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• 作者：姜小麦 发布时间：2012-03-06 14:10:50

  兴味索然

• 作者：惟见君读庄子 发布时间：2019-09-19 14:10:56

  《佛说海鸥乔纳森经》，一时，海鸥乔纳森·利文斯顿尊者性乐寂静，离群索居，行于海岸，修天足通，精进不已，了悟空性，得二大士接引极乐，从吉昂佛陀修行慈悲三昧，于焉发菩提心，终不忍舍弃此土众生，故倒驾慈航，广化有情。其弟子中最著名者，有亨利·凯尔文、马丁·威廉、查尔斯·罗兰德、特伦斯·罗维尔、克尔·梅纳德、朱迪·里等。其最能绍承增广乔纳森菩萨之事业者，当推福来奇为上首。

• 作者：释空 发布时间：2023-12-14 13:03:05

  每日一课，有收获

• 作者：Ranciere 发布时间：2021-05-16 09:09:36

  snobby

• 作者：张洋 发布时间：2019-10-07 12:28:51

  读中文版用来填一些自己不知道的知识点

• 作者：大草原 发布时间：2010-05-10 19:10:01

  2010.1

• 【《临床试验简史》书摘 & 中译英】开始的结束：临床试验工业革命（The End of Beginning: an Industrial Revolution of Clinical Trials 3.0）

  作者：南国椰风 发布时间：2022-05-22 18:15:48

  非常喜欢这本小书对医药临床试验娓娓道来的介绍，手痒翻译了下最后三页的部分，供大家一笑。翻译顺序是中文原文在上，本人的英文译文在下，阅读时敬请留意。

  工业化临床试验的操作模式是以研究机构为中心，研究机构扮演了试验的实施地和中转站角色。医生在研究机构招募和管理受试者，患者在研究机构接受治疗和随访。以这种模式开展多中心临床试验，涉及各研究机构的协调与管理，成本很高、效率很低。临床试验工业革命1.0和2.0，都是在不改变这种模式的基础上，利用社会分工精细化裂变出来的专业化组织和职业以及现代信息技术手段提供的产品，提高临床试验的效率和质量，降低临床试验的人力成本和物质成本。在这种固定模式里，作为受试者的患者，实质上是处于被动参与者的边缘地位。

  The operating mode of industrialized clinical trials is centered on research institutions, where trials are conducted and transferred. In the institutions, doctors recruit and manage subjects, while patients receive medical treatments and follow-ups. Carrying out multi-center clinical trials in this mode involves coordination and management of various research institutions, with high costs and low efficiency. Both 1.0 and 2.0 version industrial revolution of clinical trials were still based on this mode. They were aided by professional organizations from refined division of social labor and products offered by modern information technology. As a result, the revolutions just improved efficiency and qualities of clinical trials, lowered related human resource and material costs. However, patients as subjects are de facto passive participants, a marginalized position in this fixed mode.

  随着人们对健康要求的提高，以及大量医学新技术的涌现，临床试验逐渐成为满足人们健康需求的机会，而不是威胁。因此，人们对临床试验的关注焦点，从过去的保护受试者权益不受到侵害发展到现在的保障自己参加临床试验的权利不被剥夺。人类不再接受扮演一个被动参加临床试验的受试者角色，更倾向成为一个临床试验的发起者、设计者、组织者和管理者。因此，以患者为中心的临床试验模式开始兴起。

  With the increase of people's healthcare demands and booming of new medical technologies, clinical trials have gradually become opportunities meeting people's demands rather than threats. Therefore, people's focus on clinical trials has shifted from protecting subjects' rights and interests from infringement to reassuring unalienable chances to participate in such trials. Humans no longer accept playing the role of complete passive participants. Instead, they prefer to be the ones who initiate, design, organize and manage clinical trials. In this way, a patient-centered clinical trial mode began to emerge.

