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美国营养学会ASN出版刊物鼓励作者使用LetPub编辑服务
LetPubSCI 2015-7-28 13:41
美国营养学会The American Society for Nutrition (ASN)在其官方网站上说,论文手稿应该用准确的、合乎逻辑的、以及语法正确的英语写作。编辑保留让没有用英语表达准确、清楚的手稿修改的权利。并且,再其官方网站鼓励相信其手稿能够从专业英语编辑中受益的作者使用 LetPub专业SCI论文编辑服务 。 ASN官方出版期刊—— The American Journal of Clinical Nutrition (ISSN:0002-9165)( IF=6.770 , JCR2014)《美国临床营养学杂志》, 是营养和饮食学领域名列第一的同行评议期刊。 本刊重点关注有关人类营养的基础和临床研究,内容包括:肥胖与饮食紊乱、心血管疾病风险、维生素、矿物质与植物活性成分、生长、发育与儿科、营养流行病学与公共健康。 The Journal of Nutrition (ISSN:0022-3166)( IF=3.875 , JCR2014)《营养学杂志》,创刊于1928年, 是同行评议的营养学研究期刊中最重要的刊物之一。 在ISI的营养和饮食科学类刊物中 名列前10%的TOP期刊。 期刊发表原始研究和评论,覆盖了广泛的营养学主题。 Advances in Nutrition (ISSN:2161-8313)( IF=3.875 , JCR2014),这在Thomson Reuters索引的 11149个期刊中前16%营养学大类排前20位。 详细信息可参考ASN官方网站: http://pubs.nutrition.org/site/misc/ASN_Language_Editing_Services.xhtml 关于ASN美国营养学会: 美国营养学会The American Society for Nutrition (ASN)成立于1928年,是美国营养学领域专业研究人员和从业人员的重要协会,出版三个营养学领域的国际领先期刊: The American Journal of Clinical Nutrition ( IF=6.770 , JCR2014)、 The Journal of Nutrition ( IF=3.875 , JCR2014)和 Advances in Nutrition ( IF=3.875 , JCR2014)。该协会是由美国实验生物学学会联合组成的学会之一,是一个通过科学的营养来改善人类生活质量的国际学术团体,总部设在美国加州。在全球有6个分会3个研究所。作为一家非盈利性的机构,学会一直致力于将世界上顶级的研究人员、临床营养学家、行业专家聚集起来,一起给人类、动物提供最新的营养知识。美国营养学会的宗旨除了汇集临床营养研究成果,还致力于将成果传播到世界。 关于LetPub: LetPub 是ACCDON(美国)旗下为非英语国家科研学者提供最优质SCI论文编辑和各类相关服务的专业品牌。在中国地区设立分公司五年来,LetPub 已经完成了两万多篇文章的编辑工作,绝大部分文章最终发表在SCI期刊上。其中不乏高影响因子的期刊,例如 PNAS , Journal of Neuroscience , Hepatology , Cancer Research , Journal of the American College of Cardiology , Chemical Society Reviews 等。 LetPub的使命是帮助世界各地的研究人员在国际著名期刊发表论文。我们提供专业的语言和学术编辑。LetPub有500多名专家编辑,都是PhD或MD。我们依靠丰富的智库资源和出版经验帮助作者排除出版过程中遇到的障碍。目前为止,有超过25000 篇论文接受过LetPub编辑服务。我们的语言编辑来自美国知名高校或学术机构,都是以英语为母语,具有长期的编辑经验。他们在各种科学、工程或技术领域具有专业或教育背景。
5010 次阅读|0 个评论
本土免疫肿瘤药Ⅰ期试验的澳洲之旅
热度 2 wsyokemos 2015-6-26 07:53
本土免疫肿瘤药 Ⅰ 期试验的澳洲之旅 | 正见 撰文:王守业 文字编辑:毛冬蕾 近几年,立志成为中国基因泰克的百济神州公司(下称百济),迅速崛起成为中国生物制药领域的明星企业。最近,百济通过媒体宣布,其在研的 3 个靶向型小分子新药在澳大利亚完成 Ⅰ期临床试验,研究结果明显优于同类药物。就在上个周,百济再传捷报:上述三个试验性新药之一的 BGB-3111( 靶向激酶 BTK 的抑制剂 ) 的 IND 申请获美国 FDA 批准,意味着该药不久将在美国正式开始 I 期临床试验。 除了小分子化学药之外, 百济的研发管线上还有一些大分子生物药,包括 3 个单克隆抗体药,其中两个靶向 PD-1 和 PD-L1 ,这两个靶点均为免疫检查点,是免疫肿瘤领域、乃至整个制药领域最为热门的两个靶点。 百济靶向 PD-1 单抗药为 BGB-A317 。该药的研发在上周获突破性进展:已开始在澳大利亚多家医院进行 I 期临床试验( ClinicalTrials.gov 注册号: NCT02407990 )。这是一个多中心,非盲、剂量递增和队列扩展试验, 该试验 已成功入组了第一位受试者,主要关注 BGB-A317 作为单药的安全性、耐受性、药代动力学和抗肿瘤的活性等属性。该试验的关键研究目的为确定 BGB-A317 药物的最大耐受计量、为 Ⅱ 期临床试验确定治疗计量、并初步了解其在不同瘤肿中的抗肿瘤效果。 根据公开资料显示,这也是中国本土研发的首个进入临床试验的抗 PD-1 单抗药。 这一重要进展也被国外多家媒体广泛报道。该临床试验百济方面的负责人是去年才加盟的 杨建新 (Jason Yang) 博士,他是百济高级副总裁监临床开发部首席总监。而百济另一个免疫抗肿瘤新药抗 PD-L1 单抗药已进入生产工艺开发阶段,预计明年会推进到 I 期临床试验阶段 。 值得一提的是,百济自从 2011 年创办以来,研发项目稳步推进。在短短 4 年时间里, BGB-A317 是第 4 个创新药进入临床试验阶段,其中有些还有望成为 最佳跟进新药( best-in-class )的潜力。 上述4个药目前还没有在中国境内开始临床试验,这并非百济的初衷,而是囿于国内审批法规的限制。 据百济的共同创始人王晓东对媒体介绍,已经在澳洲结束 I 期试验 3 个药物的临床试验申请,当初是在国内和澳大利亚同时递交的(上文提到的 BGB-A317 也申请了国内的临床试验)。 结果,后者在 5 个工作日内就批准了,国内则一直在 CFDA“ 排队 ” 。 包括百济在内的多家国内创新型制药公司选择在澳大利亚开展临床试验,是目前本土公司的一大趋势。这是由于澳大利亚至少有如下优势: 1)世界知名的医学研究中心和机构; 2)全球认可的医学标准和科研基础设施,可直接在欧美申请进一步临床试验或者上市申请; 3)相较于美国和欧盟国家,澳大利亚的临床试验费用和项目管理服务的费用更低; 4)按时完成的临床试验比例很高; 5)绝大多数在澳大利亚进行的临床试验无需经该国药监部门 (TGA) 批准,只需要伦理审查通过就可以,等待时间短,这对于竞争日益激烈的制药研发领域而言非常重要。为了容易记住澳洲的这些优势,笔者将上述5点中的最为重要的3点总结为三个字母,即 RCF ,众所周知, RCF 对于离心机而言,就是相对离心力的意思,在此处却是指: R ecognition(FDA 和 EMA 等认可 ) 、 C heap (相对便宜)和 F ast (审批快速)。 澳大利亚临床试验有两种管理模式:即临床研究告知制 ( C inicalTrial Notification, CTN) 和临床研究许可制 (Clinical Trial Exemption, CTX) 。 其中, CTN 占比最大 (99%) 。这种模式和国内临床试验的审批制度最大的不同点是, CTN 的批准是靠临床机构的伦理委员会,而不是 TGA( 澳洲的 FDA) 。伦理委员会负责申请的临床研究的技术性、伦理方面、安全性和有效性的审查,一般2 ~ 3个月内就可批准。 临床试验开始前,申办方只需告知 TGA ,无需其批准。所以澳洲的临床试验的审核和批准的大部分职责,交给伦理委员会和相关机构承担。临床研究告知制度大大加速了澳大利亚临床研究的审批进度,也吸引了周边国家的国际多中心试验项目。 回看百济,在研生物大分子类新药只有上述的 BGB-A317 一根独苗。相对于 3 个已结束了 I 期临床试验的小分子新药,显然生物大分子新药的研发进度落后些。 鉴于此,百济采取了一系列措施加快推进生物药的研发进度:首先,在不到一年内,先后和欧美著名的两家生物 CMO 公司 (BI Sigma-Aldrich 旗下的 SAFC) 签订合作协议。 其次,今年5月底,百济宣布入驻苏州生物产业园,该新基地将主要用作百济的小分子化学药的产业化和大分子生物药的中试研发。对于其中大分子生物药的中试研发基地,目前计划建成后用于支持百济在中国和全球进行的在研生物药的早期临床试验( Ⅰ期和Ⅱ期),因此这个基地自然也要符合 GMP 标准。这个基地尚未开建,仅仅在计划之中,以后也不排除会做出改变或调整的可能。 最后,闲聊几句百济的公司名,先说说其中文名,在笔者看来,百,意为 “ 很多,想方设法 ” ,济,意为 “ 悬壶济世 ” ,神州,等同于 “ 神州大地 ” 的中国,连在一起就是:竭尽全力为中国造好药,造福、救治中国病人。 百济的英文名 BeiGene 中的 Gene (基因),某种程度上显示了公司创立时的雄心大志,因为全球最著名、实力最强大的生物制药公司的公司名大都含有 Gene( 部分或全部 ) , 如: Gene nTech (基因泰克); Am gen ( 安进 ) ; Bio gen ( 此前的百健艾迪 ) ; Gen zyme( 健赞 ) ; Cel gene ( 赛尔基因 ) 。 这 5 家公司的总部均位于美国东西两海岸,其中基因泰克和健赞被欧洲的两家公司收购,不再是独立公司。被媒体誉为 “ 未来基因泰克 ” 的再生元公司,其美国公司的英文名字 Regeneron 尽管来源于 regeneration( 再生 ) ,仍可看出 Gene 的基因 (Re gene ron) 。全世界的公司名中含有 Gene 的公司为数众多,也许将来有一天,这些公司中最好的少数几家会发起成立 “ 基因俱乐部 ” ,百济或可跻身这个 “ 俱乐部 ” 。 版权声明:本文系原创文章, 2015 年 6 月 25 日发表于《研发客》。阅读原文可点击 文章链接 。版权 所有:王守业 《研发客》。请勿转载,如需转载,请联系 PharmDJ@outlook.com 获得授权。 推荐阅读百济神州相关博文: 百济神州在研的免疫抗肿瘤新药的前(钱)景如何? 百济神州何时在美国上市? 王晓东创办的百济神州再获巨额投资:将有近亿美元进帐 王晓东创办的百济神州:中国未来的基因泰克 ?
