药物临床试验中研究人员职业安全现况调查分析

目的:分析药物临床试验过程中存在的影响研究人员职业安全风险的因素,提出整改措施,实现风险最小化。方法:分析某医院2010年—2017年的试验项目及研究人员职业安全影响因素。结果:研究人员中曾接触锐器及受试者血液体液35人,其中护士占57.14%,是职业安全风险的高危人群。研究人员中发生针刺伤者占31.82%,护士占54.55%,辅助科室技师占13.64%。69.64%研究人员未曾考虑过要对受试者血源性病原体进行全面筛查。结论:药物临床试验中研究人员是有职业安全风险的,加强药物临床试验相关知识及职业防护知识培训,完善受试者血源性病原体种类的检测可以减少和规避风险。     

药物临床试验受试者知情同意存在的问题及对策

药物临床试验在国内开展日渐广泛,但受试者权益保护却未能引起足够重视。本文分析了知情同意书设计、知情同意实施过程及签署中存在的不足,通过加强GCP法规培训、营造沟通氛围、提高质量控制等途径最大程度保障受试者的权益。     

早期抗肿瘤药物临床试验受试者风险管理

以保障受试者权益为核心,为提高药物临床试验质量,加快早期临床试验成果转化,保障临床试验进程,文章分别从早期药物临床试验中受试者权益保护及质量控制中的受试者管理两个方面探讨受试者的风险管理,并结合药物临床试验质控中受试者风险管理新模式提出受试者风险管理策略,以进一步提高临床试验主体在参与临床试验过程中对受试者的风险管理意识。     

见证中国

这是一群中国药物临床研究领域发展当之无愧的见证人。他们是在受试者身上进行临床试验的人员，一方面要完成临床试验的任务，另一方面又要负责受试者的医疗和安全，是对临床试验的质量和受试者安全，权利、健康和福利的负责者。解放军南京八一医院的秦叔逵教授希望我们好好宣传一下如何保护受试者的权益，提高医生对病人的人文关怀；     

Ⅰ期临床试验用药物的规范化管理

通过介绍我院Ⅰ期临床试验研究室试验用药物管理制度和标准操作规程,为其他Ⅰ期药物临床试验机构提供参考。强调试验用药的科学管理是药物临床试验过程中重要环节,药品管理员及参与临床试验的研究人员在试验药物的接收、保存、发放、使用、回收、返还等各个环节中均应严格按照SOP规范执行操作,从而保证临床试验的质量,保障受试者的权益。     

我国药物临床试验受试者保护问题研究

目的:促进药物临床试验受试者规范化管理,提出加强受试者保护的方法。方法:介绍国内外药物临床试验的发展趋势与我国药物临床试验中受试者保护的突出问题。结果与结论:我国药物临床试验市场潜力巨大,国外药物临床试验正逐渐向我国转移,我国受试者样本丰富且临床试验成本较低。但受试者保护存在诸多问题,如受试者在试验中处于弱势地位、需要承担巨大的风险、常易受到招募广告的误导、中途退出后权益得不到保证等。建议建立保护临床药物受试者权益的第三方组织,应用风险管理方法衡量受试者的风险受益比;伦理委员会应加强对药物临床受试者招募广告的审核,发挥研究者对受试者权益的保护作用等措施。     

浅谈我院药物临床试验准备阶段的工作体会

为保证药物临床试验结果科学可靠,保护受试者的权益并保障其安全,我们机构办公室遵照GCP精神,通过加强临床试验前的资料审核、确定项目负责人、配合伦理委员会审查、做好药物临床试验前的培训,规范研究过程,加强质量管理,不断提高临床研究水平。     

ISO9001质量管理标准在药物临床试验机构建设中的应用

目的:保证药物临床试验的质量和保障受试者的权益。方法:将ISO9001质量管理标准的基本原则、程序和方法,贯穿于我院国家药物临床试验机构的建设中。结果与结论:以ISO9001质量管理体系为铺垫,进行药物临床试验机构的建设,符合《药物临床试验质量管理规范》的要求,有利于保证药物临床试验的质量和保障受试者的权益。     

