关于药物临床试验伦理问题的思考

医学伦理学是伴随着科学技术的发展而产生的事物,药物临床试验在促进人类健康事业发展的同时,也涉及到与之相驳的伦理学问题,运用哲学的矛盾原理,浅析药物临床试验与医学伦理之间存在的矛盾及矛盾的两面性,以求解决目前药物临床试验中遇到的困难和问题。     

药物临床试验信息公开研究

在对政府药物临床试验信息公开现状分析的基础上,根据与公众利益、与申办人利益和公开效益成本比在法理上确定了药物临床试验的公开范围,并建议完善政府信息公开指南、扩大公开范围以及促进申办人主动公开等确保信息公开、公平、便民.     

关于药物临床试验伦理问题的思考

医学伦理学是伴随着科学技术的发展而产生的事物,药物临床试验在促进人类健康事业发展的同时,也涉及到与之相驳的伦理学问题,运用哲学的矛盾原理,浅析药物临床试验与医学伦理之间存在的矛盾及矛盾的两面性,以求解决目前药物临床试验中遇到的困难和问题.     

药物临床试验设计的伦理思考

目前广泛采用的药物临床试验设计中,由于不能使受试者最大限度的受益而在伦理学方面存在弊端。自适应设计方法的出现,为克服这一弊端提供了现实途径,可使药物临床试验的受试者能够最大程度的受益。本文从传统临床试验引发的伦理问题入手,阐述了自适应设计以人为本的特点,探讨了其在解决伦理与疗效冲突问题中的重要作用。     

药物临床试验伦理审查的跟踪审查程序研究

为了保护受试者的合法权益,药物临床试验的伦理审查必须规范化进行.通过走访哈尔滨医科大学附属医院伦理委员会了解到,伦理审查程序缺乏相对完整性,特别是跟踪审查程序还在完善过程中,没有形成统一具体的操作规程.对此,结合我国实际情况,借鉴国外先进经验,提出构建药物临床试验跟踪审查程序的建议.     

未成年人参与药物临床试验的法律问题研究

通过论证未成年人参与药物临床试验的必要性,介绍与比较英国、德国、美国和澳大利亚等国对未成年人参与药物临床试验的立法规制,对我国相关立法状况进行分析,认为我国应修改《药物临床试验质量管理规范》等法律文件,要求研究者考察未成年受试者同意能力的发展状况、明确伦理审查的标准和引入风险利益评估体系。     

未成年人参与药物临床试验的法律问题研究

通过论证未成年人参与药物临床试验的必要性,介绍与比较英国、德国、美国和澳大利亚等国对未成年人参与药物临床试验的立法规制,对我国相关立法状况进行分析,认为我国应修改<药物临床试验质量管理规范>等法律文件,要求研究者考察未成年受试者同意能力的发展状况、明确伦理审查的标准和引入风险利益评估体系.     

药物临床试验伦理委员会规范化管理的探讨——广州军区广州总医院的经验

针对以往本院药物临床试验伦理委员会伦理评审工作中存在的一些常见问题及目前伦理委员会的工作情况,提出了应依据<药物临床试验管理规范>来加强完善伦理委员自身建设,规范伦理审查过程.同时根据自身的经验为促进伦理委员会的科学规范发展提出了几点体会和建议.     

药物临床试验中民事责任探析

药物临床试验是由申办者、研究者和受试者共同参与的一项实验性医疗行为.申办者与研究者应当对受试者因试验引起的不良后果承担共同民事责任.其中,因研究者的过错造成的损害后果,申办者也要基于安全保障义务承担补充责任.补充责任的承担有利于受害人的顿害能得到及时完全的赔偿.     

医学研究者的经济利益冲突对临床试验的影响——美国的经验与启示

研究者的经济利益冲突对医学临床试验可能会产生消极影响。本文依据美国的研究成果,利用大量的统计数据和真实的案例,分析了研究者在临床试验中的主要经济利益,揭示了这些经济利益如何对研究的设计、执行和报告产生影响,以及可能造成的危害。     

From Standardization to Adaptation: Clinical Trials and the Moral Economy of Anticipation

Hailed as the gold standard, the randomized controlled trial (RCT) occupies a hegemonic position at the top of evidence-based medicine’s hierarchy of knowledge. It is testament to the methodology’s capacity for standardization that it can so readily be spoken of in the singular: the RCT. Under what conditions, then, is it possible to speak of change in the gold standard? Since the 1950s, alternative versions of the RCT have been advocated for under the banner of ‘adaptive design’. Adaptive designs allow investigators to make pre-planned changes to a trial on the basis of accruing information while the experiment is ongoing. Initially a niche topic of methodological debate among biostatisticians, the approach is becoming widespread in mainstream drug development. A genealogical analysis exposes the discursive moves used to justify and popularize adaptation, from a focus on patient well-being and the greater good in the 1960s and 1970s, to efficiency and virtualism in the 1990s and 2000s. Changing discourses of time and patienthood have facilitated a move away from standardization as the singular logic of trials towards an appreciation of flexibility, undergirded by probabilistic methodologies. Adams et al.’s [(2009). Anticipation: Technoscience, life, affect, temporality, Subjectivity, 28, pp. 246–265] conceptual framework of anticipation illuminates this evolving moral economy of medical research, in which modes of knowledge production which claim to know the future are supplanting the traditional certainties of fixed and standardized experimental designs. Predictable uncertainty is the currency of this emerging economy, which capitalizes on computer simulation and ever more sophisticated tools of prediction to leverage credibility.     

