  • [14] Hammond JS., 1999, SMART CHOICES PRACTI, P4
  • [15] Incorporating patient-preference evidence into regulatory decision making
    Ho, Martin P.
    Gonzalez, Juan Marcos
    Lerner, Herbert P.
    Neuland, Carolyn Y.
    Whang, Joyce M.
    McMurry-Heath, Michelle
    Hauber, A. Brett
    Irony, Telba
    [J]. SURGICAL ENDOSCOPY AND OTHER INTERVENTIONAL TECHNIQUES, 2015, 29 (10): : 2984 - 2993
  • [16] Benefit-risk analysis: examples using quantitative methods
    Holden, WL
    Juhaeri, J
    Dai, WJ
    [J]. PHARMACOEPIDEMIOLOGY AND DRUG SAFETY, 2003, 12 (08) : 693 - 697
  • [17] Benefit-risk analysis: a proposal using quantitative methods
    Holden, WL
    Juhaeri, J
    Dai, WJ
    [J]. PHARMACOEPIDEMIOLOGY AND DRUG SAFETY, 2003, 12 (07) : 611 - 616
  • [18] Patient-Focused Drug Development Methods for Benefit-Risk Assessments: A Case Study Using a Discrete Choice Experiment for Antiepileptic Drugs
    Holmes, Emily A. F.
    Plumpton, Catrin
    Baker, Gus A.
    Jacoby, Ann
    Ring, Adele
    Williamson, Paula
    Marson, Anthony
    Hughes, Dyfrig A.
    [J]. CLINICAL PHARMACOLOGY & THERAPEUTICS, 2019, 105 (03) : 672 - 683
  • [19] Recommendations for benefit-risk assessment methodologies and visual representations
    Hughes, Diana
    Waddingham, Ed
    Mt-Isa, Shahrul
    Goginsky, Alesia
    Chan, Edmond
    Downey, Gerald F.
    Hallgreen, Christine E.
    Hockley, Kimberley S.
    Juhaeri, Juhaeri
    Lieftucht, Alfons
    Metcalf, Marilyn A.
    Noel, Rebecca A.
    Phillips, Lawrence D.
    Ashby, Deborah
    Micaleff, Alain
    [J]. PHARMACOEPIDEMIOLOGY AND DRUG SAFETY, 2016, 25 (03) : 251 - 262
  • [20] Hunink MGM, 2014, DECISION MAKING IN HEALTH AND MEDICINE: INTEGRATING EVIDENCE AND VALUES, 2ND EDITION, P1, DOI 10.1017/CBO9781139506779
12345