共查询到18条相似文献,搜索用时 171 毫秒
1.
《国际生殖健康/计划生育杂志》2020,(1)
数据协调委员会(Data Coordination Committee,DCC)是临床试验中一个独立第三方的数据管理机构,是提高临床试验数据质量,使数据结果更为准确、真实、可信的有效途径之一。文章以黑龙江中医药大学附属第一医院妇科临床基地一项大型不孕症临床研究为例,对数据协调委员会的建立、人员组成、在不孕症试验中的特色和优势及其具体职能进行描述;阐明了DCC在不孕症临床试验中的重要作用,能够最大程度地避免临床试验过程中的偏倚,增加试验透明度和可信度,提高临床试验管理效率。 相似文献
2.
3.
我国医院开展临床试验存在研究方案设计缺乏科学性,试验过程缺乏规范性,数据质量有待提高等问题。针对我国抗肿瘤药物临床试验现状,提出构建临床试验质量规范管理体系实践路径,包括在试验启动前多方参与共同修订研究方案确保其科学性;在试验过程中建立临床试验制度/SOP体系、质控体系、SAE报告管理体系;在试验后期建立数据质量管理体系、结果评估体系等。 相似文献
4.
文章就如何做好临床试验管理,实现对临床试验全程监管,主要从药物/器械临床试验机构对临床试验前准备阶段、试验阶段、试验结束阶段的监管情况,结合伦理委员会对临床试验的监管,重点阐述对临床试验监管的具体内容,并从实际工作经验出发对临床试验管理模式进行了探讨。 相似文献
5.
6.
7.
药物临床试验质量管理贯穿临床试验的全过程,应充分发挥研究者、机构办公室、申办方、伦理委员会等各方面的质控作用,确保临床试验遵循《药物临床试验质量管理规范》执行,有效保证临床试验过程的规范性和质量的可控性,切实保护受试者的安全和权益. 相似文献
8.
9.
正随着当代临床试验以及护士团队的不断进步与发展,临床研究护士(简称研究护士)作为一支新生力量应运而生。研究护士是指经主要研究者授权并通过相关培训后,在临床试验中协助研究者进行非医学性判断的事务性工作人员,在某种程度上可以独立参与到临床试验的协调管理和组织执行中。临床试验是 相似文献
10.
目的:通过实践案例探讨PDCA循环法与追踪方法学在药物临床试验机构管理工作中的作用。方法:介绍PDCA循环法与追踪方法学相结合的基本理论与方法,通过在药物临床试验中的具体实践,阐述其如何在机构管理过程中应用。结果:PDCA循环法与追踪方法学相结合进行临床试验的管理,能够提高机构对临床试验科学管理的效果。结论:在药物临床试验机构管理工作中,采用PDCA循环法与追踪方法学是可行的,这为机构高效管理临床试验提供了较好的方法。 相似文献
11.
李玉培乔建红温慧马帅 《中国卫生质量管理》2023,(3):060-63
目的 分析国内外护理质量临床试验特征,为我国护理质量临床试验管理提供参考。方法 在ClinicalTrials.gov平台检索建库至2021年10月10日结局变量为护理质量的临床试验,分析纳入护理质量临床试验的注册时间、注册数量、试验地点、注册单位、资金来源、研究疾病、研究类型、样本量、研究状态及结果报告等信息。结果 共获得142项护理质量临床试验。第一个护理质量临床试验注册于2001年,不同年份护理质量临床试验注册数量存在差异;试验地点以美洲和欧洲居多,注册单位以高等院校占比最高,资金来源分散;研究疾病分布广泛,主要包括肿瘤、糖尿病、精神分裂症、心肌梗死等;研究类型包括干预性研究和观察性研究,干预性研究占61.97%;样本量范围为8例~1 000 000例;85项试验处于已完成状态,仅11项试验报告结果。结论 护理质量临床试验基本特征不均衡,内容特征呈现多元化,研究状态及结果报告有待完善。建议我国相关机构提供护理质量临床试验注册指导,规范护理质量临床试验数据管理,建立护理质量临床试验评价机制。 相似文献
12.
董晶王雅琼朱娜周学锋 《中国卫生质量管理》2022,(9):072-75
试验用药品规范化管理有助于提升临床药物研究水平。从硬件设施、人员配备及资质、文件管理、质量控制等方面建设卫星药房,并采取GCP药房监管模式,实现试验用药品闭环管理。实施后,试验用药品质控问题减少,管理更加规范。卫星药房可作为GCP 药房的补充,确保试验用药品安全,提升临床试验质量。 相似文献
13.
