谈谈中国临床试验研究中受试者权益保障问题

随着国家《药品临床试验管理规范》的颁布与实施,我国新药临床试验研究水平有相当的提高,但也存在着一些问题。其中包括保护受试者权益问题。国家GCP有关章节中明确指出要保护受试者权益。并有具体规定,但在执行中尚有出入,如试验方案未经伦理委员会批准,未向受试者告知试验内容。或告知的不够充分,甚至在未签署知情同意书时就开始试验等。为此,我国采取了相应的措施,如设立药品临床研究培训中心;定期对临床试验基地的研究者以及相关人员如与试验有关的医师,药师及申办者进行GCP培训,基地审核制度,以法律手段来保证受试者权益等。     

发挥生物医学期刊在临床试验知情同意督查中的作用

通过对近10年我国临床医学研究人员忽视知情同意现状的分析,以《纽伦堡法典》、《赫尔辛基宣言》等国际公认的法规和准则,以及1998年以来我国相继颁布、完善、实施的《涉及人的生物医学研究伦理审查办法（试行）》、《药物临床试验质量管理规范》、《临床药理基地管理指导原则》、《中华人民共和国执业医师法》等相关的法律、法规、原则、规范以及伦理道德为依据,探讨生物医学期刊如何在临床试验知情同意督查中发挥应有的作用。     

药物临床试验中科学原则、法规原则与伦理原则的权重与取舍

药物临床试验既要符合伦理学原则、法规原则,又要具备科学原则.伦理学原则要求受试者最大程度受益和尽可能避免伤害.在法规原则上也首先强调的是受试者的权益,然而试验设计的科学性原则有很多时候却对伦理学提出了挑战.当药物临床试验的科学性、法规性与伦理性发生矛盾时,我们应把伦理问题摆在首位.     

对药品临床试验的伦理性与科学性的思考

药物临床试验首先要符合伦理学原则,同时又必须具备科学性。伦理学原则要求受试者最大程度受益和尽可能避免伤害。随机、双盲对照的方法在保障科学性的同时,对伦理学提出了挑战。     

对药品临床试验的伦理性与科学性的思考

药物临床试验首先要符合伦理学原则,同时又必须具备科学性.伦理学原则要求受试者最大程度受益和尽可能避免伤害.随机、双盲对照的方法在保障科学性的同时,对伦理学提出了挑战.     

临床试验安全性均势伦理探讨

均势原则是临床试验中的一项方法规则,同时也是临床试验研究的伦理规则。均势原则指导下的临床试验仍然存在设计缺陷、忽视安全风险评估、均势判定主体失当等方面的安全性伦理问题。这需要进一步确立安全性均势伦理准则,以强调在临床均势试验研究中不能对受试者造成生命健康方面的明显伤害,包括风险受益全面合理性评估原则、受试者生命安全底线原则以及利益相关者安全责任原则。落实安全性均势伦理原则需要采取多学科协作评估、优化均势判定主体结构及明确判定标准等基本规范策略。     

临床试验的科学性和伦理问题

提出了临床试验中7种不符合伦理的情况,并以实例说明.同时介绍了符合伦理的临床试验的一种新的设计方法--动态设计以及实施动态设计所需要建立的独立数据检查委员会.最后讨论了动态设计的中文译名.     

新药临床试验中安慰剂的使用与伦理思考

新药临床试验中使用安慰剂是一个颇具争议的问题.结合国内外的研究情况,通过具体实例阐述了安慰剂的作用和机理,并讨论如何解决临床试验中与安慰剂设置有关伦理学的问题,旨在为我国临床试验制定相应的指导原则和标准提供参考.     

随机临床试验中伦理问题的探讨

随着我国的药物临床试验过程逐渐完善,药物临床试验水平不断提高,但伦理学方面并不十分完善.临床研究者和受试者应该明确自己的权益和义务,并在药物随机临床试验中,使受试者的权益得到更好的保护.本文论述并总结了药物临床试验中出现的问题,并提出了改进措施.     

病毒性肝炎临床试验使用安慰剂的伦理学问题

１　临床试验的医德原则医学的进步是以研究为基础的,而研究的最终过程在一定程度上均有赖于以人类为对象的实验。临床试验是以治疗为目的的医学研究;也是新药得以批准正式使用前所必须完成的重要步骤。当前,绝大多数治疗措施均有一定风险。因此,治疗研究必须在保证不...     

Principles of good clinical practice (GCP) in clinical research

Good Clinical Practice is an international quality standard for conducting trials that involve participation of human subjects. Currently, the most widely accepted international document forming the base for GCP is the ICH Harmonised Tripartite Guideline for GCP, which defines in detail the responsibilities and obligations of parties engaged in clinical research. The purpose of this paper is to analyse how compliance with GCP provides protection of the trial subjects and assures quality and credibility of the data obtained. An earlier version of this paper was presented at a symposium, Scientific Misconduct: An International Perspective, organised by The Medical University of Warsaw, 16 November, 1998.     

