Innovation

创新
  • 文章类型: Journal Article
    在科学研究的动态景观中,成像核心设施是推动技术开发和传播前沿合作和创新的重要枢纽。这里,我们提出了由全球生物成像(GBI)领导的合作努力,介绍旨在提升核心设施中成像科学家职业的国际建议。尽管成像科学家在现代研究生态系统中发挥着关键作用,在认识到它们的价值方面仍然存在挑战,调整绩效指标,并为职业发展和工作保障提供途径。挑战包括经典的学术职业道路和面向服务的角色之间的不匹配,导致缺乏对成像科学家和核心设施的价值和影响以及如何正确评估它们的理解。它们还包括围绕可持续性的挑战,专门的培训机会以及人才的招聘和保留。结构跨越这些相互关联的部分,本出版物中的建议旨在提出全球适用的解决方案来应对这些挑战。这些建议同样适用于在其他核心设施和研究机构工作的同事,通过这些设施和研究机构促进和支持获取技术。该出版物强调了成像科学家在推进研究计划中的关键作用,并为在世界各地的机构中促进他们的职业发展提供了蓝图。
    In the dynamic landscape of scientific research, imaging core facilities are vital hubs propelling collaboration and innovation at the technology development and dissemination frontier. Here, we present a collaborative effort led by Global BioImaging (GBI), introducing international recommendations geared towards elevating the careers of Imaging Scientists in core facilities. Despite the critical role of Imaging Scientists in modern research ecosystems, challenges persist in recognising their value, aligning performance metrics and providing avenues for career progression and job security. The challenges encompass a mismatch between classic academic career paths and service-oriented roles, resulting in a lack of understanding regarding the value and impact of Imaging Scientists and core facilities and how to evaluate them properly. They further include challenges around sustainability, dedicated training opportunities and the recruitment and retention of talent. Structured across these interrelated sections, the recommendations within this publication aim to propose globally applicable solutions to navigate these challenges. These recommendations apply equally to colleagues working in other core facilities and research institutions through which access to technologies is facilitated and supported. This publication emphasises the pivotal role of Imaging Scientists in advancing research programs and presents a blueprint for fostering their career progression within institutions all around the world.
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  • 文章类型: Journal Article
    根据世界卫生组织(WHO)抑郁症目前被认为是世界上最致残的疾病之一,是残疾调整寿命年最高的疾病之一[1],在COVID-19大流行期间,这种情况显然进一步恶化[2]。多达三分之二的重度抑郁障碍(MDD)患者在接受适当的一线护理标准后未达到完全缓解和/或出现焦虑等残留症状,认知受损,疲劳,睡眠障碍,或快感不足[3]。通常需要多次尝试才能找到最合适的治疗方法[4]。因此,需要具有更好功效的医药产品(例如,更快的行动开始,更高的反应率和缓解率),提高安全性和/或更个性化的配置文件[5]。
    According to the World Health Organization (WHO), depressive disorders are currently considered as one of the most disabling medical conditions in the world with one of the highest disability-adjusted life years [1] and this situation has apparently been further worsened during the COVID-19 pandemic [2]. Up to two thirds of patients with major depressive disorders (MDD) do not achieve full remission following an adequate first line standard of care and/or experience residual symptoms such as anxiety, impaired cognition, fatigue, sleep disturbance, or anhedonia [3]. Several attempts are often needed to find the most suitable treatment [4]. Thus, there is a need for medicinal products with better efficacy (e.g., faster onset of action, higher rates of response and remission), improved safety and/or more personalised profiles [5].
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  • 文章类型: Journal Article
    未经批准:在美国(美国),FDA监管医疗器械,大量多样化的医疗产品。仅在2020年,与几百种药品相比,至少有5000种新型医疗器械注册。据推测,内在力量,如FDA指南,可能会影响医疗器械的生产率。
    未经评估:对美国医疗器械指南进行了初步调查,借助那些药物作为定性比较。自第一个记录FDA医疗器械指南(1975年2月)到2010年代中期,医疗器械指南数量基本稳定,然后迅速上升。
    未经评估:COVID-19大流行和数字健康技术的兴起解释了自2010年代中期以来指南中50%的上升势头。同时,医疗器械和药物指南变得中度相关。这种观点认为,这种趋势将持续下去,而不管流行病的消退如何,因为它嵌入了“创新盐”的概念-即,离散的高度创新时期。这项工作的一个关键愿望是激发对监管科学这一有趣领域的更多研究;即。,审查准则(作为法规的替代措施)及其对创新的影响。
    UNASSIGNED: An initial investigation of US medical device guidelines is presented, with the aid of those of medicines as qualitative comparator. Since the first recorded FDA medical device guideline (February 1975) until the mid-2010s, the number of medical device guidelines has been basically stable, then rapidly rose.
    UNASSIGNED: The rise of the COVID-19 pandemic and digital health technologies explains 50% of the upward momentum in guidelines since the mid-2010s. Concomitantly, medical device and medicinal guidelines became moderately correlated. This perspective posits that this trend will continue irrespective of the ebbing pandemic as it is embedded in the concept of \'innovation saltus\' - i.e. discrete periods of elevated innovation. A key aspiration of this work is to inspire additional research into this interesting area of regulatory science; namely, examination of guidelines (as proxy measures of regulations) and their influence on innovation.