Stopping rules and estimation problems in clinical trials 总被引:1,自引:0,他引:1
Stopping rules in clinical trials can lead to bias in point estimation of the magnitude of treatment difference. A simulation exercise, based on estimation of the risk ratio in a typical post-myocardial infarction trial, examines the nature of this exaggeration of treatment effect under various group sequential plans and also under continuous naive monitoring for statistical significance. For a fixed treatment effect the median bias in group sequential design is small, but it is greatest for effects that the trial has reasonable power to detect. Bias is evidently greater in trials that stop early and is dramatic under naive monitoring for significance. Group sequential plans lead to a multimodal sampling distribution of treatment effect, which poses problems for incorporating their estimates into meta-analyses. By simulating a population of trials with treatment effects modelled by an underlying distribution of true risk ratios, a Bayesian method is proposed for assessing the plausible range of true treatment effect for any trial based on interim results. This approach is particularly useful for producing shrinkage of the unexpectedly large and imprecise observed treatment effects that arise in clinical trials that stop early. Its implications for trial design are discussed. 相似文献
14.
朱丹丹夏慧琳王学军李岳飞张晓燕边立军 《中国卫生质量管理》2023,(2):081-84
目的 了解临床试验医疗器械使用安全现状,分析其影响因素,提出建议,为提高临床试验医疗器械管理水平提供参考。方法 收集内蒙古某三甲医院2018年1月1日-2021年12月31日上报的31项医疗器械临床试验项目中与患者安全相关的186份研究报告,对相关数据进行描述性分析。结果 不良事件报告占28.5%,严重不良事件报告占47.8%,器械缺陷报告占0.6%,方案偏离报告占23.1%;患者主要年龄段为>50岁~70岁(57.0%);心内科项目数量占比(51.6%)和报告数量占比(50.5%)均最大;患者安全事件与试验器械有关的报告有52份(28.0%);有合并症和并发症的患者有119人(63.9%)。结论 临床试验医疗器械使用安全与器械本身、研究者能力、方案执行程度、患者自身等因素有关。应加强临床试验项目质量管理医疗器械规范化管理、使用安全管理以及患者自身管理。 相似文献
15.
The sequential parallel clinical trial is a novel clinical trial design being used in psychiatric diseases that are known to have potentially high placebo response rates. The design consists of an initial parallel trial of placebo versus drug augmented by a second parallel trial of placebo versus drug in the placebo non-responders from the initial trial. Statistical research on the design has focused on hypothesis tests. However, an equally important output from any clinical trial is the estimate of treatment effect and variability around that estimate. In the sequential parallel trial, the most important treatment effect is the effect in the overall population. This effect can be estimated by considering only the first phase of the trial, but this ignores useful information from the second phase of the trial. We develop estimates of treatment effect that incorporate data from both phases of the trial. Our simulations and a real data example suggest that there can be substantial gains in precision by incorporating data from both phases. The potential gains appear to be greatest in moderate-sized trials, which would typically be the case in phase II trials. 相似文献
16.
Confronting publication bias: a cohort design for meta-analysis 总被引:8,自引:0,他引:8
R J Simes 《Statistics in medicine》1987,6(1):11-29
In evaluating therapies, clinical investigators often need to rely on the published clinical trial literature which may be biased in favour of studies with positive or 'encouraging' results and this may lead to erroneous conclusions of therapeutic effectiveness. The problem of publication bias can be magnified when the evaluation is based on a pooled analysis of clinical trial results, since in this case even small differences between treatment groups may reach statistical significance. In this paper a model is developed for pooling the results of clinical trials which is free from publication bias. It is proposed that an international registry of all clinical trials be established with the objectives and endpoints of each trial clearly defined in the register. In this way for each therapeutic issue researchers can select a cohort of clinical trials independently from the trial results. The approach is illustrated using the International Cancer Research Data Bank (ICRDB) registry of cancer clinical trials to evaluate the effect of chemotherapy on survival in advanced ovarian cancer. In this example, the conclusions based on a pooled analysis of registered trials have important differences from a more traditional review of the published trials. Implications of the results and problems in implementing the model are discussed. 相似文献
17.
Clinical trials can be considered health interventions as their primary aim is to impact on the health of a population. Given
that resources are scarce for both health care and health related research, trials could be designed such that they can be
demonstrated to be cost-effective, i.e., the costs of conducting the trial are justified given the forecasted long-term benefits.We
demonstrate how a model can be used to predict the cost-effectiveness of undertaking a clinical trial comparing alternative
regimens of colorectal cancer follow-up.The model forecasts costs and survival under two scenarios,with and without conducting
a clinical trial, with the outcome assessed in terms of years to payback for the clinical trial.The methodology shown can
be used both to provide information on appropriate trial design and/or in prioritizing between potential trials.
Douglas Coyle Clinical Epidemiology Unit, Ottawa Health Research Institute, 1053 Carling Avenue,Ottawa Hospital,Ottawa, Ontario K1Y 4E9,Canada,
e-mail: dcoyle@ohri.ca 相似文献