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临床试验的继续进化

如今,临床试验是高度结构化和监管,确保参与者的安全。在罗氏乐动-网站公司,我们致力于创造创新的临床试验,给病人最大利益。

今天,临床试验必须遵守严格的规则和道德的遵从性。临床试验是高度结构化的,除了功效外,他们还确定副作用,交互和长期的影响。

Heidemarie(也称为海蒂)Kletzl,临床药理学家,和弓佳,Pharmacometrician,这种级别的严密性是绝对必要的,让每一个的成功,非常甜美,特别是对于罕见疾病,治疗方案也经常匮乏。

“我们在严格监管的环境中工作,以确保我们收集必要的数据在一个安全的方式没有病人过度的风险,”海蒂解释道。”通常需要六个月到一年计划和建立一个试验,它可以花几年注册病人和收集所需的数据。所有这些高度控制程序是很重要的,因为最后我们需要确保医学工作的目的,是安全的。”

每个研究临床试验文件包几千页,因为每一块数据和所有的评估都必须报告。
通常的路线

现代临床试验的设计和操作执行的变化取决于研究的重点;乐动体育 博彩通常评估医学或设备是否功能和适合的目的,或决定了改善生活质量。

如果一种疾病有一个快速和高死亡率,科学家必须平衡强烈渴望得到一个新的医学患者迅速而坚持临床试验的要求。

“临床试验保证最大的严格评估一个潜在的新药的价值,”海蒂说,“但是我们需要快速行动,特别是对患者生活严重危及生命的疾病,时间是极其重要的。”

所以,团队要求:如果有一个更好的办法吗?

  • 二期——通常是一小群患者(通常是50到300之间的患者,根据疾病)接受医学评估不同剂量水平的安全性和有效性。

  • 第三阶段——大组的患者,通常1000 +,安全性和有效性测试建立在各自的疾病的新药。

  • 第四阶段治疗后,得到监管部门的批准(即。市场授权),信息风险、效益和最好的使用,以及数据的人服用药物的时间更长,从医生和病人聚集。

一种新药的典型发展道路分为四个阶段:
  • 第一阶段——研究乐动体育 博彩人员测试一种新的药物或治疗一小群健康的人来评估安全剂量范围和识别的副作用。

一个特制的审判拯救生命

发展的一个新的医学疾病发病率高,临床团队概念化一个新方法:结合第二和第三阶段到单个临床试验。为了缩短时间表和执行成功,团队,在周末和外部合作伙伴,不知疲倦地工作。

此外,因为最严重形式的疾病影响婴儿,症状通常出现在几个月内的出生和死亡发生之前他们的第二个生日,来自临床试验的数据需要来自婴儿。

一般来说,适当的剂量,确保药物的关键方面是有效和安全的,决定进行第二阶段的研究后,与一大群病人。然而,在这个快速的婴儿的小试验,确定合适的剂量根据正在进行的数据监测和剂量调整为每个单独的婴儿在研究过程中。

使用这种方法,首次剂量之间的时间给一个人提交批准减少来自十年,这通常是需要标准的发展道路,不到4。”这是可喜的,看看有多少病人的生命得救了,因为我们可以使用这种大胆而创新的临床试验设计,”海蒂说。

“很有压力”,由美说,“我很紧张,特别是婴儿,但最终,作为一个团队的一部分,为市场带来治疗可以拯救许多病人,包括儿童,在罗氏公司是我职业生涯的亮点。”乐动-网站

为他们出色的工作,给病人带来新的分子以一种不同寻常的跳出去思考的方式,由美,海蒂,他们的同事从罗氏项目团队和外部合作伙伴获得两个奖项,从英国药理学会药物研究和社会分别发生在2021年。乐动体育 博彩乐动-网站

它需要一个村庄

弓和海蒂收集数据从试验的参与者的血液,然后开发一个模型和运行多个模拟以确定适当的剂量。但他们只有两个所需的数百人开发一个新的医学和交付给病人那些船上把受试者的医疗团队照顾他们的数据管理团队,个人分析实验室,毒理学家、统计学家、医学作家和生物识别技术团队。更不用说慈善机构和研究机构的不懈努力筹集资金和疾病意识。乐动体育 博彩

“就像抚养一个孩子需要一个村庄,”海蒂说,“它需要一个非常大的团队运行成功的临床试验。”

而现代临床试验从战场上取得了长足的进步,总有改进的余地。”,我们不会停止创新,一起工作,”海蒂承诺,“继续采取临床试验更大的新的高度。”

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