公众对临床试验的认知、实践与态度的调查研究

目的评价公众的临床试验的认知、实践与态度。方法采用匿名的横断面在线调查,共收集702份18岁以上中国公众的有效调查问卷。结果在702名被调查者中,有84.2%听说过临床试验,但是仅有6.0%作为受试者参与过药物临床试验。83.6%的被调查者知道“受试者的隐私和个人信息应该得到充分保护”,仅48.4%的被调查者知道“患者也可以参与设计和发起符合自己需要的临床试验”。41.7%的被调查者“愿意作为志愿者参加临床试验”。回归分析表明“工作/专业领域”“是否作为受试者参与过药物临床试验”“是否有亲人朋友作为受试者参与过药物临床试验”是影响公众参与临床试验意愿的显著因素。结论公众对临床试验的认知程度尚可,但是对于以患者为中心的临床试验发展趋势认识较低。公众的临床试验参与意愿较低,并且受自身专业背景以及相关经历影响很大。有必要开展针对公众的临床试验科普活动,积极发展临床试验公益团体,提升公众临床试验认知水平和参与积极度。     

Patient-Centeredness in the Design of Clinical Trials

Evidence from clinical trials should contribute to informed decision making and a learning health care system. People frequently, however, find participating in clinical trials meaningless or disempowering. Moreover, people often do not incorporate trial results directly into their decision making. The lack of patient centeredness in clinical trials may be partially addressed through trial design. For example, Bayesian adaptive trials designed to adjust in a prespecified manner to changes in clinical practice could motivate people and their health care providers to view clinical trials as more applicable to real-world clinical decisions. The way in which clinical trials are designed can transform the evidence generation process to be more patient centered, providing people with an incentive to participate or continue participating in clinical trials. To achieve the transformation to patient-centeredness in clinical trial decisions, however, there is a need for transparent and reliable methods and education of trial investigators and site personnel.     

北京医药产品临床试验现状分析及对策

随着药品临床实验管理国际统一标准的逐步形成,我国逐步建立了药品监督管理体系和临床实验机构,开始进行规范的药品临床实验。本文对北京的临床药理基地进行了系统调研,找出阻碍临床试验发展的问题,并提出促进北京医药产品临床试验发展的对策与措施。     

The industrialization of clinical research

Recent controversies over the protection of human subjects, payment of physicians for recruiting patients to clinical trials, Food and Drug Administration (FDA) removal of approved drugs from the market, and reporting of results of clinical trials have highlighted important facets of clinical research. Less visible has been the industrialization of clinical research, and especially of clinical trials, that is, its emergence as a "line of business" of substantial magnitude and rapid growth. The growth of drug-industry outsourcing of clinical trials and the concomitant rise of a contract research industry are described in this paper, which argues for greater transparency in the conduct of both publicly and privately sponsored clinical trials.     

Clinical trials in Canada: whose interests are paramount?

More than 80 percent of clinical drug trials in Canada are funded by the pharmaceutical industry. This article evaluates the overall state of clinical trials in Canada and looks at the interplay between public and private interests. Health Canada has adopted standards developed by the International Conference on Harmonization, a body that is heavily influenced by industry. Commercial interests are increasingly involved in recruiting patients into clinical trials and in running these trials. It is in industry's interests to conduct drug tests on people for which it is easiest to see benefits. These interests are not fundamentally challenged by Health Canada's policy of issuing nonmandatory guidelines on who should and should not be included in clinical trials. The outcome of clinical trials is heavily influenced by commercial sponsorship, with the result that trials may favor corporate interests rather than the interests of the public. How Health Canada deals with that possibility is not known, because of its strict policy of treating clinical trial data as private property. If clinical trials are to serve the purpose for which they are designed, developing reliable and objective information about new drugs, then commercial interests cannot be allowed to take precedence over health interests.     

基于ClinicalTrials.gov的护理质量临床试验特征分析

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。     

The impact of health insurance mandates on drug innovation: evidence from the United States

An important health policy issue is the low rate of patient enrollment into clinical trials, which may slow down the process of clinical trials and discourage their supply, leading to delays in innovative life-saving drug treatments reaching the general population. In the US, patients’ cost of participating in a clinical trial is considered to be a major barrier to patient enrollment. In order to reduce this barrier, some states in the US have implemented policies requiring health insurers to cover routine care costs for patients enrolled in clinical trials. This paper evaluates empirically how effective these policies were in increasing the supply of clinical trials and speeding up their completion, using data on cancer clinical trials initiated in the US between 2001 and 2007. Our analysis indicates that the policies did not lead to an increased supply in the number of clinical trials conducted in mandate states compared to non-mandate states. However, we find some evidence that once clinical trials are initiated, they are more likely to finish their patient recruitment in a timely manner in mandate states than in non-mandate states. As a result, the overall length to completion was significantly shorter in mandate states than in non-mandate states for cancer clinical trials in certain phases. The findings hint at the possibility that these policies might encourage drug innovation in the long run.     

