<p>With increasing incidence and mortality, cancer is the leading cause of death in China and is a major public health problem. Because of China's massive population (1.37 billion), previous national incidence and mortality estimates have been limited to small samples of the population using data from the 1990s or based on a specific year. With high-quality data from an additional number of population-based registries now available through the National Central Cancer Registry of China, the authors analyzed data from 72 local, population-based cancer registries (2009-2011), representing 6.5% of the population, to estimate the number of new cases and cancer deaths for 2015. Data from 22 registries were used for trend analyses (2000-2011). The results indicated that an estimated 4292,000 new cancer cases and 2814,000 cancer deaths would occur in China in 2015, with lung cancer being the most common incident cancer and the leading cause of cancer death. Stomach, esophageal, and liver cancers were also commonly diagnosed and were identified as leading causes of cancer death. Residents of rural areas had significantly higher age-standardized (Segi population) incidence and mortality rates for all cancers combined than urban residents (213.6 per 100,000 vs 191.5 per 100,000 for incidence; 149.0 per 100,000 vs 109.5 per 100,000 for mortality, respectively). For all cancers combined, the incidence rates were stable during 2000 through 2011 for males (+0.2% per year; P = .1), whereas they increased significantly (+2.2% per year; P CA Cancer J Clin 2016;66:115 132. 2016 American Cancer Society.</b></p>

目的：讨论“6S 管理”在药品管理中的应用，以规范病区药品管理，提高患者用药安全管理水平。方法将“6S”理论及管理模式应用在药品管理中，即从整理、整顿、清扫、规 范、素养、安全六个项目，实行全员参与和专人负责制，完善药品管理制度，定期检查，不断改进。结果病区药品管理质量明显提高。药品储存与养护方面得分率由 19%增加到98%，效期药品管理得分率由20%提高至100%。药品定位摆放、账物相符、无1例过期、失效药品。结论6S 管理可更有效地保证患者的用药安全，提升护理质量，是病区用药质量控制的有效方法。

The development of targeted therapies has changed the approach to early oncological clinical trial design. Identification of patient populations most likely to derive benefit and the biologically effective dose are now as important as determination of the maximum tolerated dose. Completion of the ‘pharmacological audit trail’ highlights drugs most likely to progress through to license, so resources can be allocated appropriately. Key to the success of this changing model is the validation/qualification of circulating biomarkers. These might provide a readily accessible and dynamic picture of drug effect, tumor response and toxicity with minimum risk to patients. This review article examines circulating biomarkers currently used in early oncological clinical trials. It considers the evidence for their employment, limitations and challenges for future development.

临床研究协调员是药物临床试验中的重要组成部分，在试验的管理和协调中具有举足轻重的作用。该文拟通过介绍临床研究协调员的职责，并探讨现有的管理模式及其利弊，从而阐明临床研究协调员在临床试验质量保证体系中的作用，为提高临床试验质量提供借鉴。

药物临床试验是在相关法规规范下的具有严谨性和科学性的临床研究工作，其研究资料及结果是药品监督管理部门进行新药审批的重要内容和关键依据。良好的质量控制是提高药物临床试验质量的必要条件之一。我科于2008年10月作为我院药物临床试验外科学骨科专业，开始承接相关临床药物试验研究，并重点在质量控制方面进行了有益探索。

PDCA循环管理是一套广泛应用于质量管理的标准化、科学化循环体系。探索PDCA循环理论应用于药物临床试验质量管理体系，加强对临床试验过程中各环节的控制，强化质量检查反馈控制，明确各级质控人员的职责，注重培训体系建设。 PDCA管理体系在临床试验质量管理中发挥重要作用，全面提高了临床试验质量。

Abstract Background This is an updated version of a Cochrane review published in Issue 11, 2013 in the Cochrane Library. In many clinical areas, integrated care pathways are utilised as structured multidisciplinary care plans that detail essential steps in caring for patients with specific clinical problems. In particular, care pathways for the dying have been developed as a model to improve care of patients who are in the last days of life. The care pathways were designed with an aim of ensuring that the most appropriate management occurs at the most appropriate time, and that it is provided by the most appropriate health professional. Since the last update, there have been sustained concerns about the safety of implementing end-of-life care pathways, particularly in the United Kingdom (UK). Therefore, there is a significant need for clinicians and policy makers to be informed about the effects of end-of-life care pathways via a systematic review. Objectives To assess the effects of end-of-life care pathways, compared with usual care (no pathway) or with care guided by another end-of-life care pathway across all healthcare settings (e.g. hospitals, residential aged care facilities, community). In particular, we aimed to assess the effects on symptom severity and quality of life of people who are dying, or those related to the care, such as families, carers and health professionals, or a combination of these. Search methods We searched the Cochrane Central Register of Controlled Trials (CENTRAL; Cochrane Library; 2015, Issue 6), MEDLINE, EMBASE, PsycINFO, CINAHL, review articles, trial registries and reference lists of relevant articles. We conducted the original search in September 2009, and the second updated search in July 2015. Selection criteria All randomised controlled trials (RCTs), quasi-randomised trials or high quality controlled before-and-after studies comparing use versus non-use of an end-of-life care pathway in caring for the dying. Data collection and analysis Two review authors independently assessed the results of the searches against the predetermined criteria for inclusion, assessed risk of bias, and extracted data. We used standard methodological procedures expected by Cochrane. Main results We screened 3028 titles, and included one Italian cluster RCT with 16 general medicine wards (inpatient units in hospitals) and 232 carers of cancer patients in this updated review. We judged the study to be at a high risk of bias overall, mainly due to a lack of blinding and rates of attrition. Only 34% of the participants (range 14% to 75% on individual wards) were cared for in accordance with the care pathway as planned. However, these issues were to be expected due to the nature of the intervention and condition. The study population was all cancer patients in their last days of life. Participants were allocated to care using the Liverpool Care Pathway (LCP-I, Italian version of a continuous quality improvement programme of end-of-life care) or to standard care. The primary outcomes of this review were physical symptom severity, psychological symptom severity, quality of life, and any adverse effects. Physical symptom severity was assessed as overall control of pain, breathlessness, and nausea and vomiting. There was very low quality evidence of a difference in overall control of breathlessness that favoured the Liverpool Care Pathway group compared to usual care: the study reported an odds ratio (OR) of 2.0 with 95% confidence intervals (CIs) 1.1 to 3.8. Very low quality evidence of no difference was found for pain (OR 1.3, 95% CI 0.7 to 2.6, P = 0.461) and nausea and vomiting (OR 1.5, 95% CI 0.7 to 3.2, P = 0.252). None of the other primary outcomes were assessed by the study. Limited data on advance care planning were collected by the study authors, making results for this secondary outcome unreliable. None of our other secondary outcomes were assessed by the study. Authors' conclusions There is limited available evidence concerning the clinical, physical, psychological or emotional effectiveness of end-of-life care pathways.

在对涉及人体的临床试验进行伦理审查时,对受试者的保护是审查的主要目的和关注重点.本研究论述了审查过程中如何权衡受试者的权益、安全、健康与科学和社会利益之间的关系、如何审查知情同意书中的“伤害赔偿”条款以及与保险相关的条款、科学界定涉及弱势群体的人体生物医学试验项目、涉及弱势群体的试验项目如何进行伦理审查等目前比较敏感的问题.