医疗机构中医疗器械临床试验的伦理审查

医疗器械临床试验是对医疗器械的安全性和有效性按照规定进行试用或验证的过程,该过程需由具有医疗器械临床试验资格的医疗机构审核．经其医学伦理委员会评审通过后,方可进行。对医疗机构中医疗器械临床试验伦理审查的内容,流程和批准标准分别进行了分析和评述．为医疗机构保证临床试验的安全有效提供依据。     

医院医疗器械临床试验数据核查中常见问题及改进措施

目的:医疗器械临床试验数据结果的真实性和准确性是试验产品有效、安全的可靠保障。本文拟通过分析医院既往医疗器械临床试验数据核查中出现的问题,总结经验并提出解决措施。方法:根据《医疗器械临床试验检查要点及判定原则》,笔者回顾性分析2016年至今医院医疗器械临床试验的数据核查情况,对核查的常见问题进行归纳与原因分析。结果:医...     

两阶段设计在医疗器械非随机临床试验中的应用

目的介绍两阶段设计的概念、使用流程和注意事项,并以某外周血管支架临床试验为例介绍其在医疗器械非随机临床试验中的应用。方法基于倾向性评分的两阶段设计能使医疗器械非随机临床试验满足随机化和前瞻性的原则。我们以某外周血管支架的非劣效试验为例,介绍两阶段设计的流程和细节。结果两阶段设计解决了非随机临床试验由于非随机所带来的可能的研究偏倚及倾向性评分方法使用过程中的主观不确定性,实现了对随机临床试验的模拟,从而保障了非随机临床试验研究设计和统计分析的客观性和前瞻性。结论两阶段设计能够增加临床试验的可行性,整合高质量的外部数据,缩短试验周期,提高试验效率,最终得到可靠的结论,具有较大的推广价值。     

我国医疗器械注册审批中临床试验管理研究

我国医疗器械注册审批中,因临床试验而影响注册审批速度。通过与欧美医疗器械临床试验比较,总结我国医疗器械在临床试验中存在的一些问题并以具体实例加以分析,提出解决我国临床试验问题的相关建议。     

医疗器械临床试验概述

国际上对医疗器械临床试验非常重视，ISO专门制定了医疗器械临床试验标准（ISO14155.1和2）。美国FDA在1996发布了GCP指南，欧共体在2003年发布了医疗器械临床数据评价；制造商和授权机构（NB）指南）MEDDEV.2.7.1）在这些标准或指南中，对医疗器械临床试验方案及数据处理进行统计学分析有原则要求。     

临床试验的适应性设计

目的介绍临床试验适应性设计概念和具体使用方法,使读者对临床试验适应性设计有一个初步的认识。方法通过实例介绍临床试验适应性设计的基本思想和概念。结果阐述临床试验适应性设计与成组序贯方法间的异同点,同时介绍在适应性设计中,如何体现临床试验的两个基本的统计学原则。结论适应性方法给临床试验设计带来了很大的灵活性,可以更大程度地提高研究工作的效率。     

医疗器械临床试验开展过程中知情同意认知现状

随着科学技术的快速发展,医药产业高速前进,医疗器械在疾病的防控、诊断及治疗中的应用越来越广泛,与药品相比,医疗器械有复杂的设计及构造,临床试验在探索医疗器械安全性及有效性的同时,其试验风险远高于一般临床诊疗,作为试验对象的受试者承担着不可预见的风险,故对其相关权益保护的研究意义重大。文章通过研究国家药政部门管理平台及知网和维普等数据库获取国内外关于医疗器械临床试验受试者权益保障的最新政策法规及现状,来探讨医疗器械临床试验开展过程中知情同意认知现状,主要包括临床试验知情同意书设计的缺陷、知情同意书签署不规范、研究医生的认识不足、法定代理人的签署不规范等4个方面,对其存在的问题进行分析和归纳,对医疗器械临床试验的特殊性认识进行分析,并提出了相应对策以保护受试者权益,为后期医疗器械临床试验设计和实施提供理论参考。     

医院医疗器械临床试验的特点及管理对策

该文通过分析中山大学附属第三医院近10年完成的医疗器械临床试验的一般资料,结合临床试验过程中的管理经验,对我院医疗器械临床试验的特点及存在问题进行阐述,并提出相应的管理对策以保证医疗器械试验的质量,提高医院对医疗器械临床试验管理的规范性。     