  以患者为中心，首先需要持续努力地让患者参加临床试验更加便捷。随着移动互联网技术发展，一种临床试验新模式开始出现，即跨越研究机构，由制药企业直接面向受试者的试验模式。这种新模式是基于手机APP或者可穿戴设备，以受试者为单位，直接收集数据，从而打破以研究机构为中心的固有模式。这一模式给患者带来很大的便利，有助于提高患者的依从性。这种基于移动端直接收集数据的临床试验，也可以是基于大数据的真实世界研究的一种。

  First of all, "patient-centered" means continuous efforts facilitating patients to participate in clinical trials. With the development of mobile Internet technologies, a new trial mode has been formed. In this mode, pharmaceutical companies design and carry out trials with subjects directly without research institutions. Taking each subject as a unit, this new mode collects data directly from patients based on smartphone apps or wearables, being a breakthrough from inherent mode centered on research institutions. It brings great convenience to patients, improving their compliance. And this type of clinical trials, based on direct data collected from mobile device, can be a living case of real-world study (RWS) on big data.

  比如，

  美国的Science37公司

  设计了

  一款称为NORA的APP平台

  。患者通过自己的智能手机或者平板电脑登录NORA后就可加入临床试验，并且和研究者医生进行交流。Science37会将研究药物运到患者家中，并帮助派遣护士或者医生到患者家中完成必要监测。同时，NORA将患者的数据安全地汇总到一个虚拟中心进行存储和分析处理。

  For example, Science37, a United States company, has designed a mobile App platform called NORA. Patients can join clinical trials simply by logging in NORA from their smartphones or tablets and communicate with investigating doctors. Science37 will deliver investigational drugs to the patients' homes, assigning doctors or nurses for necessary monitoring. At the same time, NORA collects and aggregates patient data into a virtual center for storage, analysis and processing uses.

  以患者为中心，不只是在临床试验数据收集的操作层面上的变革，还包括临床试验设计层面的理念转变。比如将患者更关注的效果指标如生命质量等纳入临床试验评价终点，而非仅仅关注注册所需的效能指标如生存期等。为此，需要在研究设计阶段，将患者纳入设计团队中来，听取并吸纳他们的关切。更进一步地说，现在更有特定患者自发地组成非政府组织，比如“罕见病患者组织”，主动寻找、发起和参与到适合特定患者人群的临床研究中去。

  Moreover, "patient-centered" not only covers operating level innovations of collecting clinical trial data, but also conceptual changes on the designing level of clinical trials. For instance, efficiency indicators concerning life quality shall be included into trial evaluation endpoints, rather than mere efficacy indicators like survival periods required for registration. For this reason, it is necessary to include patients into the design team, with their concerns listened and addressed. Further, there are specific patients establishing non-government organizations like "rare disease patient organization", who actively seek, initiate and join clinical trials suitable for specific patient populations.

  以患者为中心，更是在整个临床试验各环节，包括临床试验的发起、设计、知情同意、治疗、随访、评价等全流程实现向“以患者为中心”转变，最终达到“增强受试者对临床试验的主动参与和自我管理能力”的目的，重构整个临床试验的面貌，推动临床试验发展到“以患者为中心”的新时代。

  Finally, "patient-centered" means a full transformation across every step of a clinical trial, including initiation, designs, informed consents, treatments, follow-ups and evaluation. It would achieve the objective of "enhancing subjects' active participation and self-management capabilities in clinical trials", reshaping clinical trials inside out, and push the overall development to a new era of "patient-centeredness".