个人分类: 生物制药|12164 次阅读|2 个评论
百济神州在研的免疫抗肿瘤新药的前(钱)景如何?
热度 2 wsyokemos 2015-5-28 09:24
近日,在网上看到《人民日报》一篇报道:标题为 “ 做全球最好的抗癌新药 ” (链接不是人民网,是由于没有想到《人民日报》的网上文章居然还收费)、这是对王晓东的采访报道, 大赞其创办的百济神州公司 。 尽管我近几年一直关注百济,但文中的不少信息对我来说还是新的,相信对科学网的绝大多数网友而言,也是新的,所以本文就文中这些新料,谈谈自己粗浅的看法。 百济的临床实验进展 : “ 已有 3 个靶向型小分子新药在澳大利亚完成一期临床,所看到的疗效和副作用明显优于其它同类药物; 1 个免疫抗肿瘤新药已完成临床前研发,不久将在澳大利亚开展临床试验。 ” 上述三个靶向型小分子新药,我此前在另一篇博文有过介绍(参见: 王晓东创办的百济神州:中国未来的基因泰克 ? ),而 “1 个免疫抗肿瘤新药 ” 就是靶向 PD-1 的单克隆抗体药,这个的靶点堪称是当今世界上最热门的药物靶点,竞争非常激烈。这个靶点我在去年的一篇博文有过介绍(参见: 抗癌新药最火的分子靶点-兼议肿瘤免疫治疗 ), 这么热门,当然是由于疗效好,肿瘤免疫治疗被认为是继手术、放疗、化疗和靶向治疗之后的又一革命性治疗方式。目前免疫治疗的最新前沿可以说有点 “ 二 ” ,因为描述这个进展有太多的 “ 二 ” 。 1 )两个公司:目前,在免疫治疗领域最领先的两家公司是百事美施贵宝 (BMS) 和默沙东,位于第二梯队的也有两家公司:罗氏和阿斯特拉 (AZ) ,如果论进展, 百济连第三梯队都算不上(尽管在这个领域,百济是国内公司中最领先的); 2 )两个药: BMS 的 Opdivo 和默沙东 Keytruda 都已经获批上市; 3 )两个国家:这两个药目前只在两个国家获批:即日本和美国; 4 )两个适应症: Opdivo 目前已经获批两个适应症:黑色素瘤和肺癌; Keytruda 只在美国获批且只有一个适应症:黑色素瘤。 制药领域有一种所谓的 “Pick the winner” 的研发策略,这一策略在上述 Opdivo 和 Keytruda 两个药上表现的淋漓尽致: BMS 的 Opdivo 目前有近 90 个临床实验正在进行,用于实验超过 20 种癌症,默沙东的 Keytruda 更是有上百个临床实验在进行,显而易见,两家公司针对同一个靶点的抗体药都在投入巨资快速大规模推进临床实验,将两个药的潜力充分挖掘,所以两家公司真的都蛮拼的,相信这两种药会有更多的适应症获批。综上所述, 百济神州在国际市场上,尚未进行临床实验的 “ 免疫抗肿瘤新药 ” 的 前(钱)景似乎并不光明。百济要想在免疫肿瘤这个未来的大市场分一块蛋糕并不容易,它的前面还有不少很强的竞争对手。百济目前要做的,就是加速推进临床实验进程,而临床实验,尤其是国际 II-III 期实验,是很烧钱的,尽管 “ 百济神州已在国内外资本市场上获得 2 亿美元投资 “ ,但是如果要想大规模开展临床实验, 2 亿美元并不够花,所以,百济目前在准备在美国上市(参加我的另一博文: 百济神州何时在美国上市? ), IPO 后融资会使百济有更好的财力进行临床实验。 另外, 暴富的百济也曾经穷过 ,联合创始人王晓东对记者介绍到: “ 我们开始研发的四五个项目都失败了,企业最困难的时候账上只有 1 万多块钱。多亏了欧雷强满世界借钱,才度过了难关。 ” 。 百济神州的新药也遭遇了 CFDA 的中国式审批 ,尽管这是已经久被制药界诟病的老问题,但是这一问题通过颇有影响力的王晓东和《人民日报》说出来,分量就不一样了。摘引原文报道: “ 困难对我来说不是问题。 ” 王晓东说, “ 我唯一感到难受的,是我们研发的新药不能让国内患者很快用上。 ” 来, BGB-283 等 3 个药物的临床试验申请是在国内和澳大利亚同时递交的。结果,后者在 5 个工作日内就批准了,国内则一直在 “ 排队 ” 。据介绍,由于我国药品临床试验审批过程异常缓慢,这 3 个新药在国内至今尚未获准开展临床。进展最快的 BGB-283 ,光在国家食药监管总局药品评审中心( CDE )光 “ 排队 ” 就花了 1 年多,到今年 2 月才进入评审,最快要到下半年才能开展一期临床。其余两个药物还在 “ 排队 ” ,不知等到什么时候才能进入评审。” 相信 CFDA 也感到了压力,估计以后新药审批速度以后会加快,政策之一就是向美国的 FDA 学习,大幅增加新药注册费来增加人手和聘用外部审评专家,以加快审评速度。就在昨天 (5 月 27 日 ) , CFDA 发布 2015 年第 53 号公告,临床实验新药注册费 (IND) 调整为:国产: 19.2 万元,进口为 37.60 万元,生产/上市临床实验新药注册费 (NDA/BLA) 为:国产: 43.20 万元,进口为 59.39 万元。新药注册费均大幅上涨, CFDA 目前的蜗牛式中国审评速度已经不仅阻碍了中国创新药的研发速度,和国际先进水平的距离越来越大,也使中国患者不能及时用到救命药,所以,于国于民都是大大的不利。 另外,需要指出的是,《人民日报》的这位记者也许不是制药领域的内行,文中有多处错误 (尽管都不是硬伤),其中之一是 “ 默克旗下的生物制药公司雪佛兰与百济神州签署协议 ” ,这家公司就是默克雪兰诺 (Merck Serono) ,雪佛兰 (Chevrolet) 则是美国通用汽车公司的著名汽车品牌。 本文主要经删改和增添内容后, 2015 年 6 月 5 日发表在新媒体《研发客》上,标题为 免疫肿瘤药的三大梯队 。感谢《研发客》毛冬蕾主编对此文的贡献和专业修改。 后记:经默沙东的一位员工确认,截至 2015年6月11日, 默沙东的Keytruda已被如下国家和地区批准上市(适应症为黑色素瘤):澳大利亚、以色列、韩国、澳门、阿联酋和加拿大。
个人分类: 生物制药|12072 次阅读|4 个评论
埃博拉疫苗能“治”埃博拉吗?