我院医学伦理委员会运行实践

医院的医学伦理工作是在医学道德框架下进行的.1971年,加拿大<医德指南>首先提出了建立医院伦理委员会的建议.而第一个伦理委员会也于1974年诞生于美国[1].在科学研究、临床实践和其他医学活动中,都体现了伦理价值和道德追求.医学伦理的基本原则是不伤害原则、有利原则、尊重原则、公正原则.医学研究是利用人类已掌握的知识和工具,以人体和其他生物体为研究对象,用试验研究、临床观察、社会调查分析等方法探求人类生命自身活动的本质和规律以及与外界环境的相互关系,揭示疾病发生发展的客观过程,探寻防病治病、增进健康的途径和方法的探索活动[2]141.其中,直接以人体作为受试对象的医学研究始终面对着生命伦理学中的"两难问题"."两难问题"是一个技术词汇,即由两个前提所得出的结论通常是一种令人不快的二者择一的选择[3].医学伦理委员会由此产生,通过审核、讨论,以最大限度地避免不合理的选择,并对符合伦理的行动提出建议.     

医疗器械临床试验中发现的问题及改进措施

回顾性总结了某院2015—2019年开展的17项医疗器械临床试验质控中发现的问题,从研究者、申办方、药物临床试验机构办公室、国家法规4个角度分析了问题产生的原因.结合医疗器械临床试验现状提出加强对研究者的培训、强化申办方角色、建立完善的质量控制体系及完善相应法规的改进措施,为医疗器械临床试验的管理者和实施者提供了参考.     

Ethics of clinical trials in family medicine

In this paper several issues are examined that arise from conducting randomized clinical trials in a family practice setting. The distinctive research tradition in family practice involves a patient's primary care physician performing an experimental investigation that usually, though not invariably, is focused on common health problems. Representative clinical trials are presented as examples that illustrate two ethical difficulties evoked by such research: a potential violation of the primary care physician's therapeutic imperative to provide the best possible treatment for his or her patient, and the likelihood that the type of physician-patient relationship fostered in family practice significantly diminishes the capacity of the patient to give true informed consent. In an attempt to resolve these ethical difficulties, a model of moral reasoning is presented that is based on easily understood ethical principles and is applicable to actual clinical decision making. Using that model, a tentative set of rules or guidelines is offered for implementing clinical trials in family medicine.     

Paradigm shift, metamorphosis of medical ethics, and the rise of bioethics

Both the increasing incorporation of medical technology and new social demands (including those for health care) beginning in the 1960s have brought about significant changes in medical practice. This situation has in turn sparked a growth in the philosophical debate over problems pertaining to ethical practice. These issues no longer find answers in the Hippocratic ethical model. The authors believe that the crisis in Hippocratic ethics could be described as a period of paradigm shift in which a new set of values appears to be emerging. Beginning with the bioethics movement, the authors expound on the different ethical theories applied to medical practice and conclude that principlism is the most appropriate approach for solving the new moral dilemma imposed on clinical practice.     

Ethical reasoning and decision-making in the clinical setting: assessing the process

Clinical ethical reasoning and analysis are skills as central to good patient care as the efficient application of biomedical knowledge to diagnosis and prognosis. However, experience in teaching clinical ethics to senior medical students has indicated that simply trying to ‘apply’ the knowledge learnt about ethical theories, principles, concepts and rules in the clinical setting does not ensure ethical competence in clinical decision-making. In 1992, we developed and piloted a three-session programme that focused on a more systematic approach to the way students identified and attempted to manage ethical issues in their clinical practice. This programme was modified and improved in 1993 and further expanded in 1994. Our experience suggests that many students are now better able to bridge what has been called the ‘gap’ between the possession of ethical knowledge and its actual use in clinical decision-making. The remaining problem was assessment. How do you assess clinical ethical reasoning and decision-making? In the preclinical years of medical education, knowledge-based assessment tools, like the modified essay question (MEQ), provide a means for assessing the sensitivity of students to ethical issues. However, such tools permit neither an appraisal of how students actually make clinical ethical decisions, nor which factors students perceive as important in making an actual clinical decision. In order to make this type of appraisal, we developed a format for a written case report that facilitated our assessing the process as well as the end-product, the decision. The results obtained from the use of the written case report in the annual assessment of our senior medical students in 1993, while encouraging, also identified a number of unexpected problems.     

医院医疗设备管理的几个问题及对策

本文从重复购置、等级评定片面、设备闲置、随意报废4个方面 ,对当前医院设备管理中存在的这几个较为突出的问题 ,详细介绍并相应提出解决对策     

Challenge to international agencies.