药物临床试验质量管理案例分析及建议

药物临床试验中,受试者损害事件不可避免。对药物临床试验中受试者损害案例进行分析,从药物临床试验立项与执行和损害事件后的发生与处理两方面,针对药物临床试验赔偿管理提出若干建议。     

常州市第一人民医院药物临床试验工作的实践体会

从对开展药物临床试验的意义以及江苏省常州市第一人民医院在药物临床试验机构工作中关于制定管理制度、强化人员培训、加强监督管理等方面的实践总结,希望对我国的药物临床试验工作提供些许有益的思考.     

The state of the clinical trials system today

This article describes the components, process, and regulatory requirements of the clinical trials system as well as the changes that have resulted from increased attention to patient safety. Also discussed are the economic and scientific pressures on pharmaceutical and medical device companies to run efficient clinical trials with rapid enrollment of subjects. The complexity of the clinical trials system and the demand for efficient trials that protect patients has led to the need for special training of physicians who conduct clinical trials. This year the first board examination for certified physician investigators will be offered through the Physician Investigator Certification Program of the American Academy of Pharmaceutical Physicians.     

Regulatory oversight of clinical trials in Africa: Progress over the past 5 years

Randomized controlled clinical trials represent the best way to establish the therapeutic or preventive value of medicines. This decade has seen a strong shift in the location of clinical trials from industrialized countries to developing countries, including many in Africa. However, without independent strong regulatory and ethical oversight of clinical trials the safety of research subjects, and scientific integrity of clinical data cannot be verified. This article draws up a portrait of clinical trials regulation in Africa in support of development of priority medicines, highlights challenges and presents the progress made by countries under WHO guidance over the past 5 years.     

Increasing Primary Care Physician Support for and Promotion of Cancer Clinical Trials

Only 2.5%–3% of adult cancer patients participate in cancer clinical trials, yet about 20% of cancer patients are medically eligible to participate. Research suggests that the primary care provider (PCP) can influence a patient''s awareness of, and potentially, his or her decision to consider a clinical trial. To address low cancer clinical trial accrual rates, ‘Imi Hale Native Hawaiian Cancer Network partnered with The Queen''s Cancer Center to provide and evaluate education on clinical trials to Hawai‘i PCPs. The educational materials were developed from a national curriculum and tailored to local audiences. Objectives of the curriculum were to educate PCPs about common myths (attitudinal barriers) around clinical trials and suggest ways that PCPs can introduce the concept of clinical trials to their patients with cancer or suspicion of cancer. The curriculum was tested on 128 PCPs in 2012. Knowledge of the PCP''s role and their willingness to mention clinical trials were measured through a post-test immediately following the presentation, which 74 (58%) PCPs completed. The post-test results suggested an increase in awareness among PCPs of their potential role in cancer clinical trial accrual, and an increase in PCP willingness to mention clinical trials to their patients with suspicion of cancer or diagnosed with cancer. Although findings suggest that this intervention is useful in increasing PCP receptivity to promoting cancer clinical trials, more research is needed to test if increased willingness results in increased accrual of cancer patients into clinical trials in Hawai‘i.     

论药物临床试验受试者的权益保护

药物临床试验在国内日渐频繁,但受试者权益保护却没有得到应有的重视。介绍了受试者在药物临床试验中享有的生命健康权、知情同意权、隐私权、医疗救治及补偿权,以及应落实的相关保障措施等,并分析了受试者权益保护中的种种不足。     

二类医疗器械临床试验基本要点

针对医疗器械产品注册审评过程中临床试验的常见问题,对二类医疗器械临床试验的基本要点作一简单的阐述,指导研发企业正确地进行临床试验。     

A Hungarian example for handsearching specialized national healthcare journals of small countries for controlled trials. Is it worth the trouble?

