病人的声音是如何改变药吗

How well are you able to carry out your usual social activities? How does your sleep issue affect your ability to do things with your family? Do you feel like you’re getting better?
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\r\nThese questions may seem unusual, but the answers are critical in understanding a patient’s disease burden, specifically, the health-related quality of life impact of a treatment, according to one of AbbVie’s leaders in patient-centered outcomes research.
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\r\nThis leader may be new to AbbVie, but her focus in patient experience isn’t. Katy Benjamin, Ph.D., director, health economics and outcomes research, leverages her expertise in developing tools to measure treatment outcomes from the patients’ perspective. She digs into what patients think and feel, combining this valuable information with more traditional clinical data to understand the burden of disease and how our molecules and medicines may reduce that burden – ultimately, to help create better treatments for patients. 
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\r\nWe sat down with Katy to understand the role of the patient-centered research (PCR) group within AbbVie and how some critical insights are discovered outside of the lab.

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你能执行你的平时的社交活动吗?你的睡眠问题如何影响你做事的能力和你的家人吗?你感觉喜欢你越来越好吗?

这些问题似乎不同寻常,但答案是关键在理解病人的疾病负担,具体来说,治疗的健康相关生活质量的影响,根据AbbVie领导人之一,以病人为中心的研究结果。

这AbbVie领导人可能是新的,但她在病人的经验不是焦点。凯蒂·本杰明博士、主任、卫生经济学和研究结果,利用她的专业开发工具从病人的角度来衡量治疗结果。她深入病人的想法和感受,结合这些有价值的信息和更传统的临床数据了解疾病负担和我们的分子和药物可以减少负担,最终,帮助创造更好的治疗病人。

我们坐下来和凯蒂去理解以病人为中心的作用研究(PCR)集团内部AbbVie和一些关键的见解如何发现外部的实验室。

Katy Benjamin, Ph.D.: I’ve always been interested in patient behavior – what motivates someone to go to the doctor, to stick with a treatment. To answer the question: What are the factors that make people believe they’re getting better?
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\r\nMy background is in psychiatric social work, with a master’s in that area, and a master’s from Harvard in public policy. Before earning my doctorate at Johns Hopkins, I worked as a social scientist for the Agency for Healthcare Research & Quality, a U.S. public health agency, leading early efforts to understand how to measure the patients’ perspective when evaluating the effectiveness of medical care. I then worked in consulting for many years to develop and validate questionnaires to measure how patients viewed their health and their medical treatments, mainly for use in clinical trials. Over the course of my career, I’ve had the opportunity to talk to hundreds of patients with a wide variety of medical conditions.
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\r\nI had to understand the “what” and “why” for patient outcomes. And as a social worker, I was trained to talk to people. My research training gave me the tools to turn these insights into questionnaires to measure what’s important to patients.

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凯蒂·本杰明博士:我一直感兴趣的病人行为——什么促使人去看医生,坚持治疗。回答这个问题:是什么因素使人们相信他们得到更好吗?

我的背景是在精神病社会工作,硕士,硕士和哈佛公共政策。赚我的约翰霍普金斯博士学位之前,我做过社会科学家卫生保健研究与质量,美国公共卫生机构,早期努力理解如何衡量病人的角度在评估医疗的有效性。然后我在咨询工作多年开发和验证问卷来测量病人如何看待他们的健康和他们的医学治疗,主要用于临床试验。在我的职业生涯中,我有机会跟患者数以百计的各种各样的医疗条件。

我必须了解“是什么”和“为什么”患者的结果。作为一名社会工作者,我被训练与人交谈。我的研究训练给我的工具把这些见解问卷测量重要的病人。

Benjamin: The role of the PCR team is to help bring patient centricity – the voice of the patient – to AbbVie. That can be applied in a broader sense, like how we approach unmet need in medical care based on what patients can tell us. It’s also applied to how we build our clinical program and specific clinical trials, ensuring we put measures in place to help us understand patient perspective in terms of evaluating the efficacy of our treatments. 
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\r\nPatient reported outcomes (PROs), or data that comes directly from the patient, are an important way to measure their experience.  They can be assessed in clinical trials, and analyzed relative to clinical data. They can also be assessed in real world studies. Real world evidence (RWE) is becoming increasingly important for us to truly understand the complexity of diseases and the burdens patients face. We need to tie our programs to the real world, and that’s why AbbVie recently created an evidence generation team within HEOR to strengthen our approach. We in PCR work closely with our RWE colleagues to understand the whole picture of people’s medical care experiences – what’s happening and why.

