利用真实世界证据 (RWE)：医学事务 (MA) 团队的最佳实践

真实世界证据 (RWE) 正在透过提供来自日常医疗实践而非传统临床试验的见解来改变医疗事务 (MA)。 RWE 包括来自电子病历、保险索赔、病人登记和穿戴式装置的数据，可以提供对治疗结果的广泛了解。

对于 MA 团队来说，RWE 对于推动更好的患者结果、提供临床决策资讯和支援监管提交至关重要。然而，必须解决数据品质、整合和合规性方面的课题。

FirstWord 向製药业 MA 顾问 Steven Camper 询问了 MA 团队克服障碍、确保资料完整性和最大限度地发挥 RWE 对医疗保健影响的策略和最佳实践。

主要的问题

• 1.请向我们介绍您在 MA 的 RWE 背景和经验。
• 2.随着 RWE 重要性的日益增加，您的角色发生了怎样的变化？
• 3.将RWE成功纳入MA策略的关键步骤是什么？
• 4.您的组织或产业中有哪些成功实施 RWE 的例子？
• 5.MA 团队在使用 RWE 时面临哪些常见课题？
• 6.您会向 MA 团队推荐哪些最佳实践，以最大限度地提高 RWE 的价值？
• 7.我们如何确保RWE的品质与可靠性？
• 8.使用 RWE 时，MA 团队应考虑哪些监管和道德因素？
• 9.您如何确保遵守这些规定？
• 10.您预见在 MA 中使用 RWE 会出现哪些趋势？
• 11.MA 团队如何为这些趋势做好准备？

我们的报告特色：

FirstWord Reports 是值得信赖的行业领导者，专注于製药领域，为生物製药专业人士和决策者提供深入、可操作的见解。我们深厚的行业知识使我们能够提供相关且有价值的见解，帮助我们的客户了解新兴趋势并有效地解决复杂的课题。我们的报告以广泛的研究以及来自领先专家和 KOL 的独立、公正的见解为后盾，为您提供所需的准确性和可信度。独家采访和数据以及持续的市场监控使我们能够全面了解市场动态。我们的报告涵盖 40 多个动态疾病领域、包括 KOL 洞察和定量医生调查在内的医生情报以及行业专家对 MA、数位健康、销售和行销、市场准入和其他领域问题的看法，可以帮助您做出更明智的、数据驱动的决策，以在快速变化的行业中保持竞争力。

Real-world evidence (RWE) is transforming medical affairs by providing insights from everyday medical practice, unlike traditional clinical trials. Including data from electronic health records, insurance claims, patient registries and wearable devices, RWE offers a broader understanding of treatment outcomes.

For medical affairs teams, RWE is essential for driving better patient outcomes, informing clinical decisions and supporting regulatory submissions. Challenges arising around data quality, integration and compliance, however, must be addressed.

FirstWord spoke to Stephen Camper, a medical affairs consultant to the pharma industry, about the strategies and best practices medical affairs teams can use to overcome obstacles, ensure data integrity and maximise RWE's impact on healthcare.

Key Questions Answered:

• 1. Can you share a bit about your background and experience with RWE in medical affairs?
• 2. How has your role evolved with the increasing importance of RWE?
• 3. What are the key steps to start successfully integrating RWE into medical affairs strategies?
• 4. Can you provide examples of successful RWE implementation in your organisation or industry?
• 5. What are the common challenges medical affairs teams face when using RWE?
• 6. What best practices would you recommend for medical affairs teams to maximise the value of RWE?
• 7. How can teams ensure the quality and reliability of the RWE they use?
• 8. What regulatory and ethical considerations should medical affairs teams keep in mind when using RWE?
• 9. How do you ensure compliance with these regulations?
• 10. What future trends do you foresee in the use of RWE in medical affairs?
• 11. How can medical affairs teams prepare for these trends?

Methodology

Dossier reports are developed from independent and concise analysis derived from original industry surveys and in-depth interviews with industry thought leaders. Reports analyse in detail significant developments and market trends that pharma executives need to understand if they are to manage the opportunities and challenges that lie ahead. The focus of each report is defined by a review of the secondary literature and any knowledge gaps identified. Based on this initial research, an evidence-based and expert-informed discussion guide is developed to ensure the research answers the most critical questions. Additionally, robust screening criteria are established to ensure that those interviewed are qualified in terms of their experience, knowledge and stature to speak on the topic.

What makes our reports different?

FirstWord Reports, a trusted industry leader with an exclusive focus on the pharmaceutical sector, delivers in-depth, actionable insights for biopharma professionals and decision-makers. Our deep industry knowledge enables us to provide relevant and valuable insights that help you identify emerging trends and navigate complex challenges effectively. Backed by extensive research and independent, impartial insights from leading experts and KOLs, our reports deliver the accuracy and reliability you need. With exclusive access to interviews and data unavailable elsewhere, along with ongoing market monitoring, we give you a comprehensive view of market dynamics. Covering over 40 dynamic disease areas and providing physician intelligence, including KOL insights and quantitative physician surveys, as well as industry expert views on issues in medical affairs, digital health, sales & marketing, market access, and other areas, our reports empower you to make smarter, data-driven decisions and maintain a competitive edge in a fast-moving industry.