ベネフィット・リスク評価におけるフレームワークの開発と動向

ベネフィット·リスクマネジメント/リスクコミュニケーション啓発委員会 海外情報分科会では、以下の論文・資料を参考にベネフィット・リスク評価のためのフレームワークについて検討しました。(2013年2月)

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ICH E2C

  1. 1.International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). E2C(R1) Guideline: Periodic Safety Update Report for Marketed Drugs. February 2003.
  2. 2.International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. Periodic Benefit-Risk Evaluation Report: E2C(R2). November 2012.
  3. 3.European Medicines Agency. New Pharmacovigilance legislation: Regulation (EU) No 1235/2010 Available from: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2010:348:0001:0016:EN:PDF. [Accessed February 15, 2013]
  4. 4.European Medicines Agency. New Pharmacovigilance legislation: Directive 2010/84/EU. Available from: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2010:348:0074:0099:EN:PDF. [Accessed February 15, 2013]
  5. 5.European Medicines Agency/Heads of Medicines Agency. Guideline on good pharmacovigilance practices: Module VII - Periodic safety update report (June 2012 EMA/816292/2011). Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2012/06/WC500129136.pdf. [Accessed February 15, 2013]
  6. 6.Council for International Organizations of Medical Sciences (CIOMS). Practical Aspects of Signal Detection in Pharmacovigilance: Report of CIOMS Working Group VIII. Geneva: CIOMS, 2010.
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  7. 7.International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. E2E Guideline: Pharmacovigilance Planning. November 2004..

EMA

  1. 1.European Medicines Agency. Report of the CHMP working group on benefit-risk assessment models and methods (London, 19 January 2007 Doc. Ref. EMEA/CHMP/15404/2007). Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2010/01/WC500069668.pdf. [Accessed February 15, 2013]
  2. 2.European Medicines Agency. Reflection paper on benefit-risk assessment methods in the context of the evaluation of marketing authorization applications of medicinal products for human use (London, 19 March 2008 Doc. Ref. EMEA/CHMP/15404/2007). Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2010/01/WC500069634.pdf. [Accessed February 15, 2013]
  3. 3.European Medicines Agency. Benefit-Risk Methodology Project (London, 12 March 2009 Doc. Ref. EMEA/108979/2009). Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Report/2011/07/WC500109477.pdf. [Accessed February 15, 2013]
  4. 4.European Medicines Agency. Benefit-risk methodology project Work package 1 report: description of the current practice of benefit-risk assessment for centralised procedure products in the EU regulatory network (London, 25 May 2011, EMA/227124/2011. Adopted in December 2009 - Revised for publication in March 2011). Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Report/2011/07/WC500109478.pdf. [Accessed February 15, 2013]
  5. 5.European Medicines Agency. Benefit-risk methodology project Work package 2 report: Applicability of current tools and processes for regulatory benefit-risk assessment (31 August 2010 EMA/549682/2010 - Revision 1, Human Medicines Development and Evaluation). Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Report/2010/10/WC500097750.pdf. [Accessed February 15, 2013]
  6. 6.European Medicines Agency. Benefit-risk methodology project Work package 3 report: Field tests (31 August 2011 EMA/718294/2011, Human Medicines Development and Evaluation). Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Report/2011/09/WC500112088.pdf. [Accessed February 15, 2013]
  7. 7.European Medicines Agency. Benefit-risk methodology project Work package 4 report: Benefit-risk tools and processes (9 May 2012 EMA/297405/2012 - Revision 1, Human Medicines Development and Evaluation). Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Report/2012/03/WC500123819.pdf. [Accessed February 15, 2013]
  8. 8.Guidance document on the content of the rapporteur day 80 critical assessment report Overview EMA/210563/2012. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2009/10/WC500004800.pdf. [Accessed February 15, 2013]
  9. 9.European Medicines Agency. Roadmap to 2015 The European Medicines Agency's contribution to science, medicines and health. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Report/2011/01/WC500101373.pdf. [Accessed February 15, 2013]

