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专访:吴龑:真实世界研究的意义、价值、壁垒

2016-12-14 吴䶮 MedSci原创

梅斯医学就真实世界研究的意义、价值和壁垒问题采访了和记黄埔医药(上海)有限公司临床及注册部的执行总监吴龚。

导语:在欧州和美国,对于一项新上市的医疗产品,特别是医药产品,生产厂家必须证明其与市场上现有类似诊治手段相比较后,所显示出的在经济效益上的优势,才能被医疗保险机构和各医疗服务机构接受并广泛使用。

近几年,除经济效益之外,在非干预的情况下,也就是说在“真实世界”里,反映的临床效果以及患者反馈信息,也已经成为“实效证据”的一部分,影响着一个医疗手段是否能被广泛接纳,是否能有“市场渗入”。这包含了临床效果、患者回馈、经济效益3个方面的评估,在欧美和其他一些国家被称为“医疗技术评估”,该类评估目前正被各医疗机构广泛使用,用来提高医疗诊治质量。

梅斯医学就真实世界研究的意义、价值和壁垒问题采访了和记黄埔医药(上海)有限公司临床及注册部的执行总监吴龑。



吴龑先生现任和记黄埔医药公司执行总监,负责公司的临床研发。在过去二十多年,他曾经在多家跨国公司管理临床研发,包括在瑞典阿斯特拉公司(现阿斯利康)担任项目经理,在美国昆泰公司担任临床研究经理,在德国勃林格殷格翰公司担任临床研究负责人,在美国百健公司担任医学和临床总监,在日本第一三共制药任职医药开发总经理。他曾经担任若干个大型国际临床试验的项目负责人,并任全球策划委员会委员。曾经领导和建立了跨国医药公司在亚洲的研发中心。

吴龑先生毕业于上海交通大学医学院获医学学士学位,之后师从王振义和徐也鲁教授进行血液的病理生理研究获医学硕士学位。在国内外大量临床研究专题会议担任主持和讲者,有丰富的GCP稽查和培训经验。

梅斯医学:和记黄埔医药已有数个极具潜力的候选药物进入到不同的临床阶段,包括自身免疫性疾病候选药物,今年和记黄埔有在研发中的药物有哪些临床阶段的进展?

吴龑:和记黄埔医药成立于2002年9月。在过去的15年里,和记黄埔医药专注于为全球病患研发治疗癌症和自身免疫性疾病的创新药物,打造世界一流的新药研发企业,已拥有国内最丰富的产品管线。其7大临床候选化合物目前正在北美、欧洲、澳大利亚及大中华区广泛开展临床研究,这其中包括了4项III期中国注册临床试验,以及1项将于2017年初启动的全球多中心的III期注册试验。今年呋喹替尼结直肠癌III期临床接近尾声而其III期肺癌的临床正在全面推进。索凡替尼的神经内分泌肿瘤III期临床试验也已在全国推进。

以下是梅斯医学就䶮总监对药物研究临床阶段的总结:



梅斯医学:真实世界研究这种新理念有什么意义?

吴龑:真实世界研究是新药上市以后最有意义的事情。研究以大数据为基础,通过深入挖掘数据,对临床药物、方法等进行再评价。如:阿司匹林,原来是解热镇痛药,后来通过临床数据发现可以抗血小板而预防血栓栓塞, 进而又发现它可以预防结直肠癌。研究以完整的观察性队列、登记和管理型数据库,生产厂家能将其与市场上现有类似诊治手段相比较后,总结其在疾病治疗上的优势,最终被医疗保险机构和各医疗服务机构接受并广泛使用。

真实世界研究贴近临床实践,在安全性和经济性方面的评价有天然优势。RCT是评价药物或者治疗措施的金标准,而RWE是RCT的有益、重要补充,除了评价药物疗效,更多的是整个临床实践对患者的疗效,其使临床研究回归临床真实世界,解决临床问题,与医疗市场、国家政策(如医保)结合可能更为紧密。

梅斯医学:真实世界研究受到越来越多医学研究人员的关注,真实世界研究有哪些价值?

吴龑:真实世界研究的价值可以从以下三个方面看:

从患者角度看,可以基于自己的病情在现有的药品中优中选优并且有利于充分了解新药的安全性和有效性。

从研究者角度看,研究者可以深究新药的临床价值,享有科技论文署名权,且依据对本研究入组等贡献大小先后排名,在完成整体临床总结报告后,在申办方同意前提下,可以进一步发掘细分层次的用药价值,享有后续研究优先权,例如扩大适应症研究、优化用法用量研究,特殊人群研究等,享有共同申报科技计划、科技成果的权利。

从药厂角度,从药厂角度,作为完整的产品生命周期管理链条的最后一环,其重要性必要性是确定无疑的,而且可以提高企业产品的学术影响力,能占领学术制高点,增加专家团队建设,带动销售增长,开辟新区域额度营销业务等等。

梅斯医学:真实世界研究评价面临一个很大的挑战是混杂和偏倚,相关研究的壁垒有哪些?

吴龑:真实世界研究是基于临床真实的情况采取的一种非随机、开放性、不使用安慰剂的研究,因此其得出的结果具有很高的外延性和实践价值。现在很多人都在做真实世界的研究,但其实真实世界的研究并不是那么容易开展,在中国的大环境下,确实是比较挑战的事情。

其一,大多数医院只对新药研发感兴趣, 而在CFDA推行了广泛自查之后,科研人员会觉得做临床试验是负担。

其二,真实世界里很多研究病例费有限,有些药是病人自费的。所谓真实世界即针对病人疾病,临床医生觉得要用此药就用了,不受其他因素的影响。但是如果给了病人免费用药或给病人额外补助,有诱导病人用药的导向偏移,反而偏离真实的场景。

其三,一些大医院临床医生做研究有机会出文章的机会,真实世界需要的病人的样本量很大,研究占用了病人资源。

总而言之,真实世界研究因为要求的病人样本量大、费用相对较低、需要高级别的医生牵头等种种因素容易打击相关研究人员的积极性。但是如果国内做出相关的研究,对我们国家的临床科研和诊疗水平的提高是极具价值的,有质量的真实世界研究也会成为世界领先的研究结果。

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    2016-12-21 虈亣靌

    谢谢分享,学习了

    0

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    2016-12-14 艳阳天2016

    研究成果就是机遇?努力

    0

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    2016-12-14 知难而进

    谢谢分享!!!!!!!

    0

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    2016-12-14 399

    中国的研究,很多是无用的,拿着国家的基金

    0

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    2016-12-14 inter158

    真实世界研究是基于临床真实的情况采取的一种非随机、开放性、不使用安慰剂的研究,因此其得出的结果具有很高的外部有效性。现在很多人都在做真实世界的研究,但其实真实世界的研究并不是那么容易开展,在中国的大环境下,确实是比较难的事情。

    0

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