  工业化临床试验的行业生态圈包括CRO、SMO、各种临床试验相关产品及服务供应商等组织。在这个生态圈里，阶层式的传统组织是基本单元，绝大多数从业人员都是在这样的组织内部从业，积累职业经验；同时也频繁地跨越组织去寻求职业发展。总之，从业人员的职业生涯基本上离不开组织。随着临床试验技术的移动化、大数据化和智能化，以及临床试验向以患者为中心的模式转变，临床试验行业的组织模式也将发生相应变化，呈现出“去中心化”的趋势。

  The ecosystem of industrialized clinical trials comprises clinical research organizations (CRO), site management organizations (SMO), and various trial-related products or services providers. In this ecosystem, traditional hierarchical organizations are the fundamental units, where most practitioners work inside and accumulate professional experience; they also frequently jump between the organizations to seek career developments. Anyway, their careers cannot be separated from organizations. However, with the mobilizations, big data, intelligence of clinical trial technologies, plus the ongoing "patient-centered" transformation, the organization model within clinical trial industry will evolve accordingly, showing a trend of "decentralization".

  因为临床试验操作的移动化和智能化，从业者可以不再依赖组织提供的条件，能够实现更多的远程办公，从而导致临床试验工作模式的改变。同时，在以患者为中心的临床试验理念下，也逐渐减少了对研究机构的依赖。在这样的背景下，临床试验行业的职业生态将发生变化。CRA职业的职能可能逐渐向临床试验流程的上游发展，与数据治理或者项目管理融合；而贴近受试者终端的CRC职业则可能在未来成为这个行业的主流从业人群，特别是面对未来的纵向和横向连接所有患者的真实世界大数据研究的洪流。

  Thanks to mobilized and intelligent clinical trial operations, practitioners may no longer rely on what organizations offered. They are capable of more remote working, which leads to changes of clinical trial working modes. Also clinical trials are less dependent on research institutions under the "patient-centered" concept. In this context, the professional outlook of clinical trials industry will change. Functions of clinical research associates (CRA) may develop upstream to the clinical trial process, integrating with data governance or project management. The profession of clinical research coordinators (CRC) close to the side of subjects may be the mainstream practitioner population. In particular, they would be facing the flood of real-world big data connecting all patients horizontally and vertically in the future.

  更根本的问题在于，移动互联网时代实际上让人类走上了一条“去中心化”的不归路，而这种“去中心化”的指向符合人类解放人性的终极心理需求。因此，在临床试验的工业化时代建立起来的组织结构和行业生态圈也面临解构。原有的阶层式组织形态将向平台型组织变化，从业人群从组织内部的雇佣劳动者变成平台上的创业者或者自由职业者，“打工”二字可能成为历史。当然了，这还有赖于行业的进一步规范化和专业化。

  The more essential problem is, the era of mobile internet has led humans to a road of no return called "decentralization", which meets people's ultimate psychological demand of liberating humanity. In this way, organizational structures and industry ecosystems of clinical trials established during industrial time would face decomposition. The original hierarchical organizations form will change into platform structures. And practitioners, previously employed labors within organizations, would become entrepreneurs or freelancers on the platforms. The word "employment" may be history. Indeed, these changes rely on the whole industry to be further regulated and professionalized.

  总之，以大数据和智能化技术为中心，临床试验模式向“以患者为中心”转变，临床试验行业的组织“去中心化”、平台化，是临床试验工业革命 3.0 的特征。

  In conclusion, the focus on big data and intelligence technologies, the transformation towards "patient-centeredness", the decentralization and platform-evolving of clinical trial organizations, these are the symbols of industrial revolution of clinical trials 3.0.

  这一切，才刚刚开始。

  Everything is just beginning.

  第二次世界大战的阿拉曼战役是北非战场的转折点，以英国为首的盟军大胜。1942年11月10日，在伦敦市政厅里，在阿拉曼战役庆祝午宴上，英国首相丘吉尔发表了名为“The End of the Beginning”的著名演讲："Now this is not the end. It is not even the beginning of the end. But it is, perhaps, the end of the beginning."

  During World War II, El Alamein Campaign was the turning point in the battle field of North Africa, a triumph to allied forces led by Britain. On the celebration luncheon of Nov. 10th, 1942, the United Kingdom prime minister Winston Churchill delivered his famous speech titled "The End of the Beginning" in London City Hall. "Now this is not the end. It is not even the beginning of the end. But it is, perhaps, the end of the beginning."