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本杰明:PCR团队的作用是帮助患者中心性AbbVie -病人的声音。可以应用在更广泛的意义上,就像我们如何处理未满足的需要医疗护理根据病人可以告诉我们。也适用于我们如何建立我们的临床项目和具体的临床试验,确保我们把措施来帮助我们理解病人的角度而言,评估治疗的疗效。

病人报告结果(优点),或数据直接来自病人,是一种很重要的方式来衡量他们的经验。他们可以评估在临床试验中,相对于临床数据和分析。它们也可以在现实世界的研究评估。现实世界的证据(RWE)正变得越来越重要对我们真正理解的复杂性疾病,患者负担的脸。我们需要把我们的程序绑在现实世界中,这就是为什么AbbVie最近创建了一个证据代团队内HEOR加强我们的方法。我们在PCR与RWE同事紧密合作,了解人们的医疗经历的全貌——发生了什么和为什么。

Benjamin: This hits on one of my personal passions, and that’s really listening to what the patient has to say. If we look back at the history of drug development, the voices of patients typically weren’t considered important. Instead, we focused on the voice of the medical community and clinical outcomes – e.g., whether the tumor shrinks or if a laboratory value changes.
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\r\nBut, these types of clinical outcomes may not be something patients are noticing themselves. Instead, they may be having other experiences that we don’t know about unless we ask. A great way to do patient-centric research is by working with patient organizations. For example, we may learn of a symptom people are experiencing, which isn’t being picked up by clinicians who are instead focusing on a more prominent symptom. We can also understand more comprehensively which symptoms are most important to measure because they impact the aspects of patients’ lives that are most important to them. We gain this initially through qualitative research studies and in turn get a broader understanding beyond specific groups in clinical trials. Regulators and Health Technology Assessment (HTA) authorities are increasingly requiring that we understand and demonstrate to them the impact our novel medicines are having on patients.  

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本杰明:点击我的一个个人的激情,这就是听病人说。如果我们回顾药物开发的历史,病人的声音通常不被认为是重要的。狗万正网地址相反,我们专注于医疗社区和临床结果的声音——例如,肿瘤缩小或如果实验室值是否更改。

但是,这些类型的临床结果可能不是病人注意自己的东西。相反,他们可能有其他的经验,我们不知道,除非我们问。成规研究的一个很好的方法就是通过与病人组织。例如,我们可以学习的一个症状人经历,这并不是在临床医师而非关注更重要的症状。我们也可以了解更多全面衡量哪些症状最重要,因为他们影响患者生活的方面,是最重要的。我们获得这最初通过定性研究,进而得到更广泛地了解超越特定的组在临床试验中。监管机构和卫生技术评估(HTA)当局越来越要求我们理解和展示他们我们的新型药物对患者的影响。

Benjamin: We’re seeing a growing awareness for how important the patient point of view is to understand the quality and value of medical treatments across the world, reflected in government initiatives that include patient perspective when assessing the value of both new and existing medical treatments.
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\r\nIn the U.S., building on previous initiatives like workshops with patient advocacy groups, the FDA is developing guidance documents on how to appropriately collect, analyze and report data on patient experience. These insights on how patients view their condition, treatment and participation in clinical studies are important to us in industry as well as to regulators. These guidances illustrate that regulators recognize the value of patient-reported outcomes and offer practical information on how this information can impact product labeling, including the uses and effectiveness of treatments.
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\r\nThe European Medicines Agency (EMA), which evaluates new drug applications across the European Union, takes patient-centered outcomes evidence into account in its evaluation of treatment efficacy and approval, as do most country regulatory agencies. The EMA and FDA are collaborating on strategies to include the patient voice in their regulator decision-making.

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本杰明:我们看到越来越多的人意识到对病人的重要性的观点是理解世界各地医学治疗的质量和价值,体现在政府的举措,包括病人的角度在评估新的和现有的医学治疗的价值。

在美国,建立在先前的车间和病人团体,FDA正在开发指导文件如何适当地收集、分析和报告数据对病人的经验。这些见解在病人如何看待他们的病情、治疗和参与临床研究是重要的对我们在工业以及监管机构。这些指引说明管理者意识到patient-reported结果的价值,并提供实用的信息,这些信息如何影响产品标签,包括使用和治疗的有效性。

欧洲药品局(EMA),这在欧盟评估新药应用程序,考虑了以病人为中心的结果的证据的评估治疗疗效和批准,大多数国家的监管机构。EMA和FDA合作策略包括病人的声音在他们的监管机构的决策。