国际多中心临床试验的护理管理

该文从研究护士的选择及培训、试验药物管理、受试者管理3个方面阐述抗肿瘤药物国际多中心临床试验的护理管理工作,以期建立国际多中心临床试验护理工作的规范化、科学化管理体系。     

国际多中心临床试验在中国

文章综述了药物临床试验在国内外的发展概况，剖析了中国在开展国际多中心临床试验中具备的优势及面临的机遇与挑战，并就如何在中国开展国际多中心临床试验提出相关的建议和对策。     

多中心临床试验(二)--统计分析

生物统计学（Ｂｉｏｓｔａｔｉｓｔｉｃｓ）是运用数理统计原理,结合医学、生物学实际,研究数字资料的收集、整理、分析和推断的一门学科,它是进行临床试验所必需的重要手段。生物统计学的主要内容有统计研究设计,统计描述和统计推断。按中国“药品临床试验管理规范”...     

在多中心临床试验中对中心校正后疗效的统计分析方法

在药物的临床试验中 ,其主要考核指标通常为疗效。疗效常分为四个等级 ,例如 :无效、进步、显效和痊愈。要比较两种处理疗效之间的差别 ,可用两样本的Ｗｉｌｃｏｘｏｎ秩和检验或Ｒｉｄｉｔ分析。此外 ,又常把无效和进步合并为无效 ,显效和痊愈合并为有效 ,计算并比较两种处理的有效率 ,这时可用 2× 2表的卡方检验。为了在较短时限内收集到足够多的病例数以及使所得结论的应用面更为广泛 ,药物的临床试验总采取多中心试验的方法 ,这是由某个单位的主要研究者总负责 ,多个单位的研究者合作 ,按同一个试验方案同时进行的临床试验〔1,2〕。由…     

多水平统计模型在多中心临床试验评价中的应用

在临床药物评价中常采用多中心临床试验〔1,2 ,3〕。同一药物在不同中心 (即医院 )间的试验结果往往表现出不完全一致 ,这不仅仅与药物本身有关 ,而且还可能与各中心的技术水平、医生素质等不完全一致有很大的关系。因此 ,在对多中心临床试验进行评价时 ,要考虑两种内部相关 :其一是个体 (病人 )在临床试验各阶段的重复测量值之间的内部相关 ;一个控制得好的临床试验 ,除药物特有的趋势效应外 ,某指标的重复测量值之间应有较高的相关。其二是各中心个体间的内部相关 ;理论上来讲 ,严格的临床试验是不允许有中心效应的 ,但由于各中心的医疗水…     

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.     

Logistic回归、CMH检验与Meta分析在多中心临床试验中应用探讨

目的探讨临床随机对照试验多中心效应比较的统计方法。方法以一项多中心临床随机对照试验数据为例,运用χ2检验、CMH检验、Meta分析及logistic回归分析。结果CMH检验显示各中心间效应值的一致性检验差异有统计学意义(P<0.05),扣除中心效应后,组间比较差异有统计学意义(P<0.05);Meta分析异质性检验差异无统计学意义(P>0.05),采用固定效应模型,合并后效应值组间差异有统计学意义(P<0.05),logistic回归分析,各中心效应值差异无统计学意义(P>0.05),组间效应差异有统计学意义(P<0.05),且存在可能影响效应的协变量。结论多中心临床随机对照试验研究中,如果存在分中心组间疗效差异趋势不一致时,可选择Meta分析及logistic回归分析,然后对三种分析方法的结果作出客观的评价。如果logistic回归分析存在影响效应的协变量,建议对这些协变量进行再分析。     

多中心临床试验（一）：组织与方案

所谓临床试验（ＣｌｉｎｉｃａｌＴｒｉａｌ）系指任何一种有病人参加的有计划的研究，这种研究的目的是寻求在相同的条件下，对未来病人的一种最合适的治疗方法。其基本特征是利用由有限病人样本（Ｓａｍｐｌｅ）得出的结果，对未来的具有相似条件的病人总体（Ｐｏｐｕｌ...     

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。     

多中心临床试验中受试对象的知情权应受到重视

大样本随机临床试验和Ⅲ期新药临床观察的受试对象都是人群.在试验前,虽然有前期的研究基础及严格的程序,但受试者仍处于某种程度的危险中,如新药的不良反应,某种治疗方法对患者生存率及重要临床事件的不利影响等.     

Barriers to clinical research participation in a diabetes randomized clinical trial

Little is known about how barriers to research participation are perceived, affected by or interact with patient characteristics, or how they vary over the course of a clinical trial. Participants (285) in the Renin–Angiotensin System Study (RASS), a randomized clinical primary prevention study of diabetic nephropathy and retinopathy at 2 Canadian and 1 US university, rated potential barriers to research participation yearly for 5 years. Baseline barriers rated as most adversely affecting participation were: missing work; frequency of appointments and procedures; study length; number of appointments and procedures; access to study location; and physical discomfort associated with procedures. Inadequate social support, unstable job, and the use of alcohol and drugs were cited relatively infrequently, suggesting that although they may be important, candidates for whom these might be issues likely self-selected out of the study. Gender and gender by age interactions were found for specific perceived barriers, such as work and child care, and baseline barriers correlated with adherence. Elucidating the natural history of barriers to research participation is a step toward identifying strategies for helping participants overcome them, and ultimately may enhance the conduct of research.     

