精鼎医药全球患者咨询委员会落地中国,推动以患者为中心的药物开发

2020-09-10 medsci medsci

2020年9月10日,精鼎医药(Parexel),一家领先的、致力于在临床开发到商业化的各个阶段加速创新疗法的研发和上市以改善人类健康的解决方案提供者,近日宣布在中国成立患者咨询委员会,并于上海举办首

2020年9月10日,精鼎医药(Parexel),一家领先的、致力于在临床开发到商业化的各个阶段加速创新疗法的研发和上市以改善人类健康的解决方案提供者,近日宣布在中国成立患者咨询委员会,并于上海举办首次圆桌会议。七名肿瘤和罕见病领域的患者/患者家属作为顾问参与了此次会议,与精鼎医药的专家共同探讨如何改善患者的临床试验体验。精鼎医药全球患者咨询委员会聚焦以患者为中心的药物开发,旨在通过收集患者反馈,帮助提升临床试验的患者参与度,加快药物开发全生命周期中各个阶段的进程。

会上,患者们通过分享自己参与临床试验的经历和感受,对一些影响患者参与体验的问题提供了指导和见解,其中包括在临床试验中如何加强医患沟通、患者组织如何参与、临床试验资源地域协调分配的优势、如何完善患者报销流程等问题。

精鼎医药高级医学总监杨柳青表示:“对于临床开发者来说,‘以患者为中心’意味着我们必须将患者作为临床研究的合作伙伴,而不仅仅是研究对象。这要求我们在药物开发的过程中能够及时、充分地倾听患者的声音,了解他们的需求和挑战,从而帮助患者减轻参与临床试验的负担与障碍。”

以患者为中心的药物开发,是指让患者参与设计和执行的试验,旨在贴近患者需求,从而鼓励患者参加试验。由精鼎医药委托经济学人智库撰写的一项报告显示,以患者为中心的策略能够显著优化临床试验的流程和结果,加速患者受益于创新药品和疗法:在以患者为中心的试验中,患者招募时间缩短了40%,药物上市的成功率提升了19%。 

为了更好地将患者需求融入到药物开发的全生命周期中,精鼎医药于2019年12月在美国成立了全球首个患者咨询委员会,与不同疾病领域的患者建立长期的合作关系。患者咨询委员会将定期举办会议,针对药物开发领域的相关话题,收集患者顾问的观点和建议。目前,精鼎医药已经在美国和欧洲举办了四次患者咨询委员会会议,与全球20位患者顾问就各种临床疾病(包括肿瘤和罕见病)展开了紧密合作。

精鼎医药法规咨询部副总裁(技术)李娅杰表示:“为了帮助解决患者在临床试验中面临的挑战,精鼎医药一直不断创新,推动实施以患者为中心的策略。接下来,精鼎医药将落地一系列项目去实现这些目标。相信通过这些人性化的服务和创新技术的使用,能够有效优化患者体验,为患者提供便利和支持。”

此外,会上还针对包括分散式试验在内的一些药物开发创新手段进行了讨论,以及它们是如何在提升操作效率的同时,还兼顾患者的便利和安全的。目前,精鼎医药在全球已开展了(包括已完成和正在进行中)90余例分散式试验。对于如何更好地在中国开展分散式试验,精鼎医药在会上征询了患者顾问的意见。精鼎医药信息技术亚太地区副总裁陈建男表示:“虽然分散式试验的执行和推广在国内尚处于起步阶段,但通过与患者的交流,我们能够尽早地了解中国患者对于这一创新方式的看法,帮助完善试验设计,从而在未来更好地服务患者。”

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    2020-09-20 Spider

    学习中

    0

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    2020-09-12 cathymary
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    2020-09-10 何鑫杰

    学习了

    0