热度 5 wsyokemos 2014-9-1 00:58
本来我打算以后不再写有关疫苗的博文了,然而,近日看到一些中文媒体(甚至也包括科学网的一些相关博文)上的一些不准确的报道,觉得如鲠在喉,不吐不快。本文力图厘清两个问题: )正在试验阶段的埃博拉疫苗以后能“治疗”埃博拉吗?; 2 )这些将要进行临床试验的埃博拉疫苗必须要进行 I 期到 III 期所有阶段的临床试验吗? 下面先来看第一个问题,最近不少中文媒体将埃博拉疫苗和正在试验的埃博拉治疗性药物 ( 包括抗体和 siRNA) 混为一谈,认为埃博拉疫苗也能治疗埃博拉,但是埃博拉疫苗对于埃博拉只有预防作用,并无治疗作用。对此,美国《福布斯》杂志近日有很好的深入报道【 1 】,比如葛兰素史克 (GSK) 公司和美国 NIH 下属的 NIAID 研究所合作研发的埃博拉疫苗即将在美国和英国展开临床试验。该疫苗的作用原理大致如下:首先受试者接种含有能表达埃博拉病毒关键蛋白基因的病毒载体,然后该载体即可在人体产生能中和埃博拉病毒的抗体,从而达到预防埃博拉病毒的目的。这种疫苗之所以采用相对稳定的病毒载体而非直接注射重组蛋白,我个人推测大概是由于基于蛋白的疫苗需要全程冷链储运,这对于非洲绝大多数国家(也是 埃博拉最主要的施虐地 )而言都很难做到。一般而言,疫苗都是所谓的“治未病”,或更确切地说是“预防”病。并且,由于人体的免疫系统产生抗体需要时间,如果没有足够的时间,接种的疫苗也无法起作用,比如如果当天接种疫苗,当天就受到埃博拉病毒感染,疫苗自然也无法起到保护、预防的作用。 另外需要说明的是,虽然说疫苗“一般”都是预防性的,而非治疗性的,但是既然说是“一般”,当然就有“二般”,有例外。比如,四年前( 2010 年)美国 FDA 就批准了全球第一个治疗性癌症疫苗 sipuleucel-T ( 商品名: Provenge) 【 2 】。迄今, FDA 批准上市的治疗性疫苗也只有寥寥几种,绝大多数 疫苗 还都是传统的预防疫苗 (超过 70 种,参见我的另一博文: 盘点美国 FDA 批准的人用疫苗和我的疫苗博文 )。 下面再来看本文试图回答的第二个问题:上述将要进行临床试验的埃博拉疫苗一定要进行 I 期到 III 所有临床试验吗?简单的说,答案是否定的。一般而言,预防性疫苗也需要像药物(或治疗性疫苗)一样需要进行 I-III 临床试验,以证明其安全性和有效性。这些试验可以在疾病自然发生状态下(如正在进行的许多 HIV 疫苗临床试验),也可以是在接种疫苗后再进行主动感染试验。但是这两种模式,对于有些疾病尤其是适用于生物恐怖(或生物武器)的,就不适合,因为像埃博拉或炭疽病根本就无法预知它何时会爆发、流行,对于健康受试者显然也不能像做动物试验那样感染致命的埃博拉病毒(当然,当年的日本 731 部队不管这些),这自然不符合科研伦理。而人类也亟需这些疫苗,如何破解这个难题呢?美国 FDA 提出了动物规则 ( 即: Animal Rule) 作为一种折中方案,对于这个规则,我相信科学网绝大多数人并不了解,一般公众更是一无所知。所以,本文简单介绍一下, 当然我自己也是现学现卖。美国 FDA 的一位专家(这个还真不是“砖家”)在 2012 年时发表专文,详细介绍了这个动物规则【 3 】,这个规则不是疫苗上市的捷径,只适用于极少的情况(如炭疽病、鼠疫和埃博拉等),需要完全同时满足如下四个基本条件: 对于疫苗毒性的病理机制和疫苗的预防作用要有足够了解; 其预防作用一般要在一种以上的动物进行活体试验; 动物试验的终点需要要和人所期待的益处(如降低致死率)清楚的相关; 要充分理解试验疫苗在动物和人的药物代谢动力学 (PK) 和药效学 (PD) 数据,以选择人用的有效剂量。 埃博拉疫苗显然适用于动物规则,简单的说,我个人的理解是,埃博拉试验疫苗尽管仍然需要 I 期临床试验来测试疫苗的安全性,但是无需、也无法完成传统的 II 期和 III 期临床试验。 另外,我国在抗击埃博拉中似乎也有突破,近日有报道说 “ 我国首个抗埃博拉药获批 ” ,但是 “ 限紧急情况使用 ” 【 4 】。对于这个药物 (jk-05) 和新闻,我有几点简单评论和疑问: 1 )报道称 “jk-05” 是一种小分子化学药物,该药能够选择性地抑制埃博拉病毒的 RNA 聚合酶,从而达到抑制病毒复制的目的 ” ,目前国际上治疗埃博拉病毒的实验性药物均为生物药(抗体和 RNAi ) , 我个人判断埃博拉病毒 RNA 聚合酶并非是这个小分子化学药非常是特异性靶点(正如文中报道的,最多是 “ 选择性 ” )。所以副作用估计小不了; 2 )该药是通过了 “ 总后卫生部专家评审 ” 而不是国家食品药品监督总局的审批,所以获得的是 “ 军队特需药品批件 ” ,简单的是说,是军队专用; 3 )该报道还称 “ 研究表明,该药在细胞和动物水平感染试验中具有抗埃博拉病毒活性。专家特别强调,该药物虽已完成临床前研究 ” 。我不理解的是,我国连埃博拉病毒都没有,怎么做的感染试验?就算军方有秘密的埃博拉病毒,整个中国大陆连一个投入使用的生物安全四级实验室都没有,埃博拉病毒感染实验室如何做的?在三级实验室做?如果果真如此,这可是在拿科研人员的生命在冒险,同时对公共安全也构成威胁; 4 )网上搜了一下 jk-05 这个药,貌似只有印度和巴基斯坦等少数几家发展中国家的媒体或网站报家道了这个药物和上述新闻,但是欧美主流媒体鲜有报道。 相关阅读: 埃博拉病毒会是理想生物武器吗? 盘点全球生物安全顶级实验室 (BSL4,P4) 主要参考资料 : GSK/NIAID Ebola Vaccines To Enter US, UK Human Safety Trials , http://www.forbes.com/sites/davidkroll/2014/08/28/gsk-niaid-ebola-vaccine-to-enter-uk-human-safety-trials-broad-international-collaboration/ FDA Approves First Therapeutic Cancer Vaccine , http://www.cancer.gov/ncicancerbulletin/050410/page2 Burns, Drusilla L. Licensure of vaccines using the Animal Rule. Current opinion in virology 2.3 (2012): 353-356. 我国首个抗埃博拉药获批 限紧急情况使用, http://news.sciencenet.cn/htmlnews/2014/8/302372.shtm
个人分类: 生物制药|8504 次阅读|12 个评论
[转载]TCGA clinical dataset description
aaa0 2013-8-18 00:05
TCGA clinical dataset description IF you are interested in TCGA clinical dataset, Please refer to the following key. For summarygrade: low = 1, 2, LMP. High= 3,4,23. For summarystage: early = 1,2, 12. late=3,4,23,34. For T: Stage (1-4). If multiple stages given (eg 34), use thehighest. For substage: substage (abcd). For cases like ab, bc, use highest given. For G: Grade (1-4): If multiple given, ie 12, 23, use highest given. For N: N (0/1): degree of spread to regional lymph nodes. For M: M (0/1): presence of metastasis. For pltx: patient treated with platin. For tax: patient treated with taxol. For neo: patient treated with neoadjuvant treatment. For primary_therapy_outcome_success: response to any kind of therapy (including radiation only). For chemo_response: platinum resistance: refractory=3mo or less, resistant=6mo or less, sensitive=12mo or higher. For inferred_chemo_response: inferred platinum resistance: refractory=death in 6mo or less, sensitive=survival for 12mo or more. For debulking: amount of residual disease (optimal =1mm, suboptimal=1mm).
2175 次阅读|0 个评论
[转载]QIAGEN‘s Clinical NGS effort
genesquared 2012-11-21 09:52
QIAGEN unveils initiative to create next-generation sequencing portfolio for use in clinical research and molecular diagnostics http://www.qiagen.com/about/pressreleases/pressreleaseview.aspx?PressReleaseID=384 Aim to expand next-generation sequencing beyond current focus on life sciences research QIAGEN plans to offer sample-to-result workflows that integrate its sample preparation and assay products with a next-generation benchtop sequencer and new bioinformatics Initiative combines broad range of QIAGEN products with acquisition of sequencing specialist Intelligent Bio-Systems, Inc. and a new strategic collaboration with SAP AG HILDEN, Germany, and GERMANTOWN, Maryland, USA, June 25, 2012 - QIAGEN N.V. (NASDAQ: QGEN; Frankfurt Prime Standard: QIA) today unveiled an advanced initiative to enter the field of next-generation sequencing (NGS) that aims to establish these technologies as routine processes used in new areas such as clinical research and molecular diagnostics . QIAGEN is in the advanced stages of creating sample-to-result, efficient and cost-effective NGS workflow solutions. These will combine a broad range of QIAGEN products - including automated sample preparation solutions ( nucleic acid extraction, DNA enrichment, library preparation and targeted gene analysis panels) - with a previously undisclosed next-generation benchtop sequencer in development with Intelligent Bio-Systems, Inc., a privately held company that QIAGEN has acquired. New bioinformatics, including solutions emerging from a new collaboration with SAP AG, will be incorporated into the workflows. A first sample-to-result NGS solution is expected to be launched next year, while details on specifications and launch plans are set to be released in early 2013. "The rapid advances in next-generation sequencing have enabled life science researchers to unlock many secrets about the molecular building blocks of life. Our ambition is to create a new dimension of benefits for these technologies by offering workflow solutions for clinical use, particularly to develop new medicines and improve healthcare with advanced diagnostics," said Peer M. Schatz, CEO of QIAGEN N.V. "While next-generation sequencing is viewed today mainly as a research tool, our initiative is to expand beyond this and to offer applications designed to address the needs of customers in clinical research and molecular diagnostics ." Key elements of this initiative include: Content: The development of a broad portfolio of gene panels designed for NGS analysis based on QIAGEN's extensive offering of molecular content, including GeneGlobe (www.geneglobe.com), an online portal that offers access to more than 60,000 well-defined and characterized molecular assays. In the first wave, QIAGEN plans to offer eight preconfigured gene panels for use in cancer, as well as enable customers to create customized panels for specific molecular pathways and diseases. Sample technologies: An extensive range of NGS sample preparation products is planned to be launched that are based on QIAGEN's global leadership position in sample technologies and enzymology. NGS module: A previously undisclosed NGS benchtop sequencer is in late stages of development with Intelligent Bio-Systems, Inc. (IBS), a privately held U.S. company that QIAGEN has acquired. This novel system can process multiple samples in parallel with highest flexibility and performance, and benefits from the use of proprietary sequencing by synthesis (SBS) technology exclusively licensed from Columbia University. Building on elements of previous IBS designs as well as on QIAGEN technologies, this new system - which is expected to enter beta testing with customers in 2012 - seeks to offer a new dimension of benefits and cost savings. Key features include new sample technologies and software as well as the ability to process up to 20 individual samples in parallel without a need for pooling and bar-coding, which can result in significant time and cost savings in clinical sequencing . Its design allows for flow cells and reagents to be loaded continuously while in operation, and also for up to 20 different assay types to be processed simultaneously and in random order. Many of these features - particularly the parallel processing of multiple samples and continuous loading of reagents and random samples - are considered essential for clinical sequencing . Two automation alternatives are being developed in combination with QIAGEN platforms to create workflow solutions from biological sample through to final result. One workflow integrates the NGS module into the QIAsymphony automation family, while a second is based on the QIAcube automated sample preparation system. Both workflows will offer extensive bioinformatics, including from the SAP collaboration. Financial terms of the IBS acquisition, which was completed during 2012, were not disclosed. "We are very excited to join forces with QIAGEN, which is an ideal partner to bring our new ultra-low cost sequencing technologies to the market as part of a complete workflow that will expand our product's use into new areas," said Steven J. Gordon, Ph.D., CEO and founder of Intelligent Bio-Systems. "We can deliver greater value