淋巴瘤药物临床研究全流程智能管理

淋巴瘤药物临床研究与日俱增,各种新兴的药物临床试验模式应运而生,其获益与挑战并存。本研究探索新形势下淋巴瘤药物临床研究智能化管理模式。基于我院现有的科研大数据平台和医院信息系统,结合AI技术和新版GCP等相关法规,我院设计并实施淋巴瘤药物临床研究智能化信息管理模式并不断进行优化,为临床试验全过程实施提供智能化管理支撑,可实现受试者智能筛选、智能标记、智能访视、智能监查、智能质控5个主要功能模块,为药物临床试验受试者和研究人员提供全流程研究工具与服务。2020年3月—2023年6月,我院已在4个淋巴瘤药物临床试验项目中使用智能筛选,12个淋巴瘤项目使用智能质控,利用药物临床试验受试者管理系统进行方案访视在线维护89项淋巴瘤临床试验项目,受试者筛选442例,受试者给药254例,按照受试者智能访视计划访视人数为158,受试者生存随访73例;远程监查在39例淋巴瘤药物临床研究中使用,总监查次数为8 890次。经过初步实践应用,该系统支持决策、辅助执行、规范临床试验流程、保障受试者权益、可提高药物临床试验管理效率和试验质量。初步达到了提质增效的预期目标,为淋巴瘤药物临床研究规范发展创造了有利条件...     

我国药物临床试验安全责任分属、问题及应对措施

新药临床试验是保证药品安全的关键环节。目前我国药物临床试验责任体系不够完善,细化临床试验参与各方责任对保证药品安全、促进药品创新、强化受试者权益有推进作用。本文在文献研究的基础上细化了包括研究者、申办者、伦理委员会和药品监督管理部门等相关人员的责任,提出完善我国药物临床试验责任体系的措施及建议。     

Clinical research in the elderly: ethical and methodological considerations

Clinically oriented research in the elderly is of growing interest because of increasing numbers of older persons, the relative lack of research data with this population, and recent Food and Drug Administration mandates to study drugs in the elderly. Studies of young, healthy persons cannot necessarily be extrapolated to the elderly due to changes associated with aging and the increased number of concomitant disease states and medications. Subject recruitment may be more time consuming in finding subjects with the appropriate inclusion criteria and lack of exclusion criteria who are willing to participate. Additional concern must be placed on protecting the subject's rights while allowing autonomous decision making. Likewise, protocols may need to be flexible enough to include persons with concomitant disease and medications.     

临床试验中特殊受试人群选择的国际伦理要求

弱势人群是指那些相对地(或绝对地)没有能力维护自身利益的人，即他们没有足够的权力、智力、教育、财力、力量、或其他必需的属性束保护他们的自身利益。邀请弱势个体作为受试需要特殊的理由，如果选择他们，必须切实履行保护他们权利和健康的措施。本重点论述了涉及儿童、因智力或行为障碍不能给予充分知情同意、妇女、孕妇等弱势群体生物医学研究的国际伦理要求。最后谈到研究是负担和利益并存的，任何群体或个人，包括弱势人群，都不应过多承担研究的负担，但也绝不能被排除在能使其受益的研究之外。     

The influence of the perceived home drug environment on college student drug use

The use of legal and illegal drugs at Ivy College, a small private liberal arts college in the West, was found to be directly related to four dimensions of the perceived home drug environment. These were perceived parental attitudes toward drug use, and perceived drug use of mother, father, and siblings. Perceived siblings' drug use was the most important of the four variables in its effect on subject's drug use. Relationships between the perceived home drug environment and subject's drug use were fairly strong where the drugs were the same in both instances, but weak when the drugs differed from home to subject's use.     

