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药物临床试验机构应用信息技术手段对临床试验实施过程进行监管,可以保证试验操作的规范化,提高临床试验质量管理效率。本文介绍了本机构研发临床试验全流程信息化管理系统的情况,并就系统构建的合规化和应用的安全性进行探讨。 相似文献
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《中国药房》2015,(4):445-447
目的:利用计算机网络技术,实现医疗机构药物临床试验信息化管理。方法:在医院信息系统基础上研发药物临床试验专用操作模块,实施信息化的操作模式并评价其效果。结果与结论:在医院信息系统中成功嵌入免费医嘱管理、试验药物管理和机构监管模块,研究者可以在系统中进行免费检查检验、开处方以及免费药物发放的操作,机构可以通过系统实现对临床试验的过程监控。使用该管理模式后,加快了试验的开展,住院受试者的血常规报告反馈时间由1d缩短至1h,核磁共振报告反馈时间由2d缩短至1d。该模式极大地方便了机构对各临床试验项目进行药物管理、过程监管、数据溯源和数据统计等工作,提高了临床试验的安全性和数据的准确性,使临床试验质量管理更科学。 相似文献
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目的: 选取药物临床试验市场广阔的印度及药物临床试验监管历史悠久的澳大利亚,就临床试验实施现状与监管方式两方面与我国进行对比,为我国临床试验的科学监管提供对策。方法:采取文献研究法、比较分析法等理论分析方法,从国内外的法律法规、试验流程、试验对象等角度分析探讨,对比国内外临床试验监管的异同。结果:临床试验是对药物的有效性、安全性进行科学评估的过程,是药物研发过程中的重要环节。随着我国医药行业的蓬勃发展,药物临床试验数量大幅增加,但临床试验管理中暴露的诸多问题也不容小觑。我国临床试验监管尚存在不足,临床试验优势资源紧缺,临床试验管理体系仍不完善。结论:我国应当有效借鉴国外经验、汲取教训,制定更为完善的监管措施与规范制度, 保障药物临床试验的质量,优化我国药物临床试验的监管水平。 相似文献
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目的:依托先进的临床研究管理理念,采用信息化技术手段,改变我国西北地区临床试验机构条件与水平相对落后的局面,探索解决我国临床试验发展不均衡的问题。方法:结合西安交通大学第一附属医院临床试验机构日常工作需求和管理经验,开发建立符合新时期监管要求的临床试验机构管理信息化平台(clinical trial institution management system, CTIMS),并为西北地区临床试验机构的临床研究能力和管理水平的提升提供解决方案。结果:西北地区临床试验机构通过临床试验机构信息化平台,可获得规范化、数字化、智能化的临床试验管理方式,使其进入临床研究的“快车道”,达到缩小与沿海发达地区临床研究机构能力差距的目的。结论:通过临床试验机构管理系统的应用,提升西北地区临床试验机构临床研究能力和管理效率及水平,改善西北地区临床试验发展相对落后的局面。 相似文献
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目的:探讨临床试验信息化管理体系建设及其在中医药临床试验过程管理中的实践,提高药物临床试验的管理效率。方法:与天津贝肯医疗科技有限公司合作,在成都中医药大学附属医院构建临床试验机构信息化管理平台,通过内网系统与医院原有的医院信息管理系统(HIS)、临床实验室检验系统(LIS)、放射信息管理系统(RIS)等闭合系统对接,经过加密传输后,与运行于互联网的信息系统完成数据交换和对接,将临床试验用户管理、项目管理、受试者信息管理、过程信息管理、试验药物管理等实现电子信息化,并对数据的安全、稳定和效率进行过程分析。结果:该系统在临床试验管理过程中实现了数据的安全、稳定和畅通,极大地提高了中医药临床试验项目管理效率。结论:引入临床试验研究信息化管理系统并与院内HIS,LIS整合是实现中医药临床试验机构现代化管理的必由之路,是践行中医药守正创新的重要途径之一。 相似文献
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《中国药房》2015,(1):18-20
目的:探讨药物临床试验培训的方法和模式,提高药物临床试验水平及质量。方法:总结药物临床试验相关法规对药物临床试验培训的要求,以我院为例分析药物临床试验培训模式存在的问题并提出对策。结果与结论:药物临床试验相关法规明确规定了药物临床试验相关人员要经过药物临床试验技术与法规的培训,药物临床试验机构要建立人员培训制度。针对临床试验相关人员对临床试验的认知水平较低、现有资格认定的培训内容与临床试验工作需求有落差、研究者对临床试验进行过程中的培训不够重视等问题,建议采取加强管理和监督、结合临床试验需求组织培训、加强监查员管理等措施;同时建议有关部门加强监督和管理,结合药物临床试验工作需求进行培训,以确保药物临床试验培训效果,从而提升临床试验水平。 相似文献
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自2015年启动药品医疗器械审评审批制度改革以来,我国药品监管领域发生了翻天地覆的变化,药物临床试验的监管也不例外。我国对药物临床试验的监管由药物临床试验开展前的药物临床试验质量管理规范认证逐渐转变为更为科学的事前(临床试验机构的备案)-事中(临床试验过程的风险管控)-事后(临床试验现场核查)全过程的监管。随着国务院及国家药品监督管理部门近几年来对药品注册监管体制机制改革的持续深入,一系列相关文件或配套制度发布并落地实施,我国也立足具体实际,借鉴国际先进经验,初步建立了基于风险启动临床试验现场核查的工作程序。本文对该程序进行介绍与讨论,以便注册申请人、临床试验机构以及合同研究组织更好地理解,并就围绕目前存在的问题与挑战进行探讨与展望。 相似文献
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LGC is the UK's designated National Measurement Institute for chemical and bioanalytical measurement, and through this role improves the quality and international acceptance of measurements performed within the UK. This research spotlight, highlighting measurement 'across the scale', from elemental analysis and small molecules, through to proteins, DNA and RNA and on to whole cells and tissues, demonstrates how LGC is supporting the clinical sector by ensuring sound measurement practice that underpins clinical efficacy, quality assurance and patient safety. 相似文献
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Norfloxacin, a nalidixic acid analog, is the first of the fluorinated quinolinecarboxylic acids to be marketed in the United States. It demonstrates potent antibacterial activity against aerobic, gram-negative bacteria including the Enterobacteriaceae, gentamicin-resistant Pseudomonas aeruginosa, and penicillin-resistant Neisseria gonorrhoeae. Norfloxacin exhibits good activity against methicillin-resistant and -sensitive Staphylococcus aureus, but less activity against most other aerobic, gram-positive organisms. Anaerobic bacteria are resistant to the drug. Resistance to norfloxacin is not plasmid mediated, but is secondary to bacterial mutation, and occurs less frequently than nalidixic acid resistance. Its pharmacokinetic properties after a 400-mg oral dose consist of a peak serum concentration of 1.3-1.58 micrograms/ml, an elimination half-life of 3-7 hours, and good penetration into kidney and prostatic tissues. Renal excretion is the major route of elimination. Norfloxacin is highly effective in the treatment of uncomplicated and complicated urinary tract infections, and gonococcal urethritis. Adverse effects are generally well tolerated and usually do not require discontinuation of therapy. 相似文献