to our customers from our novel technologies by leveraging QIAGEN's leadership in sample preparation, advanced gene panels and global reach along with the bioinformatics expected to emerge from the collaboration with SAP. Our goal is to better address the demands of clinical and core lab customers for complete solutions, since many have been struggling to adapt existing sequencing platforms to their workflows." Bioinformatics: SAP and QIAGEN are collaborating on bioinformatics efforts aimed at significantly reducing the time required for the analysis of sequencing data. The basis for the collaboration will be to apply the breakthrough SAP HANA ® platform in next-generation sequencing interpretation. Reducing this time period is seen as an important factor in driving greater use of sequencing technologies in new areas and reducing overall operating costs. "Rapid and accurate sequencing , assembly and interpretation of genomes represents a great challenge of our times in healthcare," said Dr. Vishal Sikka, member, Executive Board, SAP AG. "SAP HANA brings a dramatic acceleration to the data analysis challenges at the heart of genomics . We at SAP are very excited to collaborate with QIAGEN on this extraordinary opportunity to transform the biological sciences and help improve people's lives." QIAGEN intends to offer this new product portfolio across all of its customer classes, with priority focus on clinical research in Academia and Pharma as well as in some Molecular Diagnostics franchises, including select areas of Personalized Healthcare. The next-generation sequencing market, which up to this point has been driven primarily by life sciences research, is estimated to be more than $1 billion a year and growing rapidly as the use of these technologies expands into new areas. QIAGEN is a pioneer in enabling the use of biomarker data to guide treatment decisions through companion diagnostics based on real-time PCR technologies as well as a portfolio of sequencing -based diagnostic assays based on its Pyrosequencing ® technology. Together with its portfolio of next-generation sequencing technologies, QIAGEN can offer customers workflows that include the widest range of sample technologies to collect and process nucleic acid samples as well as leading assay and data analysis technologies for use across its customer classes in Academia, Pharma, Applied Testing and Molecular Diagnostics . The adoption of next-generation sequencing in clinical research and molecular diagnostics is still hampered by workflow challenges, particularly time required for data analysis as well as regulatory uncertainties and sequencing costs. The various features in this initiative seek to address these challenges, and could lead to NGS technologies being adopted in certain areas such as exploratory diagnostics, the diagnosis of complex diseases and treatment of cancer patients. NGS technologies are also expected to complement established routine molecular technologies such as real-time PCR . QIAGEN currently anticipates the investments planned to create this new NGS portfolio to be dilutive to adjusted EPS (earnings per share) by approximately $0.01 for full-year results in 2012 and by approximately $0.02 in 2013, but to be accretive to full-year results in 2014. About QIAGEN: QIAGEN N.V., a Netherlands holding company, is the leading global provider of Sample Assay Technologies that are used to transform biological materials into valuable molecular information. Sample technologies are used to isolate and process DNA , RNA and proteins from biological samples such as blood or tissue. Assay technologies are then used to make these isolated biomolecules visible and ready for interpretation. QIAGEN markets more than 500 products around the world, selling both consumable kits and automation systems to customers through four customer classes: Molecular Diagnostics (human healthcare), Applied Testing (forensics, veterinary testing and food safety), Pharma (pharmaceutical and biotechnology companies) and Academia (life sciences research). As of March 31, 2012, QIAGEN employed approximately 3,900 people in more than 35 locations worldwide. Further information can be found at http://www.qiagen.com/ . About Intelligent Bio-Systems, Inc.: Intelligent Bio-Systems, Inc. was founded in 2005 by Dr. Steven Gordon and Dr. Jingyue Ju to commercialize advanced sequencing technologies and patents from Columbia University. Next-generation sequencing refers to methods of analyzing DNA that began to emerge in the 1990s to improve upon earlier sequencing approaches that were time-consuming and laborious. Intelligent Bio-Systems' newer generation of sequencing by synthesis (SBS) technology incorporates proprietary advances in DNA sequence readout and DNA sample preparation, enabling low-cost, high throughput sequencing with high-quality data, making it attractive for customers.
个人分类: Qiagen|1724 次阅读|0 个评论
外科类领域易发表杂志总结
zlhtcm 2012-11-1 23:04
World J Surg 2010收稿量:417 2010IF:2.693 杂志国家:United States 发表周期:12 issues per year 投稿网站: http://mc.manuscriptcentral.com/wjs 审稿周期:1-2 months 投稿经验总结:发表的文章主要集中在major clinical problems in the fields of clinical and experimental surgery, surgical education, and socioeconomic aspects of surgical care方面。中国的文章不是很多。 Am J Surg 2010收稿量:277 2010IF:2.680 杂志国家:United States 发表周期:12 issues per year 投稿网站: http://ees.elsevier.com/ajs/ 审稿周期:1-2 months 投稿经验总结:发表的文章主要集中在abdominal, cancer, vascular, head and neck, breast, colorectal, and other forms of surgery。每期1-2篇中国人的文章。 Plast Reconstr Surg 2010收稿量:412 2010IF:2.635 杂志国家:United States 发表周期:12 issues per year 投稿网站: https://www.editorialmanager.com/prs/ 审稿周期:1-3 months 投稿经验总结:主要发表的文章为Significant papers on any aspect of plastic surgery—original clinical or laboratory research, operative procedures, comprehensive reviews, cosmetic surgery。每期有2-3篇中国人的文章。 J Refract Surg 2010收稿量:109 2010IF:2.491 杂志国家:United States 发表周期:9 issues per year 投稿网站: https://www.rapidreview.com/ 审稿周期:2-4 months 投稿经验总结:主要发表original research, review, and evaluation of refractive and lens-based surgical procedures。中国人的文章不多。 Injury 2010收稿量:307 2010IF:2.269 杂志国家:Netherlands 发表周期:12 issues per year 投稿网站: http://ees.elsevier.com/jinj/ 审稿周期:2-3 months 投稿经验总结:主要发表all aspects of trauma care and accident surgery。每期有1-2篇中国人的文章。 Dermatol Surg 2010收稿量:296 2010IF:2.264 杂志国家:United States 发表周期:12 issues per year 投稿网站: http://mc.manuscriptcentral.com/ds 审稿周期:1-3 months 投稿经验总结:主要发表 cosmetic and reconstructive skin surgery and skin cancer; e.g. Cutaneous Laser Surgery, Soft Tissue Fillers, Skin Resurfacing, Hair Transplantatio, Phlebology, Liposuctio, Skin Cancer Surger. Reconstructio。中国人的文章不多。 J Surg Res 2010收稿量:351 2010IF:2.239 杂志国家:United States 发表周期:14 issues per year 投稿网站: http://ees.elsevier.com/jsurgres/ 审稿周期:2-3 months 投稿经验总结:主要集中在reports of clinical investigations or fundamental research bearing directly on surgical management that will be of general interest to a broad range of surgeons and surgical researchers。每期有1-2篇中国人的文章。 Clin Orthop Relat Res 2010收稿量:422 2010IF:2.116 杂志国家:United States 发表周期:12 issues per year 投稿网站: http://www.editorialmanager.com/corr/ 审稿周期:3-4 months 投稿经验总结:主要集中在all aspects of musculoskeletal research, diagnoses, and treatment。中国的文章不多。 Knee Surg Sports Traumatol Arthrosc 2010收稿量:282 2010IF:1.857 杂志国家:Germany 发表周期:12 issues per year 投稿网站: https://www.editorialmanager.com/ksst/ 审稿周期:2-4 months 投稿经验总结:主要集中在 all aspects of knee surgery and all types of sports trauma epidemiology, diagnosis, treatment and prevention, and all types of arthroscopy中国的文章不多。 J Plast Reconstr Aesthet Surg 2010收稿量:452 2010IF:1.660 杂志国家:Netherlands 发表周期:12 issues per year 投稿网站: http://ees.elsevier.com/jpras/ 审稿周期:1-3 month 投稿经验总结:主要集中在the latest surgical procedures with audit and outcome studies of new and established techniques in plastic surgery including: cleft lip and palate and other heads and neck surgery, hand surgery, lower limb trauma, burns, skin cancer, breast surgery and aesthetic surgery。每期有1-2篇中国人的文章。 Otolaryngol Head Neck Surg 2010收稿量:318 2010IF:1.565 杂志国家:United States 发表周期:6 issues per year 投稿网站: http://www.editorialmanager.com/otohns/ 审稿周期:1-3 months 投稿经验总结:主要集中在 contemporary, ethical, clinically relevant information in otolaryngology, head and neck surgery (ear, nose, throat, head, and neck disorders)。每期有1-2篇中国人的文章。 Am Surg 2010收稿量:238 2010IF:1.363 杂志国家:United States 发表周期:12 issues per year 投稿网站: http://www.editorialmanager.com/amsurg/ 审稿周期:1-2months 投稿经验总结:主要集中在basic laboratory and clinical investigations。 Appropriate manuscripts on surgical anatomy, surgical history, medical ethics, surgical education, or socioeconomics relevant to surgical practice are considered as well。每期有3-4篇中国人的文章。 J Pediatr Surg 2010收稿量:527 2010IF:1.308 杂志国家:United States 发表周期:12 issues per year 投稿网站: http://ees.elsevier.com/jpedsurg/ 审稿周期:1-2 months 投稿经验总结:主要集中在 the surgical care of infants and children, not only through advances in physiology, pathology and surgical techniques, but also by attention to the unique emotional and physical needs of the young patient。每期有3-4篇中国人的文章。 Ann Plast Surg 2010收稿量:260 2010IF:1.274 杂志国家:United States 发表周期:12 issues per year 投稿网站: http://www.editorialmanager.com/sap/ 审稿周期:2-3months 投稿经验总结:主要集中在all areas of interest to the practicing plastic surgeon。每期有3-4篇中国人的文章。 Surg Today 2010收稿量:209 2010IF:1.057 杂志国家:Japan 发表周期:12 issues per year 投稿网站: http://mc.manuscriptcentral.com/st 审稿周期:1-3months 投稿经验总结:文章来自all fields of surgery, both clinical and experimental。每期有3-4篇中国人的文章。
