肿瘤专科医院I期临床研究病房的建设与实践

目的 总结湖南省肿瘤医院构建肿瘤专科特色I期临床研究病房的实践经验,为正在建设I期临床研究病房的医疗机构提供参考和借鉴。方法 我院I期临床研究病房以肿瘤受试者为中心,以多学科团队协作模式进行肿瘤受试者的全病程管理,建立高效的管理体系来保障I期临床研究病房的建设,主要内容包括病区管理、受试者管理、研究团队管理、质量控制、信息化建设等。结果 I期临床研究病房成立以来,病房在研项目160余项,I期病房方案违背率低于1%,采血及处理生物样本超窗发生率均低于0.8%,受试者护理不良事件发生率低于0.45%,第三方测评满意度均高于96%,肿瘤受试者和家属满意度增高。结论 我院基于肿瘤专科特色建设高效的I期临床研究病房管理体系,搭建了湖南省临床试验培训、科研、信息交流平台,其服务模式和管理体系可推广至其他医院,进一步推动临床研究在全国范围的发展。     

Safety assessment of the commensal strain Bacteroides xylanisolvens DSM 23964

We recently isolated and characterized the new strain Bacteroides xylanisolvens DSM 23964 and presented it as potential candidate for the first natural probiotic strain of the genus Bacteroides. In order to evaluate the safety of this strain for use in food, the following standard toxicity assays were conducted with this strain in both viable and pasteurized form: in vitro bacterial reverse mutation assay, in vitro chromosomal aberration assay, and 90day subchronic repeated oral toxicity studies in mice. No mutagenic, clastogenic, or toxic effects were detected even at extremely high doses. In addition, no clinical, hematological, ophthalmological, or histopathological abnormality could be observed after necropsy at any of the doses tested. Hence, the NOAEL could be estimated to be greater than 2.3×10(11) CFUs, and 2.3×10(14) for pasteurized bacteria calculated as equivalent for an average 70kg human being. In addition, the absence of any in vivo pathogenic properties of viable B. xylanisolvens DSM 23964 cells was confirmed by means of an intraperitoneal abscess formation model in mice which also demonstrated that the bacteria are easily eradicated by the host's immune system. The obtained results support the assumed safety of B. xylanisolvens DSM 23964 for use in food.     

GCP与临床试验质量管理

通过研究天津市传染病医院在药物临床试验工作中具体实施《药物临床试验质量管理规范》（Good Clinical Practice, GCP）的实际情况,探讨如何提高临床试验质量的具体措施。药品的安全、有效关乎人民的生命健康,因此药物临床试验的科学性与真实性绝对不容质疑。做好药物临床试验工作必须保证试验质量,医院必须高度重视药物临床试验机构的发展,紧紧把握工作重点,按照GCP及相关法律法规要求开展工作,建立完善且行之有效的管理体制,规范试验流程,加强对医护人员的GCP培训及科研队伍建设,不断增强管理意识、提高药物临床试验质量。     

Good Clinical Practice and Audits for Dual X-ray Absorptiometry and X-ray Imaging Laboratories and Quality Assurance Centers Involved in Clinical Drug Trials, Private Practice, and Research

Good Clinical Practice (GCP) guidelines, with an emphasis on quality and validation of processes and data, must be applied to the use of imaging in clinical drug development. All participants, including the sponsor, principal investigator, site staff, quality assurance centers, and contract research organizations, must be cognizant of the need for application of these principles to their activities related to the imaging programs. This article discusses the various aspects of GCP as they need to be applied to the use of dual X-ray absorptiometry (DXA) for bone densitometry and X-rays for vertebral fracture assessment in clinical trials for osteoporosis, as well as research and private practice settings. The theory of proper audit conduct to verify clinical trial data is presented.     

More evidence on proneurocognitive effects of add-on mirtazapine in schizophrenia

Enhancement of neurocognition is essential in the treatment of schizophrenia. In our previously reported six-week Randomized Controlled Trial (RCT) mirtazapine added to conventional antipsychotics improved not only negative, but also positive symptoms and neurocognition in difficult-to-treat schizophrenia. The present study aimed to explore whether a prolonged exposure to mirtazapine could further improve neurocognition.Completers of the RCT who were able and willing to proceed to the extension phase received open label mirtazapine for an additional 6 weeks. During the extension phase, both groups (i.e., patients who previously received mirtazapine and those who received placebo) and the whole population showed improvement on a number of neurocognitive tests. Patients who shifted to open label mirtazapine from placebo achieved in the six following weeks similar results as their initially mirtazapine-treated counterparts did during their first 6 weeks of mirtazapine exposure. Middle-term mirtazapine treatment (12 weeks) demonstrated an advantage over short-term mirtazapine treatment (6 weeks) on Stroop Dots time and Trail Making Test, part B, number of mistakes (t = − 2.562, p = 0.035 and t = − 2.42, p = 0.043, correspondingly).Mirtazapine added to antipsychotics consistently shows desirable effects on neurocognition. Lengthy treatment seems worthwhile. Mirtazapine may become a safe and cost-saving neurocognitive enhancer in schizophrenia, yet more studies are needed.     

综合性医院临床试验药物中心化管理模式的建立

目的：探讨综合性医院的临床试验药物中心化的管理模式。方法：结合本院实际情况,从标准操作规程的制定、硬件设施建设、人员培训,以及信息化系统的应用等方面,介绍试验药物中心化管理方法。结果：此种管理具有明显优势,充分发挥了药师专业特长,专人专职集中管理,有效地提高了试验药物管理质量。结论：各医院需要结合自身条件,改进和完善试验药物中心化管理方法,提高信息化管理水平,这对于构建规范化、精细化的试验药物中心化管理模式具有重要意义。     

医疗机构开展疫苗早期临床试验的法规要求及关注点探究

目的:汇总分析疫苗早期临床试验的法规要求及临床试验过程中的关注点,为开展疫苗早期临床试验的医疗机构、相关管理和研究人员提供参考.方法:收集我国现行法规、规范性文件和技术指南,梳理法规中对疫苗早期临床试验的合规要求.结果 与结论:结合医疗机构实际特点,对疫苗早期临床试验中的场地及设施设备、质量管理体系、人员配备、疫苗管理...     

国内外药物临床试验GCP检查概述与启示

本文概述了美国、欧盟、日本和中国的GCP检查要求,对GCP检查中涉及的组织机构、检查员数量及能力、检查与稽查类型、检查对象、检查过程、检查评价、处罚措施等方面进行分析和比较,为我国GCP检查制度的改革提供参考。