FDA

  1. 1.Institute of Medicine of the National Academies. Understanding the benefits and risks of pharmaceuticals Workshop Summary. 2007. Available from: http://www.nap.edu/catalog/11910.html [Accessed February 15, 2013]
  2. 2.Institute of Medicine of the National Academies. The Future of Drug Safety: Promoting and Protecting the Health of the Public. 2007. Available from: http://www.nap.edu/catalog/11750.html. [Accessed February 15, 2013]
  3. 3.Food and Drug Administration. Report to Congress Changing the Future of Drug Safety: FDA Initiatives to Strengthen and Transform the Drug Safety System, July 2009. [http://www.fda.gov/downloads/safety/safetyofspecificproducts/ucm184046.pdf]
  4. 4.Food and Drug Administration. Report to Congress Changing the Future of Drug Safety: FDA Initiatives to Strengthen and Transform the Drug Safety System, July 2009. Available from: http://www.fda.gov/downloads/safety/safetyofspecificproducts/ucm184046.pdf. [Accessed February 15, 2013]
  5. 5.The NewYork Academy of Sciences. Risk-Benefit Considerations in Drug Regulatory Decision-Making, Apr 2010. Available from: http://www.nyas.org/events/Detail.aspx?cid=ba88a2a4-9dd3-4150-b8c6-021cfc899310. [Accessed February 15, 2013]
  6. 6.Jenkins J. A United States Regulator's Perspective on Risk-Benefit Considerations (April 23, 201022). Available from: http://www.fda.gov/downloads/AboutFDA/CentersOffices/CDER/UCM210155.pdf. [Accessed February 15, 2013]
  7. 7.Patric Frey, Benefit-Risk Considerations in CDER: Development of a Qualitative Framework (June 28, 2012). Available from: http://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/UCM317788.pdf. [Accessed February 15, 2013]
  8. 8.Institute of Medicine of the National Academies. Ethical and Scientific Issues in Studying the Safety of Approved Drugs. Available from: http://www.nap.edu/catalog/13219.html. [Accessed February 15, 2013]
  9. 9.US FDA PDUFA V Reauthorization Performance Goals and Procedures Fiscal Years 2013 through 2017. Available from: http://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM270412.pdf. [Accessed February 15, 2013]
  10. 10.Hobbs NM. FDA's Benefit/Risk Framework Will Focus On Communication, Not Quantification. Health News Daily June 21 2012.

BRAT

  1. 1.Coplan PM, Noel RA, Levitan BS, et al. Development of a Framework for Enhancing the Transparency, Reproducibility and Communication of the Benefit-Risk Balance of Medicines. Clinical pharmacology & Therapeutics 2011; 89(2):312-5.
  2. 2.Levitan BS, Andrews EB, Gilsenan A, et al. Application of the BRAT Framework to Case Studies: Observations and Insights. Clinical pharmacology & Therapeutics 2011; 98(2): 217-24.
  3. 3.Council for International Organization of Medical Science. Benefit-Risk Balance for Marketed Drugs: Report of CIOMS Working Group IV. Geneva: CIOMS, 1998.

CIRS

  1. 1.Mussen F, et al. A quantitative approach to benefit-risk assessment of medicines -part 1: The development of a new model using multi-criteria decision analysis; Pharmacoepidemiology and Drug Safety 2007; 16: S2-S15.
  2. 2.Mussen F, Salek S and Walker SR, eds. Benefit-Risk Appraisal of Medicines: A Systematic Approach to Decision Making. John Wiley: Surrey, UK. 2009.
  3. 3.Walker S, Liberti L, McAuslane N. Refining the benefit-risk framework for the assessment of medicines: Valuing and weighting benefit and risk parameters. Clin Pharmacol Ther 2011;89(2):179-182.
  4. 4.Walder S, McAuslane N, Liberti L, Connelly P. Building the benefit-risk toolbox: Are there enough common elements across the different methodologies to enable a consensus on a scientifically acceptable framework for making benefit-risk decisions? Centre for Innovation in Regulatory Science: August 2012. Available from: http://cirsci.org/system/files/private/CIRS_June_2012_Workshop_Synopsis.pdf. [Accessed February 15, 2013]

フレームワークの開発と動向

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