个人分类: 学术信息|3672 次阅读|0 个评论
Showcase of NLM APIs - Free Webinar
zilu85 2012-3-29 12:07
一个关于PubMed数据库各种API的webinar: Software developers are invited to join NLM data experts as they showcase NLM APIs and provide valuable information on how to find, use, and incorporate medical literature, drug, clinical trial, consumer health information, molecular biology, and other data into novel products. The free webinar, NLM API Showcase: Using NLM APIs for Product Development , will be held April 10, 2012 from 2:00 p.m. - 3:30 p.m. (ET) . 具体内容见如下网址: http://www.nlm.nih.gov/pubs/techbull/ma12/ma12_api_webinar.html
个人分类: 生物医学文本挖掘|3372 次阅读|0 个评论
方法:你所做的工作
热度 1 liwenbianji 2012-2-2 10:44
“方法” 部分应包含足够的信息以供其他研究者准确重复你描述的试验;如果其中有关键信息遗漏,别人就无法完全重复你的实验条件;这会引起结果不一致,有可能造成误会,甚至还会被人指责造假。所以“方法”部分要力求全面。 “ 方法”部分应该使用过去时态,例如:“sections were stained with…” and “data were analyzed using…”。但是在提及图表时应使用现在时,例如:“The patients’ clinical characteristics are listed in Table 1”。 此外,当你在叙述某个事物的定义或当前对它公认的看法时也要用现在时,例如:“the cells were subjected to hypoxia, which induces HIF-1 expression…”。这句话中,虽然实验部分是用的过去时,但由于缺氧(hypoxia) 导致HIF-1是一个普遍现象而不是限定于本文的结果,因此后面半句应该用现在时。 要列出所有试剂的供应商以及设备的厂家;有的期刊还要求列出其地址,即国家、州(如为美国)和市。叙述设备、试剂盒、试剂的时候应该用常用术语来具体描述,不要只用厂商的专门术语或只写型号。比如,不要写成:“Absorbance in each well was measured at a wavelength of 492 nm using a Beckman Coulter AD 340C”,因为大多数人都对Beckman Coulter AD 340C没有任何概念;应该写成:“Absorbance in each well was measured at a wavelength of 492 nm using a multi-well plate reader (AD 340C, Beckman Coulter)”,或者“Absorbance in each well was measured at a wavelength of 492 nm using an AD 340C multi-well plate reader (Beckman Coulter Inc, Fullerton, CA, USA)”。 “方法”部分只能包括最终得出结果的实验方法。如果某个试验失败了或者没能提供你需要的结果,而且你已经决定论文中不提这些结果,那么也没有必要去谈其试验方法。用适当的子标题把各种不同目的的材料和方法分类。如果期刊设有“补充方法 ”(Supplementary Methods)部分,则可用这部分来详述细节,并让纸面刊出的“方法”部分保持简短。新方法应该详细叙述以便他人重复;标准和常用技术只须引用文献即可,但如果你的方法和文献有差异之处应予说明。尤其要保证所有单位都正确,实验条件(如时间、温度)都清楚。最后,如果开展了统计学分析来评价研究结果的意义,则应在“方法”的最后一段叙述你的统计学方法,包括所选择的显著性阈值。 实例 “…homogenates were spun at 10,000 × g and 4 °C for 12 min” 这句话包含了时间、温度两个重要细节。而: “…homogenates were spun at 10,000 × g” 和更简化的 “homogenates were centrifuged” 两个句子中就遗漏这些细节。这些细节有可能对得到你的结果很重要,所以应该给出。 同理,不要只写:“Then, 10 μl of a propidium iodide solution was added to the cells”,因为这对读者毫无意义,除非他们知道该溶液的浓度。应该写成:“Propidium iodide was added to the wells to a final concentration of 0.5 μg/ml”。 下图节选自《The Journal of Clinical Investigation》所发表的一篇论文(doi:10.1172/JCI37155;经同意转载)的方法部分。它显示了“方法”部分的各种要素以及他们如何组合的。 核查清单 1. 用清楚的子标题列出用于不同目的的方法和材料。 2. 研究方法用过去时。 3. 新方法给出充足的细节以便他人重复。 4. 已有方法可用参考文献。 5. 写明厂家/供应商,必要时应提供地址。 6. 说明所采用的统计学方法。 英文原文 Methods: what you did The methods section of your manuscript should contain sufficient information for a capable researcher to accurately repeat the experiments you describe; if essential information is left out, the exact conditions might not be replicated, leading to different results, potential misunderstandings, or worse, accusations of falsification. Thus, the methods section needs to be comprehensive. The methods section should be written in the past tense; for example, “sections were stained with…” and “data were analyzed using…”. An exception to this is references to tables or figures in the manuscript, for example “The patients’ clinical characteristics are listed in Table 1”. Another exception is when providing a definition or describing the current consensus on something: for example, “the cells were subjected to hypoxia, which induces HIF-1 expression…”. Here, although what was done is described in the past tense, the fact that hypoxia induces HIF-1 is described in the present tense because it is a general phenomenon not limited to the present paper. The suppliers of all reagents and the manufacturers of all equipment used should be listed; some journals also request that the locations, that is, city, state (if in the USA) and country, of these companies are provided. When describing equipment, kits, or reagents, you should use familiar terms to define the particular item you are describing, rather than just a manufacturer-specific term or model number. For example rather than writing “Absorbance in each well was measured at a wavelength of 492 nm using a Beckman Coulter AD 340C”, which would be meaningless to the majority of readers, you should write “Absorbance in each well was measured at a wavelength of 492 nm using a multi-well plate reader (AD 340C, Beckman Coulter)” or perhaps “Absorbance in each well was measured at a wavelength of 492 nm using an AD 340C multi-well plate reader (Beckman Coulter Inc, Fullerton, CA, USA)”. Methods should only be included if the results of the described experiments are provided; if an experiment you performed didn’t work, or didn’t provide the results you needed, and you have opted to leave the results out of your paper, then there is no need to describe the associated methods. Use appropriate subheadings to separate materials and methods with different purposes. If available, use a Supplementary Methods section to provide detailed information so that the printed methods section can be kept brief. Novel techniques need to be described in detail so that they can easily be replicated, but established and commonly used techniques can be referenced as long as any variations between the method used in the present study and that described in the cited study are clearly described. Above all, be precise and ensure that all units are correct and all conditions (for example, times and temperatures) are clear. Finally, if any statistical analysis was performed to assess the significance of your data, describe the statistical methods used, including the threshold(s) selected for significance, at the end of the methods section. Examples The sentence “…homogenates were spun at 10,000 × g and 4 °C for 12 min” includes the important details of time and temperature that would have been missing if the author simply wrote “…homogenates were spun at 10,000 × g”, or even more simply “homogenates were centrifuged”. These details could have been essential to obtaining the result you did, and so should be explained. Similarly, rather than saying “Then, 10 μl of a propidium iodide solution was added to the cells”, which is meaningless unless the reader knows the concentration of the propidium iodide solution, you should write “Propidium iodide was added to the wells to a final concentration of 0.5 μg/ml”. The figure below, showing a couple of excerpts from the methods section of paper published in The Journal of Clinical Investigation (doi:10.1172/JCI37155; reproduced with permission), indicates the important components of a methods section and how these fit together. Checklist 1. Clear subheadings for methods/materials with different purposes, with materials described first 2. Methods described in past tense 3. Novel methods described in full detail, sufficient for a capable researcher to reproduce 4. Established methods referenced to previous literature 5. Suppliers/manufacturers provided, including locations if requested 6. Statistical methods described Dr Daniel McGowan 分子神经学博士 理文编辑学术总监
2558 次阅读|1 个评论
[转载]Variations in Three Genes Predict Early Stent Thrombosis
xuxiaxx 2011-10-28 08:49
Variants of three genes related to clopidogrel metabolism and platelet receptor function – CYP2C19, ABCB1, and ITGB3 – appear to be independent risk factors for early stent thrombosis, beyond the already known clinical and angiographic risk factors, according to a report in the Oct. 26 issue of JAMA. A risk-prediction model that incorporated both genetic and clinical data had greater sensitivity and specificity at predicting early stent thrombosis than did a clinical model alone, said Dr. Guillaume Cayla of Institut de Cardiologie, INSERM Unite Mixte de Recherche, Salpetriere Hospital, Paris, and his associates. The researchers assessed all of the 23 genetic variants that have been reported to correlate with clopidogrel pharmacogenetics and arterial thrombosis to determine which ones contribute most to early stent thrombosis. They used a nationwide French registry of patients who had definite stent thrombosis within 30 days of implantation to identify 123 cases, then matched these for age and sex with 246 control subjects who had no stent thrombosis. Peripheral blood samples from these 369 subjects were genotyped for the suspect genetic variations. Only four variations in three genes were found to be significantly associated with early stent thrombosis. First, the CYP2C19 loss-of-function allele occurred in 49% of cases but only 26% of controls. Second, the CYP2C19 gain-of-function allele occurred in only 20% of cases but in 33% of controls. These findings strengthen the current evidence that CYP2C19 plays a predominant role in clopidogrel metabolism, Dr. Cayla and his colleagues said. "The effects of different genes according to different ethnic groups may warrant dedicated studies." Third, an ABCB1 variant occurred in 32% of cases but only 19% of controls. "The ABCB1 gene encodes a drug efflux transporter, P-glycoprotein, that modulates clopidogrel