Towards a More Competitive Italy in Clinical Research: The Survey of Attitudes towards Trial sites in Europe (The SAT-EU Study TM)

M. Gehring, C. Jommi, R. Tarricone, M. Cirenei, G. Ambrosio
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引用次数: 7

Abstract

Background Italy is Europe’s third largest pharmaceutical market, yet it ranks only ninth in the number of NIH-registered clinical trials per capita. The aim of our study was to explore stakeholders’ perception of Italy as place to undertake clinical trials, and to estimate the potential economic impact of selected reforms in terms of incremental trial activity. Methods The Survey of Attitudes towards Trials in Europe (SAT-EU Study) was an anonymous, web-based survey which systematically assessed factors impacting clinical trial site selection in Europe. Estimates of Italian economic impact were developed in collaboration with AICRO (Association of Italian Contract Research Organisations). Results Responses were obtained from 485 professionals in 34 countries (15% residing in Italy) representing over 100 institutions, spanning BioPharma Clinical Research Organizations (CROs), and Academic Clinical Trial Units (CTUs). Italy ranked tenth of twelve in terms of accessibility and transparency of information required to run clinical trials, and last with respect to predictability and speed of Ethics Committees. Costs of running clinical trials were not considered critical, whereas, fragmented and slow approval process was. Streamlined centralized trial authorization would translate into an estimated 1.1 billion Euros of incremental trial investments over three years.  Conclusions Clinical trial professionals consider Italy’s governance of clinical research suboptimal, among the worst in Europe, and indicate that much could be done to make Italy more attractive for clinical trial investments. The present study also provides evidence about stakeholders’ willingness to invest in trials and its economic consequences provided effective reforms are put in place.  
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迈向更具竞争力的意大利临床研究:对欧洲试验地点的态度调查(SAT-EU研究TM)
意大利是欧洲第三大制药市场,但在美国国立卫生研究院注册的人均临床试验数量上,意大利仅排在第九位。我们研究的目的是探讨利益相关者对意大利作为开展临床试验的地方的看法,并根据增量试验活动估计选定改革的潜在经济影响。方法欧洲临床试验态度调查(SAT-EU Study)是一项匿名的、基于网络的调查,该调查系统地评估了影响欧洲临床试验地点选择的因素。意大利经济影响的估计是与意大利合同研究组织协会(AICRO)合作开发的。结果来自34个国家的485名专业人员(15%居住在意大利),代表100多个机构,涵盖生物制药临床研究组织(cro)和学术临床试验单位(ctu)。在进行临床试验所需信息的可及性和透明度方面,意大利在12个国家中排名第十,在伦理委员会的可预测性和速度方面排名最后。运行临床试验的成本不被认为是关键,然而,分散和缓慢的审批过程是关键。简化的集中试验授权将在三年内转化为估计11亿欧元的增量试验投资。临床试验专家认为意大利对临床研究的管理是次优的,在欧洲是最差的,并指出意大利还有很多工作要做,以使意大利对临床试验投资更具吸引力。本研究还提供了有关利益相关者投资试验的意愿及其经济后果的证据,前提是实施有效的改革。
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Epidemiology Biostatistics and Public Health
Epidemiology Biostatistics and Public Health PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH-
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期刊介绍: Epidemiology, Biostatistics, and Public Health (EBPH) is a multidisciplinary journal that has two broad aims: -To support the international public health community with publications on health service research, health care management, health policy, and health economics. -To strengthen the evidences on effective preventive interventions. -To advance public health methods, including biostatistics and epidemiology. EBPH welcomes submissions on all public health issues (including topics like eHealth, big data, personalized prevention, epidemiology and risk factors of chronic and infectious diseases); on basic and applied research in epidemiology; and in biostatistics methodology. Primary studies, systematic reviews, and meta-analyses are all welcome, as are research protocols for observational and experimental studies. EBPH aims to be a cross-discipline, international forum for scientific integration and evidence-based policymaking, combining the methodological aspects of epidemiology, biostatistics, and public health research with their practical applications.
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