Uncertainty and the Ethics of Clinical Trials

A probabilistic explication is offered of equipoise and uncertainty in clinical trials. In order to be useful in the justification of clinical trials, equipoise has to be interpreted in terms of overlapping probability distributions of possible treatment outcomes, rather than point estimates representing expectation values. Uncertainty about treatment outcomes is shown to be a necessary but insufficient condition for the ethical defensibility of clinical trials. Additional requirements are proposed for the nature of that uncertainty. The indecisiveness of our criteria for cautious decision-making under uncertainty creates the leeway that makes clinical trials defensible.     

急性心肌梗死治疗的临床试验分析

急性心肌梗死是冠心病中的危重症,病死率高。为在现有基础上进一步降低病死率,临床开展了众多针对各治疗策略的大型试验研究。在分析这些临床试验的基础上,从提高梗死血管开通率、改善心肌微循环灌注、挽救心肌和休克治疗四个方面综述了各种治疗策略的优势及不足,以期对临床治疗方案的选择起到借鉴作用。     

Methodological Strategies in Child Clinical Trials: Advancing the Efficacy and Effectiveness of Psychosocial Treatments

The present paper reviews issues of treatment efficacy (i.e., potency) and effectiveness (i.e., clinical utility) in applied clinical child research. Threats to treatment evaluation are reviewed in the context of these two dimensions. It is proposed that treatment outcome research faces new challenges stemming from the ever increasing emphasis on generalization of gains and dissemination of interventions outside of clinical research settings. Issues and approaches proposed as warranting further development and attention include development, flexibility, acceptability, and disseminability of psychosocial assessment and treatment methods. A research emphasis is promoted that balances experimental control with the need for treatment generalization and delivery outside of the research setting, in order to maximize the utility of clinical research.     

儿童不明原因晕厥的临床决策分析

目前,罹患不明原因晕厥的儿童逐渐增多,临床上对于此病并不好诊断;介绍目前国内外对于儿童不明原因晕厥的诊断方案,分析了儿童不明原因晕厥的临床决策,并对不同的治疗方案进行了分析和讨论,提出了个体化治疗,针对不同病情的患者应采取不同的治疗方案;总结了如何提高医学工作者的临床决策水平。     

现代复苏的药物应用现状的理性思考

回顾了复苏药物应用研究的现状,运用创新思维的科学方法对现代复苏药物临床应用研究中的医学和伦理难题进行了理性分析,阐明了理论,逻辑思维,哲学思考对临床实践和医学研究的重要性。     

国际多中心药物试验伦理审查中的冲突与防控策略

国际多中心药物临床试验既包括新药上市前的临床试验, 也包括对药物上市使用后所做的进一步研究, 以证实或揭示试验用药物的作用, 不良反应及其吸收、分布、代谢和排泄的规律。其发展折射着全球化进程在医药卫生领域的快速发展, 目前我国的国际多中心药物临床试验日渐增多, 伦理审查中出现的伦理冲突也愈发明显, 主要表现在伦理标准、试验参与各方的利益、本地化和国际性、审查的质量差异、试验方法与伦理原则等方面。对此, 应提高各中心伦理委员会的素质和能力;注重协调各中心利益;加强中心之间的有效沟通。     

Alter-Standardizing Clinical Trials: The Gold Standard in the Crossfire

ABSTRACT

The international landscape of medical research is in the midst of a process of diversification and change. The randomized controlled trial (RCT), long considered the global gold standard for clinical research, has become increasingly contested and is partly replaced by alternative methodologies, standards and forms of evidence. The contours of mainstream medical research are changing as a result. Regulatory paradigms and standards are, literally, being rewritten, at a global level. The evidence-based medicine (EBM) hierarchy of evidence is redefined. This special issue explores these developments through the concept of ‘alter-standardization’. The term refers to the processes, controversies and negotiations through which multiphase RCTs and the EBM system are challenged and gradually superseded by alternative methodological and regulatory forms and standards. This special issue examines the conceptual, practical and theoretical implications of these changes, and the ways in which these transformations influence the situation and possibilities of patients, knowledge producers, physicians, large pharmaceutical corporations, smaller biotech companies, as well as regulatory bodies, civil societal organizations and national health care systems. The articles in this special issue make use of comparative and historical perspectives that focus on scientific, social, economic and regulatory developments in the European Union, China, India, Japan, Argentina, the UK and the USA. They show that the alter-standardizing of clinical trials arises in a pluralistic way, that is driven by a variety of often conflicting factors, developments and expectations. These changes reflect a broad transformation in the culture and politics of biomedicine today, with implications for the ways in which new medicinal products, devices, procedures and technologies are developed, approved for clinical use, sold to consumers, and licensed by health care systems.     

How Civil Society Organisations Changed the Regulation of Clinical Trials in India

ABSTRACT

In 2005 India changed its pharmaceutical and innovation policy that facilitated a dramatic increase in international clinical trials involving study sites in India. This policy shift was surrounded by controversies; civil society organisations (CSOs) criticised the Indian government for promoting the commercialisation of pharmaceutical research and development. Health social movements in India fought for social justice through collective action, and engaged in normative reasoning of the benefits, burdens and equality of research. They lobbied to protect trial participants from structural violence that occurred especially in the first 5–6 years of the new policy. CSOs played a major role in the introduction of new regulations in 2013, which accelerated a decline in the number of global trials carried out in India. This activism applied interpretations of global social justice as key ideas in mobilisation, eventually helping to institutionalise stricter ethical regulation on a national level. Like government and industry, activists believed in randomised controlled trials and comparison as key methods for scientific knowledge production. However, they had significant concerns about the global hierarchies of commercial pharmaceutical research, and their impact on the rights of participants and on benefits for India overall. Pointing to ethical malpractices and lobbying for stricter ethical regulations, they aimed to ensure justice for research participants, and developed effective strategies to increase controls over the business side of clinical research.