Drug Courts—Just the Beginning: Getting Other Areas of Public Policy in Sync

Although an offender can complete a drug court program in the United States, have his/her charges dismissed or reduced (or some other amelioration of the criminal justice system penalty that would otherwise have been applied), become drug free, obtain a job, regain custody of his/her children, become a tax-paying, law-abiding citizen, etc., he/she will still be deprived of basic rights afforded to other U.S. citizens because other sectors of public policy still approach addiction with a punitive orientation. Thus, despite the fact that an offender may have made a substantial beginning in recovery, other parts of the system make no accommodation for his/her recovery efforts in, for example, their denial of (a) welfare benefits to persons charged/convicted of drug offenses; (b) educational loans or other benefits to persons charged/convicted of drug offenses; (c) public housing to persons charged/convicted of drug offenses; and (d) voting rights to persons with felony convictions. In addition, deportation proceedings can be instituted—even for persons with a legal immigration status—based upon a charge or conviction for a drug offense.

Without changes in other key areas of public policy, the goals and benefits designed to be achieved by the criminal justice system through drug court programs can be thwarted in both the short and long term by the failure of a shift in thinking in other key public sector areas that are critical to meaningfully reintegrating substance-addicted offenders into the mainstream of the community. Hopefully, policy-makers will begin to address this critical need.     

Drug courts - just the beginning: getting other areas of public policy in sync

Although an offender can complete a drug court program in the United States, have his/her charges dismissed or reduced (or some other amelioration of the criminal justice system penalty that would otherwise have been applied), become drug free, obtain a job, regain custody of his/her children, become a tax-paying, law-abiding citizen, etc., he/she will still be deprived of basic rights afforded to other U.S. citizens because other sectors of public policy still approach addiction with a punitive orientation. Thus, despite the fact that an offender may have made a substantial beginning in recovery, other parts of the system make no accommodation for his/her recovery efforts in, for example, their denial of (a) welfare benefits to persons charged/convicted of drug offenses; (b) educational loans or other benefits to persons charged/convicted of drug offenses; (c) public housing to persons charged/convicted of drug offenses; and (d) voting rights to persons with felony convictions. In addition, deportation proceedings can be instituted - even for persons with a legal immigration status - based upon a charge or conviction for a drug offense. Without changes in other key areas of public policy, the goals and benefits designed to be achieved by the criminal justice system through drug court programs can be thwarted in both the short and long term by the failure of a shift in thinking in other key public sector areas that are critical to meaningfully reintegrating substance-addicted offenders into the mainstream of the community. Hopefully, policy-makers will begin to address this critical need.     

临床试验的伦理审查:精神障碍

精神障碍可能影响患者理解知情告知信息的能力,并可能影响他们做出参加临床研究理性决定的能力.对于涉及因精神障碍而不能给予充分知情同意受试者的临床研究,伦理委员会应该确保：在给予充分知情同意能力没有受损的人身上能同样好地进行研究,这类人就不能成为受试者;研究的目的是为获得有关精神障碍者特有的健康需要的知识;已获得与每位受试者能力程度相应的同意,可能的受试对象拒绝参加研究应始终受到尊重,除非在特殊情况下,没有合理的医疗替代方法,并且当地法律允许不考虑拒绝;如果可能的受试对象没有能力同意,应获得其法定代理人的许可.     

静脉吸毒人群前瞻性研究队列随访方法的应用

目的:探讨我国静脉吸毒人群前瞻性研究的方法.方法:于2002年11月,在四川省凉山地区从社区招募了HIV抗体阴性的静脉吸毒人群前瞻性研究队列333人.分析队列本底的静脉吸毒人群社会人口学和HIV高危行为特征,以及在6个月队列保持中各种随访跟踪方法的使用情况.结果:队列6个月随访阶段的保持率为74.8%(249/333)和HIV阳转率为4.04/100人年(95%CI: 0.50-7.59).通过种子通知、种子预约、种子或他人寻找和工作人员寻找为本研究队列6个月随访的主要方法.结论:在静脉吸毒人群研究队列随访中可考虑采用多种联系方式,其中通过外勤工作人员以及种子帮助来联系参加者为主要的队列随访方法.     