absorption. It has been previously associated with reduced clopidogrel response, but with variable clinical consequences," they noted. And fourth, an ITGB3 variant occurred in only 16% of cases but 28% of controls. The ITGB3 gene encodes for integrin beta-3, "a component of the glycoprotein IIb/IIIa platelet receptor, which mediates the final pathway of platelet aggregation," they said. There was a dose-response relationship in that risk of early stent thrombosis climbed steadily with carriage of an increasing number of these risk alleles, the investigators said. A risk-prediction model that combined genetic data with clinical data had significantly greater power to predict early stent thrombosis than did a clinical model alone. The combined model had 67% sensitivity and 79% specificity in this regard, compared with 60% sensitivity and 70% specificity for the model using only clinical data. "Patients in the highest tertile of risk using the combined clinical and genetic model had a sevenfold increased risk of early stent thrombosis vs. patients in the lowest tertile," Dr. Cayla and his associates said ( JAMA 2011;306:1765-74 ). The researchers also found that two nongenetic factors – loading dose of clopidogrel and the concomitant use of proton pump inhibitors (PPIs) – were significantly related to early stent thrombosis. Cases were much more likely than controls to have received a low loading dose of clopidogrel at stent implantation. And cases also were much more likely than controls to be taking PPIs, which have been suspected of interfering with clopidogrel metabolism. Unlike the genetic risk factors, both clopidogrel dose and PPI use are modifiable risk factors, they noted. This study was limited in that patients with the most severe early stent thrombosis died before they could be included in the study, so the genotype-phenotype relation remains unknown for them. "Stent malappositions or underexpansions are other important factors associated with stent thrombosis that were not evaluated," the investigators said. In addition, the study findings may apply only to white patients because virtually all the subjects, who were drawn from the general population in France, were white. "The effects of different genes according to different ethnic groups may warrant dedicated studies," they added. This study was funded by ACTION, the Société Francaise de Cardiologie, the Fédération Francaise de Cardiologie, and INSERM. The French registry of patients with early stent thrombosis was partially supported by Eli Lilly and the SGAM Foundation. Dr. Cayla and his associates reported ties to numerous industry sources. 来源: http://www.internalmedicinenews.com/news/cardiovascular-disease/single-article/variations-in-three-genes-predict-early-stent-thrombosis/2e03d029e5.html
1287 次阅读|0 个评论
系统理论之预见证实
zhangt10 2010-11-15 21:17
没用等上预期的五年, 这三个月内三个公司三种新药在三个难治病群里的效果-证明了我去年四月那篇文章的正确预见啦。 超级得意中。当然得意啥得保密不能告你。 哈哈。 千万的病患者呀! 哈哈哈。 不枉此生也。。
个人分类: 生活点滴|309 次阅读|1 个评论
systematic reviews Clinical Evidence - May 2010
xupeiyang 2010-5-28 19:58
Welcome to the Clinical Evidence email alert -May 2010 Dear Xu Peiyang , Since the last Clinical Evidence email alert we have updated4 systematic reviews, helping to keep you up to date with the latest evidence across a variety of medical conditions. You can access all the updated systematic reviews and evidence-based articles on the Clinical Evidence website. Kind regards, Dr Rubin Minhas Editor, Clinical Evidence BMJ Evidence Centre Featured update: Colorectal cancer New evidence from one systematic review indicates that preoperative radiotherapy in people with rectal cancer may be more effective than surgery alone at improving survival and recurrence. However, the review found that the improvement in survival was small (estimated increase in survival from 75% to 77% at 5 years and from 60% to 62% at 8 years), and there is evidence for significant late toxicity with preoperative radiotherapy compared with surgery alone. Visit the Clinical Evidence website to see the full review. Other systematic reviews updated this month: Ankle sprain Squamous cell carcinoma of the skin (non-metastatic) Pancreatic cancer To see the full list of updates on all the above conditions visit the Clinical Evidence website. Guest editorial: Application of meta-analysis in systematic reviews At Clinical Evidence , we present an overview of the best available evidence, with a view to answering clinical questions of interest. Frequently, the evidence we identify includes systematic reviews that have meta-analysed data from RCTs. Synthesising data from multiple small RCTs can improve confidence in the effects, or confirm the believed lack of effect, of a particular intervention, thereby accelerating acceptance or rejection of that treatment. However, as Carl Heneghan and Rafael Perera outline in their Editorial, producing a reliable meta-analysis may not always be as simple as combining all the RCTs for the treatment of interest. To read the full editorial click here . 12-step guide to a primary care systems approach for smoking cessation: FREE Featured Clinical Evidence resource In addition to up-to-date systematic reviews, the Clinical Evidence website also contains a range of resources and tools to help you practice evidence based medicine. Why not take a look at our report on smoking cessation , which includes a 12-step guide to a primary care systems approach for smoking cessation on Page 38? Click here to access the report. Register for your Clinical Evidence alerts If you have been forwarded this email and would like to receive the Clinical Evidence monthly alert, please register here. If Clinical Evidence has made a significant difference to your clinical practice, or if you have any other feedback about this alert, then please feel free to email us with yourcomments . About BMJ Group Privacy policy Terms and conditions Contact us The BMJ Group is one of the world's most trusted providers of medical information for doctors, researchers, health care workers and patients. The recipient should check this email and attachments for viruses because the BMJ Group accepts no liability for any damage caused by viruses. Emails sent or received by the BMJ Group may be monitored for size, traffic, distribution and content. Use of our content is governed by our website terms and conditions http://group.bmj.com/group/about/legal/terms . BMJ Publishing Group Limited trading as BMJ Group. A private limited company, registered in England and Wales under registration number 03102371. Registered office: BMA House, Tavistock Square, London WC1H 9JR, UK. To stop receiving these emails, unsubscribe here . Your unsubscribe request may take up to five working days to process.
个人分类: 循证医学|1563 次阅读|0 个评论
医学证据 Clinical Evidence 2010年5月1日 00:17 (星期六)
xupeiyang 2010-5-2 11:25
Conditions User guides Free trial Welcome to the Clinical Evidence email alert -April 2010 Dear Xu Peiyang , Since the last Clinical Evidence email alert we have updated12 systematic reviews, helping to keep you up to date with the latest evidence across a variety of medical conditions. You can access all the updated systematic reviews and evidence-based articles on the Clinical Evidence website. Kind regards, Dr Rubin Minhas Editor, Clinical Evidence BMJ Evidence Centre Featured update: Stroke: secondary prevention Are vitamin B supplements (including folate) effective at preventing stroke? Vitamins B6 and B12 and folic acid are known to lower homocysteine levels, and observational studies have shown that low homocysteine levels are associated with low rates of stroke. However, new information from two systematic reviews and one RCT indicates that vitamin B supplements are no more effective than placebo at stroke prevention in people with a history of cardiovascular disease. Visit the Clinical Evidence website to see the full review. Other systematic reviews updated this month: Chlamydia (uncomplicated, genital) Stroke management Uveitis (acute anterior) Dementia Impacted wisdom teeth Constipation in children Basal cell carcinoma Constipation in people prescribed opioids Anal fissure (chronic) Carpal tunnel syndrome Altitude sickness To see the full list of updates on all the above conditions visit the Clinical Evidence website. Guest editorial: Could early intervention be the key in preventing dementia? Limiting the financial and personal cost of dementia are key goals for healthcare systems. One strategy that has recently gained momentum is early intervention to prevent development of the disorder. Obesity, high cholesterol, and high blood pressure have been suggested as risk factors for developing dementia. As Tom Russ and John Starr consider in their Editorial, evidence suggests that taking steps in middle age to tackle these areas could reduce an individual's risk of developing dementia by as much as 20%. To read the full editorial click here . Calculating risk: FREE Featured Clinical Evidence resource In addition to up-to-date systematic reviews, the Clinical Evidence website also contains a range of resources and tools to help you practice evidence-based medicine. Why not try our featured resource this month, how to calculate risk? Click here to use the How to calculate risk resource.