整群随机设计在疫苗临床试验中的应用

当疫苗在人群中的覆盖率达到一定比例时,群体保护效果将保护未接种疫苗者。但传统疫苗临床评价采用的个体随机设计无法评估疫苗的群体保护效果。相较于个体随机设计,整群随机设计可以更全面地评估疫苗的总体保护效应。近年来,在疫苗临床的Ⅲ、Ⅳ期临床试验中,整群随机设计变得更加常见。但目前国内对整群随机设计在疫苗临床试验中的应用了解较少。因此,本文对整群随机设计在疫苗临床试验中的应用进行综述,为今后我国开展相关方面的研究提供参考。     

The rights of psychiatric patients in China: a survey of medical staff and consumers' attitudes toward patient participation in clinical trials

To explore and compare attitudes of consumers (patients and their family members) and medical staff toward clinical trials related to mental health in China, we developed two questionnaires for medical staff and patients and their family members. Approximately 66.2% of medical staff who had no research experience believed that patients could be persuaded to participate in clinical trials, but the percentage of consumers who believed so was just 12.5%. Both groups agreed that written informed consent was required; however, more medical staff than patients agreed that such consent could be provided by patients or their guardian (88.4% vs. 71.4%). Only 9.5% of medical staff thought that patient treatment would be compromised by refusal to participate; the proportion of consumers who thought the same was 29.4%. Great differences exist between medical staff and consumers' attitudes and beliefs regarding clinical trials. Medical staff were more likely to have a favorable attitude toward their patients participating in clinical trials and considered that informed consent could be provided by guardians rather than the patient.     

On choosing the number of interim analyses in clinical trials

Small but important therapeutic effects of new treatments can be most efficiently detected through the study of large randomized prospective series of patients. Such large scale clinical trials are nowadays commonplace. The alternative is years of polemic and debate surrounding several trials each too small to detect plausible differences with any certainty. Such trials produce equivocal and contradictory results, which could be predicted from power calculations based upon sensible pre-trial estimates of treatment differences. Unfortunately such calculations often lead to sample sizes of several thousands. It is not surprising that investigators tend to be over-optimistic in their estimation of treatment effects (which are necessarily uncertain) especially when the sample size requirements are so stark. In this paper a method is outlined for incorporating into the sample size calculations the uncertainty of the estimate made at the design stage of a clinical trial. In particular a formal scheme is described for deciding how many interim analyses should be performed to satisfy ethical and pragmatic requirements of large clinical trial design. Although the argument will be ‘Bayesian’, the criteria for assessment and comparison will be strictly of a Neyman-Pearson (i.e. significance testing) kind.     

基于人工智能干预的临床试验研究进展

随着越来越多的人工智能技术被开发应用于医疗卫生领域,近年来以人工智能为干预的临床试验开始不断出现.本文将介绍以人工智能为干预措施的临床试验的发展现状、方案指南、报告规范和面临的挑战与展望,以便于未来研究者规范地开展此类临床试验,推动人工智能技术在医疗卫生领域的发展与应用.     

Sample sizes for phase II and phase III clinical trials: an integrated approach

In this paper the following problem of clinical research is explored. Several potential new treatments are available for use against a certain disease. These are evaluated in a series of pilot studies which will constitute phase II clinical trials. The most promising will then be compared with a standard treatment in a phase III trial. Of interest will be the number of patients needed for the complete research programme, the proportions of these that should be involved in each phase, and the number of treatments which should be tried. Optimal strategies are found which maximize the probability that the overall programme identifies a treatment which is significantly better than the standard.     

Barriers and motivations for participation in preventive vaccine clinical trials: Experience of 5 clinical research sites

Recruitment in preventive vaccine trials (PVT) is challenging due to common barriers to clinical research and lack of vaccine confidence. Identifying determinants of participation can help to improve recruitment. A prospective survey was conducted in 5 French clinical investigational sites. People asked to participate in a PVT were given a questionnaire whether they decided to participate or not in the trial. A total of 341 people answered the survey: 210 accepting and 131 declining to participate in a PVT. Acceptors were significantly younger (38.5 vs 54.9 years old), more likely to be involved in early phase trials, had a higher level of education (p < 0.005) and a significantly better general opinion concerning vaccines (92.3% versus 72.3%, p < 0.005) compared with those who declined. Factors associated with acceptance or refusal were evaluated in 224 people in the 4 sites where both groups were included. In a multivariate analysis, three factors: older age, having heard about PVT through multiple sources and financial incentives were significantly associated with refusal to participate in the PVT. A generally favourable opinion of vaccines was associated with acceptance. The main motivation for participation was altruism (93.2%) whereas fear of side effects was at the forefront of the barriers (36.6%). Information given by the physician was a key point for decision-making in 70.2% of those who accepted. In brief, vaccine hesitancy may decrease recruitment in PVTs; reinforcing altruism and quality of information given are key points in acceptance of participation in PVT.     

Forging convictions: the effects of active participation in a clinical trial

This qualitative study explored non-specific influences on participation in, and outcomes of, a randomised controlled trial. It was nested within a single-blind clinical trial of western acupuncture which compared real acupuncture with two types of placebo control administered to National Health Service (NHS) patients awaiting hip and knee replacement surgery in England. Data collection (2004-2008) was based on narrative-style interviews and participant observation. The results indicate that trial recruitment and retention depend on a set of convictions forged largely as a result of contextual factors peripheral to the intervention, including the friendliness and helpfulness of research centre staff and status of the administering practitioner. These convictions also influence the reporting of the study outcomes, particularly if participants experience uncertainties when choosing an appropriate response. The findings suggest that participants in clinical trials are actively involved in shaping the research process, rather than passive recipients of treatment. Thus the outcomes of trials, notably those involving contact interventions, should be regarded not as matters of fact, but as products of complex environmental, social, interpretive and biological processes. In this paper, we develop and present a 'theory of active research participation' which offers a framework for understanding the impact of non-specific processes in clinical trials.