The objective of this study was to determine whether a Hungarian language journal of clinical neuroscience, which is not indexed in MEDLINE, contains any reports of randomized or quasi-randomized clinical trials that are not also reported in MEDLINE-indexed publications. A cover-to-cover handsearch was performed of the journal Clinical Neuroscience/Ideggyógyászati Szemle, the official journal of Hungarian societies of neurology, neurosurgery, psychiatry and related clinical neurosciences, from its first volume in 1950 to the end of 1998; and a search of MEDLINE for other reports of the trials identified. Clinical trials in which patients were allocated to interventions by randomized, quasi-randomized or possibly randomized means were identified. Controlled trials were tabulated and coded as randomized controlled trials or controlled clinical trials according to the definitions of the Handsearch Manual of the Cochrane Collaboration. We identified three randomized and eight quasi-randomized trials. Six of the 11 trials were not reported in MEDLINE indexed publications. In conclusion, to obtain a comprehensive controlled trials register, specialized healthcare journals printed in small numbers in the national languages of small countries should be searched.     

Training Community Health Workers About Cancer Clinical Trials

Innovative projects to reduce disparities in cancer treatment and research include partnerships between academic and community cancer centers, patient navigation programs and strategies to promote community awareness, education and engagement. A 4 h training program about cancer clinical trials was developed through a needs assessment and in collaboration with community health workers who served as consultants and a larger advisory board comprised of community health workers, educators and clinical trialists. This program was delivered first as a collaboration between a phsycian who is experienced in the conduct of clinical research and two community health workers, and subsequently by the community health workers alone. We report on four workshops attended by a total of 61 community health workers recruited from Boston-area hospitals, community health centers and outreach programs. Support for and knowledge of clinical trials was measured in a pretest and post-test, which also included a satisfaction rating. Participants had a range of prior experience with clinical trials in the context of their personal and professional experience. Mean accuracy of knowledge about clinical trials increased from 72 to 84%, support for clinical trials improved considerably, and satisfaction with the training experience was high. Knowledge gaps and low levels of support for cancer clinical trials among community health workers can be improved with a short training program delivered by other community health workers. Further research is needed to identify the impact of this training on accrual to cancer clinical trials.     

Longitudinal data analysis (repeated measures) in clinical trials.

Longitudinal data is often collected in clinical trials to examine the effect of treatment on the disease process over time. This paper reviews and summarizes much of the methodological research on longitudinal data analysis from the perspective of clinical trials. We discuss methodology for analysing Gaussian and discrete longitudinal data and show how these methods can be applied to clinical trials data. We illustrate these methods with five examples of clinical trials with longitudinal outcomes. We also discuss issues of particular concern in clinical trials including sequential monitoring and adjustments for missing data. A review of current software for analysing longitudinal data is also provided. Published in 1999 by John Wiley & Sons, Ltd. This article is a US Government work and is the public domain in the United States.     

Symplicity^TM器械特征及临床研究进展

去肾神经术治疗高血压已经被多项临床实验证实了其安全性和有效性,SymplicityTM是第一个进行临床试验,并通过欧盟CE认证进行临床治疗的射频导管消融肾去交感化治疗系统,它包括单极和多极消融导管系列。近期关于SymplicityTM导管相关的临床试验证实,消融后血压可明显降低,且并发症发生率维持在较低水平。更多的临床试验正在进行中,本文就SymplicityTM的特征及临床研究进展作一阐述。     

Historical and methodological developments in clinical trials at the National Cancer Institute

The first randomized clinical trial at the National Cancer Institute (NCI), planned in 1954, commenced in 1955 for the treatment of patients with acute leukaemia. The programme in clinical trials at NCI had strong influence from the clinician and administrator, C. Gordon Zubrod, who introduced the randomized clinical trial at NCI and organized the co-operative clinical trials programme of the Cancer Chemotherapy National Service Center (CCNSC) beginning about 1955. The biostatistician, Marvin Schneiderman, collaborated on the first randomized trials in acute leukaemia and solid tumours and recruited the biostatisticians and statistical centres in the early phase of the co-operative clinical trials programme of the CCNSC. From the beginning, there was acceptance of the principles of the randomization of patients and the statistical analysis of data. The sequence of clinical trials for a new agent included the non-randomized phase I (dosage finding) and phase II (preliminary efficacy) trials as well as the phase III (comparison of treatments) trials. New concepts for the treatment of patients developed from 1955 to the mid-1960s included the combination of therapies with independent activity to increase response rates and the administration of therapy to patients in a disease-free (remission) state to prolong the disease-free state. Methodological developments related to clinical trials up to the mid-1960s included: a plan for phase II trials (Gehan); a generalization of the Wilcoxon test for the comparison of survival distributions with right-censored data (Gehan); a test of proportional hazards for survival distributions, which later became known as the Mantel-Haenszel test (Mantel), and an exponential regression model with an explanatory variable (Feigl and Zelen).     

肿瘤专科医院药物临床试验质量规范管理体系研究

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。