International health agencies face major changes requiring basic adjustments in approaches and values. The ethical issues include moral criteria for allocating scarce resources, relation of health to population growth and development, iatrogenic social consequences of health measures, and inappropriate transfer of technology. A proposed new style of international health work is summarized in five principles and ten guidelines. The principles are: development from below; a role shift from adviser collaborator; sequential research, demonstration, and implementation; concentration on problems of motivation; and parternship in approaches to mutually shared complex problems.     

Research Participation as Work: Comparing the Perspectives of Researchers and Economically Marginalized Populations

We examined the historical and regulatory framework of research with human participants in the United States, and described some possible unintended consequences of this framework in the context of paying young injection drug users for their time participating in behavioral and medical research. We drew upon our own experiences while conducting a long-running epidemiological study of hepatitis C virus infection.We found that existing ethical and regulatory framings of research participation may lead to injustices from the perspectives of research participants.We propose considering research participation as a specialized form of work and the use of community advisory boards to facilitate discussion about appropriate compensation for research participation among economically marginalized populations.AS RESEARCHERS, OUR CONstructions of what is and what is not “ethical research” have been heavily informed by our knowledge of the terrible ethical failures of members of our tribe within the past 70 years—the willing participation of some scientists in human experimentation on the victims of the Holocaust, the Tuskegee experiment, Willowbrook, the Milgram experiments, and numerous other large and small abuses of human beings. Responses to these horrors, such as the Nuremberg Code, the Declaration of Helsinki, the Belmont Report, and their derivative processes, protocols, and laws have all sought to describe and codify what comprises ethical research, and in doing so prevent future abuses. In the United States, the most important of these has been the 1979 Belmont Report, a product of the then–US Department of Health, Education, and Welfare. The Belmont Report enshrines 3 principles for research: respect for persons (protecting the autonomy of all people and treating them with courtesy and respect and allowing for informed consent), beneficence (maximizing benefits for the research project while minimizing risks to the research participants), and justice (ensuring reasonable, nonexploitative, and well-considered procedures are administered fairly).1 The policy approach described in the Belmont Report is largely implemented in US law through Title 45 (Public Welfare), Part 46 (Protection of Human Subjects) of the US Code of Federal Regulations (hereafter 45 CFR 46), which provides minimum standards required for federally funded research involving human participants.Taken as a whole, 45 CFR 46 and the history behind it create what the sociologist Erving Goffman referred to as a “frame,” a way of ordering and making sense of a situation that has consequences for how we understand subsequent events.2 A simple example of how framing can have a significant impact on the way an individual understands an event can be seen in a common medical procedure such as a testicular or cervical examination: a relative stranger asks the individual to disrobe, then views and even handles the individual’s genitals. Under almost any other circumstance, this would be experienced as a violating and even traumatic event because the individual would understand the process as an assault. However, because the event happens within a framework shared by both participants, one that locates the medical practitioner as someone acting in the best interests of the individual’s health, and the individual as someone who has sought out the examination for the benefit of his or her health, such an examination is rarely more than mildly discomforting. In the case of 45 CFR 46, the code likewise contains a number of elements that together act to create a frame that shapes how researchers and institutional review boards (IRBs) interpret and understand situations that arise in the course of research involving human participants.We describe possible unintended consequences of this framework in the context of conducting research with young, economically marginal users of illicit drugs. This article is drawn from our experience conducting research with young injection drug users in San Francisco over a 12-year period.     

Public-Health-Ethik in Abgrenzung zur Medizinethik

Until now there are only a few approaches in the German-speaking realm to establish an explicit ethical framework for moral issues of public health--although a need for public health ethics in times of SARS and avian flu is obvious. One deficit of the discussion so far is that there is no systematic separation of medical ethics and public health ethics. Thus, the core and interdisciplinary focus of public health is often not met. However, to frame discussions of moral issues within a specific public health ethics framework seems to be fruitful. This paper deals with the conceptual differences of medical ethics and public health ethics. The discussion helps both applied ethical discourses to sharpen their focus and strengthen their appeal. The author develops and presents a conceptual and normative frame for public health ethics and offers a concise set of ethical principles for the discussion of moral challenges in public health.     

医疗设备质量安全控制的区域合作

由于医疗设备质量安全控制过程中需要配备相应的专业人员、设备与资金等,所以各地区与各医院之间临床工程人才、检测设备等存在分布不平衡的现象,为医疗设备质量安全控制的广泛深入开展带来困扰,而区域合作可以有效解决这一问题。本文结合目前国内实际,从区域性合作的必要性、目标、主要模式、面临的问题等几个方面对医疗设备质量安全控制进行探讨。