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One of the ironies in the use of power in today's management setting is that the manager of workers at a high level of readiness is actually giving more power to subordinates as a leadership strategy. Indeed, the empowered manager may achieve goals by shifting responsibility from the manager to the employee, providing a vision for subordinates, providing resources when possible, and providing the freedom to accomplish organizational goals. The challenge for the manager is to determine employee level of readiness and to assess that readiness for different assignments and varying responsibilities. Given the proper situation, the manager may paradoxically gain power (influence over others) by giving others a high degree of responsibility for their actions. 相似文献
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目的探讨小儿支原体肺炎的临床发病特点及治疗措施。方法选取商丘市第一人民医院2012年10月至2013年5月收治的164例小儿支原体肺炎患儿,根据用药的不同分为观察组(86例)和对照组(78例)。观察组应用阿奇霉素治疗,对照组应用红霉素治疗,观察两组的疗效及症状、体征改善情况。结果观察组患儿总有效率为96.51%,明显高于对照组的83.33%,两组比较差异有统计学意义(P〈0.05);观察组患儿症状、体征改善时间,肺部哕音消失时间及平均治疗时间较对照组明显缩短,差异有统计学意义(P〈0.05)。结论小儿支原体肺炎肺外表现多样,阿奇霉素序贯疗法是安全且有效的,能较好地改善病情,提高治愈率。 相似文献
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Pharmacokinetic and pharmacodynamic principles should be regarded in the assessment and proper management of patients exposed to a poison. Clinicians must apply these principles to make rational clinical decisions regarding the significance of the poisoning (risk assessment) and to formulate an appropriate management plan. However, pharmacokinetic processes and parameters may be changed in the patient with acute poisoning. This may result from saturation of the capacity of a number of physiological processes due to the high dose, or the toxic effects of the poison may change these processes directly. For example, absorption kinetics may be altered because of increased gastrointestinal transit time (e.g. cholinergic receptor antagonists) or saturable absorption (e.g. methotrexate). Saturation of protein binding may increase the volume of distribution and thereby increase the elimination half-life (e.g. salicylates). Alteration of the acid-base balance (poison-induced or iatrogenic) may also increase or decrease the distribution of a poison. Saturation of metabolism at high doses can prolong toxicity (e.g. phenytoin) or lead to other routes of metabolism that lead to increased toxicity (e.g. paracetamol [acetaminophen]). Excretion may be reduced by saturation of active transporters or decreased renal blood flow.A better understanding of pharmacokinetic principles should improve the clinical care of patients. It should lead to more accurate interpretation of blood concentrations or biomarkers (e.g. ECG intervals or acetylcholinesterase activity) and how these relate to the time course for that poison, and better prediction of prognosis. This in turn, indicates the appropriate duration of observation and the requirement for some specific treatments. Many specific poisoning treatments aim to favourably alter the pharmacokinetics of the poison. These include activated charcoal, whole bowel irrigation, extracorporeal elimination, chelating agents, antitoxins and urinary alkalinisation. The evidence supporting them, their indications and limitations can only be understood using pharmacokinetic principles. These principles also underpin the appropriate choice within the flexible dosage regimen for many antidotes. In particular, naloxone, flumazenil, methylene blue, atropine and pralidoxime all use variable doses and have an elimination half-life that is much shorter than many (but not all) of the poisons treated by these agents. A firm grounding in pharmacokinetics/toxicokinetics should be regarded as a core competency for all professionals involved in clinical care or undertaking research in clinical toxicology. 相似文献
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A Morice 《British journal of clinical pharmacology》1991,32(5):529-530