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临床试验中应用PRO评价的伦理学思考 被引量：9

The Ethical Consideration on Evaluating PRO in Clinical Biomedical Researches
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摘要 在介绍患者报告结局(PRO)概念与内涵的基础上,阐述了PRO的伦理学原则,进而提出了PRO量表在实际应用中的一些难题。建议临床试验在规范化、科学化、法制化建设的同时,更要认真对待并及时解决临床试验中所面临的各种伦理问题,广泛应用和推广PRO评价,切实保障临床试验受试者的安全与权益。 Based on the introduction of the concept and connotation of patient reported outcomes （PRO） this paper puts forward principles of ethics and some problems in the practical application of PRO scale. Suggest that ethical issues should be taken seriously and solve with the standardized, scientific and legalization construction in clinical trials. PRO evaluation should be widely applied and extended to ensure the safety and equity of clinical trial subjects.
作者 张岩波 王洪奇 白文瑾
机构地区 山西医科大学公共卫生学院 山西医科大学人文社会科学学院
出处 《医学与哲学（A）》 北大核心 2011年第1期20-21,共2页 Medicine & Philosophy:Humanistic & Social Medicine Edition
基金 山西省科技基础条件平台建设项目"临床PRO评价系统与分析技术平台建设" 项目编号:2010091018
关键词 患者报告结局 医学伦理学 临床评价 patient- reported outcomes （ PRO）, medical ethics, clinical evaluation
分类号 R-052 [医药卫生]
  • 相关文献

参考文献6

  • 1陈薇,刘建平.临床疗效研究中的患者报告结局[J].中国中西医结合杂志,2009,29(8):746-749. 被引量：26
  • 2FDA. Guidance for industry patient--reported outcome measures: use in medical product development to support labeling claims, draft guidance[J]. Health Oual Life Outcomes,2006,4: 79.
  • 3Patient Reported Outcomes Harmonization Group. Harmonizing patient reported outcomes issues used in drug development and evaluation[R/ OL]. [2010- 05 01]. http;//www, eriqa-project, com/pro-harmo/ home. html.
  • 4刘凤斌,方积乾,王建华.中医药临床疗效评价的探讨[J].中药新药与临床药理,2004,15(4):290-292. 被引量：92
  • 5国家食品药品监督管理局.药品临床试验管理规范[R].北京:国家食品药品监督管理局,2003.
  • 6张艳宏,刘保延,何丽云,訾明杰.病人报告的临床结局研究与实际应用[J].中西医结合学报,2008,6(11):1101-1104. 被引量：23

二级参考文献32

  • 1林丽珠.人参注射液在中晚期恶性肿瘤化疗中的协同作用——附66例临床分析[J].新中医,1997,29(2):19-21. 被引量：15
  • 2U.S. Department of Health and Human Services FDA Center for Drug Evaluation and Research, U. S. Department of Health and Human Services FDA Center for Biologics Evaluation and Research, U.S. Department of Health and Human Services FDA Center for Devices and Radiological Health. Guidance for industry: patientreported outcome measures: use in medical product development to support labeling claims: draft guidance. Health Qual Life Outcomes. 2006; 4: 79.
  • 3Patient Reported Outcomes Harmonization Group. Harmonizing patient reported outconles issues used in drug development and evaluation[2008-05-01]. http:// www. eriqa-project.com/pro-armo/home. html.
  • 4Levin iS, Glass TA, Kushi LH, et al. Quantitative methods in research on complementary and alternative medicine. A methodological manifesto. NIH Office of Alternative Medicine. Med Care. 1997; 35(11): 1079-1094.
  • 5Emery MP, Perrier LL, Acquadro C. Palienl-reported outcome and quality of life instruments database (PROQOLID): frequently asked questions. Health Qual Life Outcomes. 2005, 3: 12.
  • 6Lee P. Dear eDiary - more reliable, and less costly, electronic patient diaries are gaining favor. Pharm Exec. 2005; (6): 20 23.
  • 7Ware JE, Jr. Scales for measuring general health perceptions [J]. Health Serv Res, 1976, 11 (4): 396- 415.
  • 8Guidance for industry: patient-reported outcome measures: use in medical product development to support labeling claims: draft guidance [ J ]. Health Qual Life Outcomes, 2006, 4:79.
  • 9Fung CH, Hays RD. Prospects and challenges in using patient-reported outcomes in clinical practice [J]. QualLife Res, 2008, 17(10);1297-1302.
  • 10Calkins DR, Rubenstein LU, Cleary PD, et al. Failure of physicians to recognize functional disability in ambulatory patients [J]. Ann Intern Med, 1991, 114 (6) :451-454.

共引文献133

同被引文献67

  • 1唐·孙思邈.备急千金要方[M].北京：人民卫生出版社,1982..
  • 2山东中医学院,河北医学院校释.黄帝内经素问校释[M].北京:人民卫生出版社,1982.2.27.420.
  • 3Wilke R J, Burke L B, Erickson P. Measuring treatment impact: a re- view of patient-- reported outcomes and other efficacy endpoints in ap- proved product labels[J]. Control Clin Trials, 2004,25 :535--552.
  • 4Acquadro C, Berzon R, Dubois D, Leidy N K, et al. PRO Harmo- nization Group: Incorporating the patient's perspective into clrug de- velopment and communication: an ad hoe task force report of the Patient--reported Outcomes(PRO) Harmonization Group meeting at theFood and Drug Administration, February 16,2001[J]. Value in Health,2003,6(5) :522--531.
  • 5The ERIQA Group: Assessing Treatment Impact Using Patient--Reported Outcomes (PROs) : Challenges in Study Design, Conduct and Analysis. Meeting Report (Paris, May 10--11, 2004)[J]. Pa- tient- Reported Outcomes Newsletter, 2005, 3(Special) : 1-- 16.
  • 6U.S. Department of Health and Human Services, FDA, Center for Drug Evaluation and Research, Center for Biologics Evaluation and Re- search, Center for Devices and Radiologieal Health. Guidance for Indus- try--Patient Reported Outcome Measures: Use in Medical Product De- velopment to Support Labeling Claims[EB/OL]. (2009--03--07)[2011 12-- 121. http://www, hqlo. corn/content/4/1/79.
  • 7Lynda C Doward, Ari Gnanasakthy, Mary G Baker. Patient repor- ted outcomes: looking beyond the label claim. Health and Quality of Life Outcomes[J]. Health Qual Life Outcomes, 2010,8:89.
  • 8Clare Bradley. Feedback on the FDA's February 2006 draft guid- ance on Patient Reported Outcome (PRO) measures from a devel- oper of PRO Measures[J]. Health and Quality of Life Outcomes, 2006,4:78.
  • 9Department of Health. Our Health, Our Care, Our Say: A New Direction for Community Services[J]. White Paper, London , 2006:1--236.
  • 10Leong K P, Chong E Y, Kong K O, et al. Tan Tock Seng Hospital (TTSH) Lupus Study Group: Discordant assessment of lupus ac- tivity between patients and their physicians: the Singapore experi- ence[J]. Lupus,2010,19(1) :100--106.

引证文献9

二级引证文献51

医学与哲学（A）
2011年 第1期

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