个人分类: 热点前沿|1672 次阅读|0 个评论
[转载] 医学证据本月更新 Clinical Evidence Read this month's featured updates
xupeiyang 2010-4-1 08:08
Dear Xu Peiyang , Since the last Clinical Evidence email alert we have updated4 systematic reviews, helping to keep you up to date with the latest evidence across a variety of medical conditions. You can access all the updated systematic reviews and evidence-based articles on the Clinical Evidence website. Kind regards, Dr Rubin Minhas Editor, Clinical Evidence BMJ Evidence Centre Heart failure: Featured update Should angiotensin II receptor blockers be used for diastolic heart failure? Evidence from two RCTs in over 7,000 people with diastolic heart failure suggest that angiotensin II receptor blockers (candesartan and irbesartan) do not significantly reduce mortality compared with placebo, but their effects on hospital readmission are unclear. To read this review click here Menopausal symptoms: Featured update New evidence from one RCT has found that tibolone is associated with breast cancer recurrence in women previously treated surgically for breast cancer. The RCT found that, at a median follow-up time of just over 3 years, breast cancer recurrence was significantly higher with tibolone compared with placebo. Visit the Clinical Evidence website to see the full review Other systematic reviews updated this month: Bacterial conjunctivitis Intimate partner violence towards women To see the full list of updates on all the above conditions visit the Clinical Evidence website. Guest editorial: Clopidogrel and proton pump inhibitors: a spotlight ondrug-drug interactions When recommending one pharmacological treatment, a prescriber may be confident of the quality of the evidence on the effectiveness/harms of that chosen drug. But can the same be said when prescribing more than one drug? What if one drug interacts with another? Using the potential interaction between clopidogrel and PPIs as an example, this editorial considers the current situation and highlights possible obstacles to developing an evidence base on drug-drug interactions. To read the full editorial click here
个人分类: 循证医学|1505 次阅读|0 个评论
[转载]Special Drug Information Association Conference on Clinical Development of
xupeiyang 2010-3-9 07:54
Make sure dia@diahome.org is in your address book. Conferences Meetings | Exhibits Advertising | Training | Online Learning | Membership | Get Involved Register by March 22 and Save $100 with Your Exclusive Members-only Discount! Clinical Development of Stem Cell Therapies: Scientific, Regulatory and Ethical Considerations April 12-13 | Bethesda North Marriott Hotel Conference Center | North Bethesda, MD Join expert leadership from industry, academia, and regulatory agencies to strategize and analyze the transitional process from discovery and regulatory approval to the therapeutic use of stem cell products. FEATURED TOPICS: Case studies related to the pre-clinical, CMC, and clinical stages of development for stem cell products FDA and EMEA experience with stem cell clinical development NIH guidelines Examples of stem cells in preclinical and clinical development Immunosuppression strategies Analysis of CMC issues around reagents, devices, and potency Register Online | Flyer Program Tabletop Exhibit Opportunities Showcase your company's products/services to key decision makers. Contact Jeff.Korn@diahome.org for more information. Contact Information Marjorie Davis Phone: 215.442.6176 Marjorie.Davis@diahome.org Conference developed by the DIA Biotechnology Innovative Preclinical Sciences Special Interest Area Community (SIAC). Other Events of Interest: 46th Annual Meeting June 13-17 | Washington, DC Forward to a Friend Join us on Facebook Join us on LinkedIn Follow us on Twitter
个人分类: 药学研究|2171 次阅读|0 个评论
[转载]最新医学证据 Clinical Evidence and Best Practice Read this months updates
xupeiyang 2010-2-25 08:28
Don't miss out on this month's Clinical Evidence alert... view here Subscribe Conditions User guides Free trial Welcome to the Clinical Evidence email alert - February 2010 Dear Xu Peiyang , The Clinical Evidence alert is your monthly email service that brings you up-to-date with all the latest research evidence across a variety of medical conditions. Clinical research is essential in the delivery of quality health care, and this month, Clinical Evidence brings you all the new and updated systematic reviews and evidence-based research articles that have been published on the website throughout February to help you make better, more informed health care decisions. Plus, take a look at this month's guest editorial and get an update on Differential Diagnosis - the BMJ Groups new iPhone app. Kind regards, Dr Rubin Minhas Editor, Clinical Evidence BMJ Evidence Centre Updated systematic reviews Prevention of CVD: treating hypertension New evidence found Obesity in adults New evidence found and option added Urinary tract infection in children New evidence found Cluster headache New evidence found and option added Thromboembolism New evidence found Colic in infants New evidence found Hepatitis C (chronic) New evidence found Post-traumatic stress disorder New evidence found Fracture prevention in postmenopausal women New evidence found and option added To see the full list of updates on all the above conditions visit the Clinical Evidence website Guest editorial This month's editorial: Artemisinin-based combination therapy for malaria, but which one? Interpreting trial results to determine which malaria treatment to recommend is difficult, and this presents a challenge to health policy makers. Conventional meta-analyses are of limited help owing to malaria's unique epidemiology - resistance to new drugs is rapid and the effectiveness of treatments varies across the world. However, in this editorial, David Sinclair, Piero Olliaro, and Paul Garner discuss new and innovative ways of looking at systematic review data that may overcome these difficulties, and make decisions clearer. To read the full editorial click here Other news from the BMJ Group: NEW: Differential Diagnosis iPhone app from the BMJ Group The Differential Diagnosis iPhone app provides healthcare professionals with trustworthy mobile decision-support information from Clinical Evidence and Best Practice . It guides you through history, exam, first tests to order and other tests to consider for over 10,000 differential diagnoses. Since launch, on the 1st January, this app has remained withinin the top 3 in the paid medical apps chart! For more information visit the medical section of the iTunes app store or find out more at http://bestpractice.bmj.com/differentials New features on Best Practice A number of new enhancements have been added to the Best Practice website. Here is a summary of what you can now do on Best Practice : Set up your own RSS feeds to keep up-to-date with any updates that have been made to topics in Best Practice Sign up to receive monthly Best Practice email alerts containing all the latest content updates and new developments Recommend Best Practice to your friends colleagues Get easier access to patient information leaflets For more details about the above enhancements and to see more new features that have been added to Best Practice , please click here Forward this email on to your colleagues If you have been forwarded this email and would like to receive the Clinical Evidence monthly alert, please register here. If Clinical Evidence has made a significant difference to your clinical practice, or if you have any other feedback about this alert, then please feel free to email us with yourcomments . About BMJ Group Privacy policy Terms and conditions Contact us The BMJ Group is one of the world's most trusted providers of medical information for doctors, researchers, health care workers and patients. The recipient should check this email and attachments for viruses because the BMJ Group accepts no liability for any damage caused by viruses. Emails sent or received by the BMJ Group may be monitored for size, traffic, distribution and content. Use of our content is governed by our website terms and conditions http://group.bmj.com/group/about/legal/terms . BMJ Publishing Group Limited trading as BMJ Group. A private limited company, registered in England and Wales under registration number 03102371. Registered office: BMA House, Tavistock Square, London WC1H 9JR, UK. To stop receiving these emails, unsubscribe here . Your unsubscribe request may take up to five working days to process.
个人分类: 循证医学|1569 次阅读|0 个评论
[转载]Clinical Pharmacology and Therapeutics - Table of Contents alert Volume 87 I
xupeiyang 2010-1-30 07:41
TABLE OF CONTENTS Volume 87, Issue 2 (February 2010) In this issue In This Issue Editorial News Views Perspectives State of the Art Research Discovery Development Regulation Use Also new AOP Advertisement SCIENCE, STRATEGY AND LEADERSHIP. WELCOME TO TRANSLATIONAL MEDICINE IN BIOPHARMACEUTICALS. Director/Senior Director, Translational Pharmacology Discovery Medicine. Physician Roles in Biopharmaceutical RD based in UK (Stevenage) and US (Philadelphia). For more details on these roles visit http://www.gsk.com/careers/ search for Req ID 57200 or 57201 . Sign up for e-alerts Recommend to your library Web feed Subscribe Advertisement Now on clinpharmpod : Nutraceuticals Join us on clinpharmpod as we discuss topics related to the dietary supplement field. This podcast addresses the role clinical pharmacology plays in advancing the safety and efficacy of dietary supplements and the FDA's experience in the first year after implementation of the Dietary Supplement of Nonprescription Drug Consumer Protection Act. Clinpharmpod : Download and discover. In This Issue Top IN THIS ISSUE Clin Pharmacol Ther 2010 87: 135; 10.1038/clpt.2009.288 Abstract | Full Text Editorial Top EDITORIAL Nutraceuticals: Has There Been Any Progress? C AHaller Clin Pharmacol Ther 2010 87: 137-141; 10.1038/clpt.2009.250 Abstract | Full Text News Views Top HIGHLIGHTS Clin Pharmacol Ther 2010 87: 142-143; 10.1038/clpt.2009.289 Abstract | Full Text ASCPT NEWS Clin Pharmacol Ther 2010 87: 144-145; 10.1038/clpt.2009.264 Abstract | Full Text Perspectives Top POINT/COUNTERPOINT Why Change Is Needed in Research Examining Dietary Supplements CTsourounis and SBent Clin Pharmacol Ther 2010 87: 147-149; 10.1038/clpt.2009.241 Abstract | Full Text Successful Botanical Research Requires Botanical Expertise S JDentali Clin Pharmacol Ther 2010 87: 149-151; 10.1038/clpt.2009.280 Abstract | Full Text COMMENTARIES Medicines