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  • 文章类型: Editorial
    暂无摘要。
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  • 文章类型: English Abstract
    目的:通过共识来衡量物理医学和康复(PM&R)医学专家的创新水平及其潜力。
    方法:使用数字工具应用了三种连续技术,以在专业人士之间达成共识,首先同步到一组17名专业人员;后面扩展到一组169名专业人员,他们异步参与,第三种技术与25名理疗师同步完成。
    结果:对PM&R医师在2020年10月和11月期间对该小组创新潜力的共识进行的分析显示:开始情况,优点和缺点,以及他们的创新优先事项。
    结论:PM&R医师认为创新可以提高科室的成本效益,可以提高他们的临床效率,此外,要创新,他们需要与行业建立密切的关系。
    To measure by consensus the level of innovation and its potential within the physical medicine and rehabilitation (PM&R) medical specialists.
    Three consecutive techniques are applied using digital tools for consensus among professionals, first synchronously to a group of 17 professionals; posteriorly extended to a group of 169 professionals who participate asynchronously and the third technique is done synchronously with 25 physiatrists.
    The analysis of the consensus done by the PM&R physicians on the innovation potential of the group during October and November 2020 shows: starting situation, strengths and weaknesses, as well as their innovation priorities.
    PM&R physicians believe that innovation could improve the cost-effectiveness of their departments, and could increase their clinical efficiency, also that to innovate they need a close relationship with the industry.
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  • 文章类型: Journal Article
    New discoveries and technologies are driving major advances in our understanding of cancer and underpinning a new era of precision medicine and immunotherapy. However, advances in treatment have been uneven: whereas survival rates for some common cancers are improving rapidly, for others there has been much less progress. In addition, healthcare systems are finding it difficult to provide access to expensive new treatments. There is an urgent need for imaginative policy solutions to incentivise the creation of novel therapies that address the full range of cancer-causing mechanisms. We have worked with organisations across the medical research community to develop consensus statements on how to enhance access to innovative cancer drugs. Here, we present our reflections on these statements.
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  • 文章类型: Journal Article
    A fixed-dose combination (FDC) is a drug product in which two or more separate drug components (active pharmaceutical ingredients) are combined in a single-dosage form. Interest in developing FDCs is increasing in a range of diseases. This project investigated the regulatory environment for FDCs in the EU and US. A review of the FDC guidelines set forth by the EMA, FDA, and ICH, followed by interviews of key informants in industry, identified 5 main industry concerns related to development of FDCs. These concerns were presented to key informants from both the EU and US regulatory authorities. It was clear from the results that the current regulatory environment for FDCs lacks consistency. This may create a barrier to innovation moving from the laboratory to the clinic, as companies cannot clearly see the development path requirements. This project also highlighted certain challenges that currently face the regulatory world: how to improve the role of regulatory science and provide clear quantification in assessment decisions; the role of guidelines and their impact on innovation; and, most important, the question of globalization and how to move toward a more harmonized regulatory system.
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  • 文章类型: Journal Article
    成年人根据他人行为在个体中的普遍性来推断他人行为的传统性。这里,我们看看孩子们是否使用行为共识作为惯例的线索,以及这是否告知儿童选择学习哪些文化模式。我们发现,2至5岁的儿童对行为共识的敏感性随着年龄的增长而增加,暗示像成年人一样,年轻人使用行为共识来识别社会习俗。然而,不像以前的研究表明,儿童倾向于喜欢和学习成员的共识,本研究表明,在某些情况下,儿童更喜欢并向非常规个体学习。讨论了这些不同偏好的含义。
    Adults make inferences about the conventionality of others\' behaviors based on their prevalence across individuals. Here, we look at whether children use behavioral consensus as a cue to conventionality, and whether this informs which cultural models children choose to learn from. We find that 2- to 5-year old children exhibit increasing sensitivity to behavioral consensus with age, suggesting that like adults, young humans use behavioral consensus to identify social conventions. However, unlike previous studies showing children\'s tendencies to prefer and to learn from members of a consensus, the present study suggests that there are contexts in which children prefer and learn from unconventional individuals. The implications of these different preferences are discussed.
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  • 文章类型: Journal Article
    The open-endedness of a system is often defined as a continual production of novelty. Here we pin down this concept more fully by defining several types of novelty that a system may exhibit, classified as variation, innovation, and emergence. We then provide a meta-model for including levels of structure in a system\'s model. From there, we define an architecture suitable for building simulations of open-ended novelty-generating systems and discuss how previously proposed systems fit into this framework. We discuss the design principles applicable to those systems and close with some challenges for the community.
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  • 文章类型: Journal Article
    Changing long-held beliefs is never easy. As a consequence of the accumulating clinical data and knowledge about the epidemiology and pathological mechanisms of the most frequent causes of morbidity and mortality, we are currently reconsidering our view of the origins and progression of cardiovascular, oncologic and neurodegenerative diseases. Optimistic versus pessimistic prognosis for healthcare sector depends much on diagnostic, preventive and treatment approaches, which healthcare systems will preferably adopt in the near future. PPPM offers great promise for the future practice of medicine. We are pleased to announce this first open access volume of The EPMA Journal following its transfer to BioMed Central two years after publication of the first article in the journal.
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