Cognitive factors and willingness to participate in an HIV vaccine trial among HIV-positive injection drug users

There are gaps in our knowledge of the role cognitive factors play in determining people's willingness to participate (WTP) in therapeutic HIV vaccine trials. Using a cross-sectional study of HIV-positive injection drug users (IDU), we determined the role of three cognitive factors: HIV treatment optimism, self-efficacy beliefs, and knowledge of vaccine trial concepts in relation to WTP in a hypothetical phase 3 therapeutic HIV vaccine trial. WTP was 54%. Participants tended to be low in HIV treatment optimism (mean?=?3.9/10), high in self-efficacy (mean?=?79.8/100), and low in knowledge (mean?=?4.1/10). Items pertaining to HIV treatment optimism and knowledge of HIV vaccine trial concepts were generally unrelated to WTP. An increase in self-efficacy had a statistically significant positive association with WTP (OR?=?1.61, 95% CI?=?1.04-2.46, p?相似文献   

Le vaccin,un médicament devenu l’arme absolue promise contre la COVID-19 : une réglementation adaptée ?

As the first vaccines against COVID-19 arrive on the market, the question of the safety of these products arises in the public debate. The major concern is about the possible occurrence of adverse effects, particularly in the context of the use of novel pharmaceutical technologies such as mRNA. It is important to remind both patients and professionals that a vaccine is not only a medicinal product in its own right, but also a special medicinal product: biological and immunological. As a result, its supervision is draconian, and despite the urgency, no requirements have been lowered. The speed of marketing is the result both of adapted clinical trials and optimized evaluation procedures.     

A call to restructure the drug development process: Government over-regulation and non-innovative late stage (Phase III) clinical trials are major obstacles to advances in health care

The history of drug/vaccine development has included major advances guided primarily by risk/benefit analyses concerning the innovative agent, not by evidence-based clinical trials (Phase I–IV). Because the approval for new drugs is hindered under the present process, the system requires restructuring. The Phase I/II study period should be more flexible, using the “environment of knowledge” about the new agent, plus risk/benefit assessments. Phase III, as presently constructed, does not add new adverse events data, it provides a narrower profile of drug efficacy than properly done Phase II studies, and placebo-controlled trials continue to raise unresolved ethical and social issues. Phase III studies should be abandoned for most drugs, and substituted with properly powered Phase II doseranging studies plus careful post-marketing surveillance. Phase III should be a penalty for poor drug development, not a regulatory requirement. To accomplish efficient drug development, greater cooperation between pharmaceutical companies and governments in developing clinical trials is needed rather than over-regulation. These changes will synchronize the drug development and regulatory process with the current rapid drug discovery process, reduce drug development time and cost, and improve patient care. The author is Adjunct Professor of Medicine, Weill Medical College of Cornell University, New York, New York, USA.     

优化乙肝治疗方案真实评价治疗效果

目前乙肝治疗比较混乱,给患者带来许多损失,优化乙肝治疗方案,是从患者病情出发,实施个体化治疗,目标是安全、有效、经济和适度,处于抗病毒最佳时机的患者可以考虑使用干扰素或拉米夫定;乙肝病毒携带者暂时禁止使用药物治疗;急性乙肝只给与基本治疗,待其自愈.实施优化方案,杜绝各种各样的商业广告;凡是尝试性治疗,一律按照新药临床验证程序进行,一律实行免费.治疗乙肝的疗效最终取决于持久、完全效应,不应局限在病毒阴转或肝功正常上.     

Relative versus absolute standards for everyday risk in adolescent HIV prevention trials: expanding the debate

The concept of minimal risk has been used to regulate and limit participation by adolescents in clinical trials. It can be understood as setting an absolute standard of what risks are considered minimal or it can be interpreted as relative to the actual risks faced by members of the host community for the trial. While commentators have almost universally opposed a relative interpretation of the environmental risks faced by potential adolescent trial participants, we argue that the ethical concerns against the relative standard may not be as convincing as these commentators believe. Our aim is to present the case for a relative standard of environmental risk in order to open a debate on this subject. We conclude by discussing how a relative standard of environmental risk could be defended in the specific case of an HIV vaccine trial among adolescents in South Africa.     

晚期乳腺癌如何选择内外科治疗

晚期乳腺癌包括局部病变较晚、无法直接手术的患者和初诊时已有远地转移M1及手术后的复发转移患者。目前,我们国家对于这些患者的处理非常混乱,往往初始治疗与首次接诊医生的专业范围大有相关。孤立病灶的晚期乳腺癌患者,全身播散背景已成定势,全身药物治疗才是最重要的治疗手段。对于已经全身转移的晚期乳腺癌患者来讲,是否加用局部病灶切除,需根据患者的全身情况而定。任何一种治疗的选择及安排都应按照药品临床试验管理规范（GCP）原则进行,以期最大限度改善生活质量及生存时间。     

Emerging therapeutics for Alzheimer's disease: an avenue of hope

Emerging therapies for Alzheimer's disease offer hope to patients and their caregivers. Future treatments will probably include combination approaches with agents that modify amyloid processing, deposition, and clearance. One example, the AD vaccine, reduced amyloid burden and changed behavior in animal models of AD, but the human trial was halted when several subjects developed brain inflammation. Anti-inflammatory agents have epidemiologic support, but clinical trials have been disappointing, possibly related to inadequate study with anti-inflammatory agents that modify amyloid processing. Agents that target known cardiovascular risk factors, such as hypercholesterolemia, hypertension, and insulin resistance, have epidemiologic, preclinical, and clinical evidence to warrant further investigation. Heavy metal chelators, antioxidants, neurotrophic factors, glutaminergic modulators, and agents that modify hyperphosphorylation of Tau are other approaches in research and development.