罗氏共招募了431位患有中轻度阿尔兹海默病的患者参加此次临床II期研究,并对其进行随机、双盲、安慰剂对照试验。结果发现,Crenezumab没有达到预期目标。
但报告指出,给轻度阿尔兹海默病患者注入高剂量Crenezumab之后能大幅度减缓阿尔兹海默病的认知退化程度,不过需要进一步数据确认。
Crenezumab是一种实验性全人源化单抗,作用于所有β-淀粉样蛋白。目前由罗氏旗下的基因泰克(Genetech)公司负责研发。
据国际阿兹海默症协会数据统计,现在全球范围内共有4400万位阿尔兹海默病患者。患者数量到2050年将会再翻三倍。而在2002年至2012年间,99.6%的阿尔兹海默病药物临床试验都惨遭失败。
7、对院外临床研究助理(CRC)的几点思考
发布日期:2014-07-17 来源:中山大学附属肿瘤医院 作者:曹烨 洪明晃就目前来看,中国的SMO最主要业务就是可为研究机构提供大量经过培训的CRC。当然,在如泡沫般迅速涨大的行业里,“有资质,训练有素”的CRC在一夜之间就批量供应是让行内人都感到意外和担心的。因此最让机构惴惴不安的就是如何招架这来势凶猛的潮流,为医院守住质量关,为研究者把好用人关。
第一,医院可以接受院外CRC吗?似乎这已不能成为一个容许质疑的问题。如果不接受,限于公立医院相对严苛的人事聘用制度,医院找不到更好的解决措施。那欧美国家为何不用院外CRC?根据笔者在哈佛医学院肿瘤中心等2年多的进修经历、考察:首先,人事聘用灵活,只要研究科室/PI有经费,就可向社会公开招聘CRC。其次,国外有大量自由职业、大学院校毕业生以及愿意专注从事CRC的择业者;凡是希望从事医药相关行业,准备报读医学院的college student,会把从事CRC工作1-2年作为了解医疗行业最好的一个途径和窗口,通过1-2年工作,熟悉了临床研究的基本操作,认识了相关领域的知名教授,为获得教授推荐信和进一步确定专业方向奠定基础。因此,在美国招聘CRC是个僧多粥少的局面,研究科室虽谈不上“百里挑一”,但绝对有充足的候选者可以备选。另外,美国不使用外聘CRC还有一个重要原因,那就是保护医院以及受试者的隐私。如果CRC来自第三方机构,是无权查看医疗记录,以及接触医疗文件的。
第二,院外CRC应当有所为,有所不为。CRC的教育背景多种多样,有临床医疗专业、药剂专业、护理专业、甚至非医药专业等,因此应把握如下原则:1. 非职业技术资格允许范围内的不可为;2. 非授权范围内的不可为。主要研究者应在授权时充分考虑CRC的身份以及专业、执业背景,避免授错权,用错人;机构也应该制定相关工作指引来规范院外CRC在医院的工作与行为,做好人员的登记备案,统一发放工作证,避免外聘人员到病区工作处于无人知晓、无人监管和如入无人之境的“三无”状态。对医院来说,院外CRC毕竟属于外援,绝对不要“喧宾夺主”。
第三,外聘CRC应由谁来聘?目前国内对院外CRC的管理有几种模式,我们机构去年底以来坚持采取“三方两议”,即:申办者/CRO,研究机构/研究者和SMO三方,申办者与研究机构,研究机构与SMO分别签署两份聘用协议。我们认为,从回避利益冲突,保证研究质量监管以及明确责权利的角度,三方两议是比较易行和合理的模式。
第四,当SMO与研究机构的SOP不一致时,应该听谁的?应该说,无论是SMO还是机构的SOP,其制定的初衷都是为了确保研究的科学性和伦理性,保证方案实施的质量和规范。因此,当双方出于各自立场制定的SOP发生不一致时,我们认为应该把握如下标准:1. 不违背国家相关法规、政策;2. 不违背研究方案、协议;3. 不违背所在研究场地的制度及SOP。
在我国,SMO较之CRO的出现较迟,但可以预见,随着国家对临床研究领域投入的关注越来越多,机构管理水平越来越高,CRC行业的规范一定比CRA行业来得更快,更加系统。
(作者:曹烨 中山大学附属肿瘤医院药物临床试验机构办公室主任
洪明晃 中山大学附属肿瘤医院药物临床试验机构主任,广东省药学会药物临床试验专业委员会主任委员)
Issued: Wednesday 16 July 2014, London UK & South San Francisco, CA, USA - LSE Announcement
GlaxoSmithKline plc (LSE/NYSE: GSK) and Theravance, Inc. (NASDAQ: THRX) today announced the start of a global phase III study, known as IMPACT, to evaluate the efficacy and safety of the ‘closed’ triple combination of FF/UMEC/VI in patients with chronic obstructive pulmonary disease (COPD). IMPACT is the first pivotal phase III study in a programme to evaluate a once-daily closed triple combination treatment of an inhaled corticosteroid (ICS); a long-acting muscarinic antagonist (LAMA); and a long-acting beta2-adrenergic agonist (LABA) in patients with COPD.