Regulation and Health Technology Assessment ABreckenridge, KWoods and TWalley Clin Pharmacol Ther 2010 87: 152-154; 10.1038/clpt.2009.261 Abstract | Full Text Use of Complementary and Alternative Therapies in Children A DWoolf and PGardiner Clin Pharmacol Ther 2010 87: 155-157; 10.1038/clpt.2009.224 Abstract | Full Text Assessing the Safety and Comparative Effectiveness of Follow-On Biologics (Biosimilars) in the United States SHennessy, C ELeonard and RPlatt Clin Pharmacol Ther 2010 87: 157-159; 10.1038/clpt.2009.249 Abstract | Full Text Intermittent Preventive Therapy for Malaria in Pregnancy: Is SulfadoxinePyrimethamine the Right Drug? SParikh and P JRosenthal Clin Pharmacol Ther 2010 87: 160-162; 10.1038/clpt.2009.284 Abstract | Full Text CONFERENCE PROCEEDINGS From Adverse Drug Reactions to Drug Disposition to WHO and Essential Medicines to Our Discipline of Clinical Pharmacology M MReidenberg Clin Pharmacol Ther 2010 87: 163-165; 10.1038/clpt.2009.49 Abstract | Full Text State of the Art Top STATE OF THE ART Evaluation and Management of Cardiac Safety Using the Electrocardiogram in Oncology Clinical Trials: Focus on Cardiac Repolarization (QTc Interval) JMorganroth, R RShah and J WScott Clin Pharmacol Ther 2010 87: 166-174; advance online publication, December 9, 2009; 10.1038/clpt.2009.214 Abstract | Full Text A Comprehensive Approach to Identifying and Authenticating Botanical Products T JSmillie and I AKhan Clin Pharmacol Ther 2010 87: 175-186; advance online publication, December 23, 2009; 10.1038/clpt.2009.287 Abstract | Full Text Research Top REPORTS First-in-Human Study Demonstrating Pharmacological Activation of Heme Oxygenase-1 in Humans A EBharucha, AKulkarni, K MChoi, MCamilleri, MLempke, G JBrunn, S JGibbons, A RZinsmeister and GFarrugia Clin Pharmacol Ther 2010 87: 187-190; advance online publication, December 2, 2009; 10.1038/clpt.2009.221 Abstract | Full Text ARTICLES Effect of Simultaneous Induction and Inhibition of CYP3A by St John's Wort and Ritonavir on CYP3A Activity VHafner, MJger, A-KMatthe, RDing, JBurhenne, W EHaefeli and GMikus Clin Pharmacol Ther 2010 87: 191-196; advance online publication, November 18, 2009; 10.1038/clpt.2009.206 Abstract | Full Text Clinical Pharmacokinetics of the BCRABL Tyrosine Kinase Inhibitor Nilotinib CTanaka, O Q PYin, VSethuraman, TSmith, XWang, KGrouss, HKantarjian, FGiles, O GOttmann, LGalitz and HSchran Clin Pharmacol Ther 2010 87: 197-203; advance online publication, November 18, 2009; 10.1038/clpt.2009.208 Abstract | Full Text Selective Antagonism of Opioid-Induced Ventilatory Depression by an Ampakine Molecule in Humans Without Loss of Opioid Analgesia B GOertel, LFelden, P VTran, M HBradshaw, M SAngst, HSchmidt, SJohnson, J JGreer, GGeisslinger, M AVarney and JLtsch Clin Pharmacol Ther 2010 87: 204-211; advance online publication, November 11, 2009; 10.1038/clpt.2009.194 Abstract | Full Text Delays in New Drug Applications in Japan and Industrial RD Strategies YHirai, HKinoshita, MKusama, KYasuda, YSugiyama and SOno Clin Pharmacol Ther 2010 87: 212-218; advance online publication, November 25, 2009; 10.1038/clpt.2009.215 Abstract | Full Text Pharmacokinetics of 23-Epi-26-Deoxyactein in Women After Oral Administration of a Standardized Extract of Black Cohosh R Bvan Breemen, WLiang, SBanuvar, L PShulman, YPang, YTao, DNikolic, K MKrock, D SFabricant, S-NChen, SHedayat, J LBolton, G FPauli, C EPiersen, E CKrause, S EGeller and N RFarnsworth Clin Pharmacol Ther 2010 87: 219-225; advance online publication, December 23, 2009; 10.1038/clpt.2009.251 Abstract | Full Text Pharmacokinetics of Sulfadoxine and Pyrimethamine in Intermittent Preventive Treatment of Malaria in Pregnancy M MNyunt, IAdam, KKayentao, Jvan Dijk, PThuma, KMauff, FLittle, YCassam, EGuirou, BTraore, ODoumbo, DSullivan, PSmith and K IBarnes Clin Pharmacol Ther 2010 87: 226-234; advance online publication, September 23, 2009; 10.1038/clpt.2009.177 Abstract | Full Text Discovery Development Top TRANSLATIONAL MEDICINE Clinical Pharmacology and Dietary Supplements: An Evolving Relationship B JGurley Clin Pharmacol Ther 2010 87: 235-238; advance online publication, November 25, 2009; 10.1038/clpt.2009.245 Abstract | Full Text Regulation Use Top PRACTICE FDA Regulation of Dietary Supplements and Requirements Regarding Adverse Event Reporting V HFrankos, D AStreet and R KO'Neill Clin Pharmacol Ther 2010 87: 239-244; advance online publication, December 23, 2009; 10.1038/clpt.2009.263 Abstract | Full Text
个人分类: 药学研究|2376 次阅读|0 个评论
Clinical Laboratory International ; Managed Care 2010年1月9日(星期六) 08:00
xupeiyang 2010-1-9 08:16
Request your Complimentary Technical Documents! Hi xu, Given your interest in previous offers in the past, I wanted to personally extend this opportunity to apply for a free subscription to these publications. Enjoy! Vianna Account Manager Clinical Laboratory International Each issue contains specially commissioned mini-review articles written by eminent scientists or clinicians on hot topics carefully chosen to be of special interest to pathologists, clinical biologists and clinical lab management. The articles go into the principles, diagnostic significance, practice and applications of the latest technological advances. Managed Care Published monthly, it delivers high-interest articles and features through original research and writing. A strict fact-checking and peer-review process assures the accuracy and relevance of editorial content. It serves Managed Care Organization executives and administrators, primary care and group practice physicians (GP, FP, IM, DO) whose practices are managed care, HMO staff physicians and others allied to the field. MORE Trade Publications Complimentary to Qualified Professionals include: Lab Manager Magazine Helps provide a forum and a framework to help lab professionals hire and supervise staff, establish a laboratory, and plan a coherent research program, while keeping the goals of good science and scientific discovery at the forefront. International Hospital Equipment Solutions Is the leading international magazine for healthcare decision makers. P T Is a monthly Journal for Pharmacy and Therapeutics decision makers. Other Professional Publications can be found at: Healthcare , more ...
个人分类: 信息检索|1519 次阅读|0 个评论
The lack of transparency of clinical trials on endometriosis
swguo 2009-3-5 22:38
The lack of public disclosure of results from clinical trials is used to be a hallmark of clinical trials worldwide. In the last five years, this situation is beginning to change following the announcement of the International Committee of Medical Journal Editors (ICMJE) in 2004 that its journals would not publish the results of any clinical trial that had not been appropriately registered at ClinicalTrials.gov or other qualified public registry by 13 September 2005. Some other international institutions like the WHO also followed the suit, demanding for more openness of clinical trials. Endometriosis is a common and debilitating gynecological condition with an enigmatic pathogenesis. The condition is so common that there is a good chance that someone you are related with or know of has the condition. Due to the high recurrence risk post surgery, medical treatment is often needed. The current medical treatment modalities for endometriosis, however, are only marginally effective in relieving endometriosis-associated pain, often with relatively short-term effect. In addition, they have many undesirable, and sometimes severe, side effects, which may prohibit the long-term management that is needed for endometriosis. Consequently, more efficacious therapeutics, preferably with improved safety and cost profiles, are sorely needed. In response to this need , there have been numerous reports in the last decade of positive animal and in vitro results of various compounds as potential therapeutics for endometriosis. A handful of these have undergone phase II/III clinical trials. As of writing, 62 endometriosis-related clinical trials have been registered at ClinicalTrials.gov. Among them, 29 are listed as completed, and 2 as suspended. Excluding those non-interventional studies and phase I or IV trials, there are 16 completed phase II/III trials, which evaluated the efficacy of various promising compoundsat least pre-clinically. Yet so far only 3 of the 16 trials (18.8%) have published their results, and the remaining 13 (81.2%) studies have not. If we also count a phase II clinical trial that was launched with great fanfare in 1999 yet nothinghas beenreported ever since, there are only 3 out of 17 trials (17.6%) that have published their results. A great majority (82.4%) of clinical trials have not published their results. Although the lack of transparency is not uniquely restricted to endometriosis, its negative impact on endometriosis research may nonetheless be disproportionately high, since fewer trials are conducted for this disease as compared with other less prevalent but more serious diseases (like cancer) or common chronic disorders like rheumatoid arthritis. Recognizing the potential negative impact of this lack of transparency on endometriosis research, I drafted a manuscript calling for more transparency and solicited some fellow scientists to co-author it. We argued that this lack of transparency will not benefit trial sponsors nor the public, and will ultimately prove detrimental to research efforts attempting to develop more efficacious and safer therapeutics for endometriosis. Indeed, the very purpose of mandatory registration is to make results of clinical trials public knowledge, including the good (efficacy) and the bad (lack of efficacy and/or adverse effects) results, so that everyone will benefit from hard-earned lessons so that positive results are built upon scientifically, and so that no one repeats others mistakes and miscalculations. Unless there is complete transparency some invaluable insight would be forever lost, along with their investment, to the detriment of the cause to uncover better therapeutics for endometriosis and other conditions . The manuscript is published in a recent issue of Human Reproduction (http://humrep.oxfordjournals.org/cgi/content/full/dep045?ijkey=FXCBczXwo3BfQKNkeytype=ref). So we are sticking our necks out for what we believe a just cause. Hopefully, oureffort will make a difference of this deplorable situation (http://www.medicalnewstoday.com/articles/141066.php).
个人分类: 未分类|4579 次阅读|0 个评论

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