Exploratory planning and implementation of a pilot pharmacogenetic program in a community pharmacy

AIM: To describe the exploratory planning and implementation of a pilot pharmacogenetic program in a community pharmacy. An institutional review board-approved protocol for a clopidogrel pharmacogenetic program in a community pharmacy was developed to address feasibility and evaluate the pilot program. STUDY CONCEPT: Subjects taking clopidogrel are asked to participate at the point of medication dispensing. A pharmacist schedules an appointment with subjects to discuss the study and collects a buccal swab sample for CYP2C19 testing. When the results are available, the pharmacist consults with the subject's prescriber regarding test result interpretation and associated recommendations, and schedules a second appointment with the participant to discuss results and review any physician-approved therapeutic changes. The intervention-associated consultation is then billed to the subject's insurance. Results: Subject enrollment has begun. CONCLUSION: Community pharmacists may be valuable partners in pharmacogenetics.     

No effect of terodiline on anticoagulation effect of warfarin and steady-state plasma levels of warfarin enantiomers in healthy volunteers

The influence of terodiline (25 mg b.i.d.) on the anticoagulant effect and plasma levels of warfarin enantiomers was studied in 23 young healthy male volunteers. Racemic warfarin was first given for 24 days to determine the doses required for the subject's vitamin K-dependent coagulation factors to fall within 10-20% of the normal range, as determined by the Thrombotest. During continuous warfarin treatment (mean daily dose 5.3 mg, range 2.5-9.4 mg), terodiline or placebo was given for two weeks in a randomized and double-blind fashion, and then the drugs were crossed over and given for another two weeks. Terodiline did not influence the anticoagulant effect of warfarin or the plasma levels of the warfarin enantiomers. The results indicate that it should not be necessary to monitor patients on combined therapy with terodiline and warfarin more frequently than patients on warfarin monotherapy.     

Discounting in cost-utility analysis of healthcare interventions: reassessing current practice

Cost-utility analysis (CUA) is a technique that can potentially be used as a guide to allocating healthcare resources so as to obtain the maximum health benefits possible under a given budget constraint. However, it is not clear that current practice captures societal preferences regarding health benefits. In analyses of healthcare interventions providing survival benefits, the market rate of interest is the sole empirical variable that reflects societal preferences. This approach is based on the assumptions that: (i) healthcare interventions should be ranked using cost-effectiveness (CE) ratios; (ii) the discount rate for costs in CUA should be equal to that used in cost-benefit analysis (CBA); (iii) the discount rate in CBA should be the market rate of interest on long-term government bonds; and (iv) the Keeler-Cretin paradox is applicable to CUA of healthcare interventions, so that the discount rate for benefits in CUA should be set equal to the discount rate for costs. This approach ignores a fundamental difference between CBA and CUA, namely that CUA assumes that a budget constraint has been specified prior to the analysis. It starts with the assumption that a given amount of funds have been withdrawn from the economy to fund healthcare, so there is no opportunity cost to consider. For that reason, the principles on which the choice of discount rate rests differ in the two techniques. Furthermore, use of CE ratios to rank interventions assumes that the budget constraint can be expressed as a single constraint. But healthcare budgets are multiyear budgets that are roughly constant from year to year. A more realistic model would involve multiple constraints and would require linear programming for solution. This can be reduced to a series of single constraints, thereby allowing use of the simpler CE ratio approach, if we assume that the budget being allocated is intended for one cohort at a time, i.e. all people for whom a new funding decision must be made in a given year. In general, we assume that future cohorts will be allotted comparable funding. However, the Keeler-Cretin paradox depends on the assumption that cohorts are competing with each other for resources, and is therefore not applicable to CUA of healthcare. Other approaches are therefore needed to assign utilities to healthcare interventions providing survival benefits. Methods should be developed that allow analyses to reflect a range of philosophical approaches through sensitivity analysis.