The IMPACT study will enrol approximately 10,000 patients and assess whether the combination of FF (fluticasone furoate, an ICS), UMEC (umeclidinium, a LAMA) and VI (vilanterol, a LABA), all delivered in GSK’s Ellipta inhaler, can reduce the annual rate of moderate and severe exacerbations compared with two approved once daily COPD treatments, Relvar/Breo Ellipta (FF/VI), which is an ICS/LABA combination, and Anoro Ellipta (UMEC/VI), which is a LAMA/LABA combination.
Dave Allen, Head, GSK Respiratory Therapy Area Unit, R&D, said: “When developing our respiratory portfolio we recognised the need to offer a range of molecules that could be co-formulated in different combinations to meet the needs of individual patients. We know from the scientific literature and prescribing data that there are already COPD patients who receive three medicines in different inhalers, for whom a once-daily treatment in a single ‘closed’ device could be valuable. The IMPACT study will be important in advancing our understanding of how the combination of FF/UMEC/VI could be used in this setting when compared to dual combination therapy options.”
Rick E Winningham, Chief Executive Officer of Theravance, said: “The start of the IMPACT study marks a significant milestone in our development programme with GSK and we are excited about the potential opportunity for a triple combination treatment approach. This phase III programme has the potential to demonstrate the safety and efficacy profile of a new and important therapy that could deliver additional benefits and convenience to the growing number of adults living with COPD worldwide.”
about the IMPACT study
IMPACT (InforMing the PAthway of COPD Treatment) is a double-blind, three-arm, parallel group study enrolling a total of 10,000 patients across 38 countries. Eligible patients will be randomised to receive either FF/UMEC/VI 100/62.5/25mcg, FF/VI 100/25mcg or UMEC/VI 62.5/25mcg once-daily for a period of 52 weeks.
The co-primary endpoints of the study are: the annual rate of moderate and severe exacerbations comparing FF/UMEC/VI with FF/VI; and the annual rate of moderate and severe exacerbations comparing FF/UMEC/VI with UMEC/VI. Key secondary endpoints include baseline changes in lung function (trough FEV1) comparing FF/UMEC/VI and FF/VI; time to first moderate or severe exacerbation in all three arms of the study; and the annual rate of severe exacerbations in all three arms of the study.
about COPD
Chronic obstructive pulmonary disease is a disease of the lungs that includes chronic bronchitis, emphysema or both. COPD is characterised by obstruction to airflow that interferes with normal breathing.
Long-term exposure to lung irritants that damage the lungs and the airways are usually the cause of COPD1. Cigarette smoke, breathing in second-hand smoke, air pollution, chemical fumes or dust from the environment or workplace can all contribute to COPD1. Most people who have COPD are at least 40 years old when symptoms begin.
about Relvar®/Breo® Ellipta® (fluticasone furoate + vilanterol)
Relvar/Breo Ellipta is a once-daily dual combination treatment comprising fluticasone furoate, an inhaled corticosteroid and vilanterol, a long-acting beta2-agonist, in a single inhaler, the Ellipta®. Full US prescribing information, including BOXED WARNING and Medication Guide is available at us.gsk.com or US Prescribing Information for Breo Ellipta.
about Anoro® Ellipta® (umeclidinium + vilanterol)
Anoro Ellipta is a once-daily combination treatment comprising two bronchodilators: umeclidinium, a long-acting muscarinic antagonist, and vilanterol, a long-acting beta2agonist, in a single inhaler, the Ellipta®. Full US prescribing information, including BOXED WARNING and Medication Guide is available at:http://us.gsk.com/products/assets/us_anoro_ellipta.pdf.
RELVAR®, BREO®, ANORO® and ELLIPTA® are trademarks of the GlaxoSmithKline group of companies.
GSK – one of the world’s leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For further information please visit www.gsk.com.
Theravance, Inc., A Royalty Management Company – is focused on maximizing the potential value of the respiratory assets partnered with Glaxo Group Limited (GSK), including RELVAR®/BREO® ELLIPTA® and ANORO® ELLIPTA®, with the intention of providing capital returns to stockholders. Under the Long-Acting Beta2Agonist (LABA) Collaboration Agreement with GSK, Theravance is eligible to receive the associated royalty revenues from RELVAR®/BREO® ELLIPTA® (fluticasone furoate/vilanterol, “FF/VI”), ANORO® ELLIPTA® (umeclidinium bromide/vilanterol, “UMEC/VI”) and if approved and commercialized, VI monotherapy. Theravance is also entitled to a 15% economic interest in any future payments made by GSK relating to the combination of UMEC/VI/FF and the Bifunctional Muscarinic Antagonist-Beta2Agonist (MABA) program, as monotherapy and in combination with other therapeutically active components, such as an inhaled corticosteroid, and any other product or combination of products that may be discovered and developed in the future under its LABA Collaboration Agreement with GSK (other than RELVAR®/BREO®ELLIPTA®, ANORO® ELLIPTA® and VI monotherapy). For more information, please visit Theravance’s web site at www.thrxinc.com.
sunice119 发表于 2014-7-18 09:12 AM
好东东,有中文也有英文,赞一个!楼主辛苦了!
小提一下:
新闻1和2 重复了。
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