  “这不是结束，甚至不是结束阶段的开始，而仅仅是开姶阶段的结束”，以此作为本书的结束。

  "Now this is not the end. It is not even the beginning of the end. But it is, perhaps, the end of the beginning." It is also the end of this book.

• 无剧透评论一下

  作者：子文东 发布时间：2022-09-27 16:39:31

  重要提醒：译者序里有严重剧透，强烈建议读完故事前先跳过。

  从主题的深刻性来看五星，阅读愉悦感四星。虽然在国内并没火起来，古尔纳给我的印象却比石黑一雄作为诺奖得主更当之无愧。因为他提供的视角在当下意义更深远，绝非套路宣传的所谓身份政治叙事——其实他讲的问题和每个人都仍然密切相关，因为揭示的是当代人所竭力回避的真相：与一个多世纪之前相比，精神的奴役和异己对峙仍然无处不在，身处其中者可能都不知道自己沦陷到了何种程度。即使以《天堂》来看，表面上他在讲一个世纪前的故事，可其实只是在通过还原历史可能的真实面貌，来让我们看清当下的处境和人的心理与被认定为“蒙昧”的过去是多么相似。

  比较微妙的是，阅读愉悦感四星，并不是由于作者笔力不行。从几处骤然悬浮于朴素叙事上的梦幻段落，可以明显看出作者如果想，能写得多美（比如主角归来后讲述旅行见闻的段落）。但大多数时候，作者都克制住了会显得机敏的表达，采用的是很古典的平白讲述，哪怕因此显得似乎平庸。我读到后面才明白，这种“拙”是为了让读者能跟随同样“拙”的主角，去经历从懵懂无知到苏醒的过程。梦幻的段落是苏醒的节点，其他部分他便努力避免炫技以取悦读者——像这样肯隐藏才气的作者，我一时间都想不到还有谁。

  不过话说回来，《天堂》的故事倒是和我之前以为的不同，虽然也有少年跟随商队旅行的故事，有不同族群杂居共处的背景，但风格完全不像阿米塔夫·高希，虽然我之前拿他俩类比不止一次。高希很浪漫，是基于当代人的审美和三观构建故事，所以戏剧性很强。但古尔纳更凝重得多，非常现实，他只是努力讲出真相，不会承诺道德理想或人生出路，甚至古尔纳故事里的矛盾冲突都是缓慢呈现的。我想他和高希的区别，也是纯文学和通俗小说的区别吧。读高希让我开心，但古尔纳显然能让读者思考更多，对自己和这个世界都更诚实。

  此外还有一个重要提醒：请千万不要一开始就读译者序！千万千万别看！还好我看开头就品出严重剧透味儿，赶紧跳过，否则真不知道看过那个几百字全情剧透后，再读这个故事还剩下多少滋味。搞不懂为啥要把剧透放在开头，要知道整个故事的核心张力，就在于主角对自身处境的无知，读者如果上来就啥都知道了，视野局限的“拙”也就被打破了，这种情况下还怎么可能保持足够的代入感呢？总之千万不要先读译者序！

  也是这个原因，虽然很想具体就里面一些人物和冲突细讲，也不得不忍住，只谈整体的阅读感受。而且这注定是一部比较挑读者的作品，我不敢说人人都会喜欢，但对于有耐心读朴素的故事，也思考过“自由”之“难”、之“罕见”的读者，古尔纳是非常非常值得推荐的。如果同时还对欧洲殖民者介入之前的那个非洲的真实面貌有兴趣，这本《天堂》也是极佳的“穿越”指南了。尽管此前已经有一点点了解，但阿拉伯人、印度人等因印度洋贸易迁徙而去的移民在非洲的影响力，还是超出了我的想象。得承认我们对历史的认知到底还是太西方中心主义，说这是一种“洗脑”或许有些严重，但仔细想想，确实有被“更文明”的表象所奴役却不自知的味道。