Dillon Carlotta, Knapp Joyce, Stinson Mark
Dillon Consulting, Jupiter, FL, USA.
Knapp Healthcare Communications, New York, NY, USA.
J Patient Exp. 2020 Dec;7(6):978-981. doi: 10.1177/2374373520948441. Epub 2020 Oct 26.
Nearly all new product development teams at pharmaceutical companies will routinely conduct patient advisory boards. These board meetings will help collect and document the experience of patients and caregivers for medical product development and regulatory decision-making. Recently, in June 2020, The US Food and Drug Administration (FDA) published a final guidance on methodological patient-focused drug development (PFDD) to address, in a stepwise manner, how stakeholders (patients, researchers, medical product developers, and others) can successfully use these patient forums. In the process of developing this guidance, the FDA acknowledged that leading its own PFDD meetings, especially when limited to organized disease advocacy groups, cannot address the gaps in information on the patient perspective. So, it has expressed support for advancing the science and utilization of patient input other means. Because traditional methods of conducting patient advisory boards often do not achieve the full potential of patient centricity, the authors of this article share an approach to consider when selecting patient advisors, in order to gain the most actionable input to a product development team.
制药公司几乎所有的新产品开发团队都会定期召开患者咨询委员会会议。这些会议将有助于收集和记录患者及护理人员在医疗产品开发和监管决策方面的经验。最近，在2020年6月，美国食品药品监督管理局（FDA）发布了一份关于以患者为中心的药物开发（PFDD）方法的最终指南，逐步阐述了利益相关者（患者、研究人员、医疗产品开发商等）如何能够成功利用这些患者论坛。在制定该指南的过程中，FDA承认，自行主导PFDD会议，尤其是仅限于有组织的疾病倡导团体时，无法填补患者视角信息方面的空白。因此，它表示支持通过其他方式推进患者意见的科学研究和利用。由于传统的召开患者咨询委员会的方法往往无法充分发挥以患者为中心的潜力，本文作者分享了一种在选择患者顾问时可考虑的方法，以便为产品开发团队获得最具可操作性的意见。
