Excerpta Medica B.V., Amsterdam, The Netherlands.
International Society for Medical Publication Professionals (ISMPP), Tarrytown, NY, USA.
Health Econ Policy Law. 2022 Oct;17(4):416-427. doi: 10.1017/S1744133122000056. Epub 2022 Apr 6.
There is currently a heightened need for transparency in pharmaceutical sectors. The inclusion of real-world (RW) evidence, in addition to clinical trial evidence, in decision-making processes, was an important step forward toward a more inclusive established value proposition. This advance has introduced new transparency challenges. Increasing transparency is a critical step toward accelerating improvement in type, quality, and access to data, regardless of whether these originate from clinical trials or from RW studies. However, so far, advances in transparency have been relatively restricted to clinical trials, and there remains a lack of similar expectations or standards of transparency concerning the generation and reporting of RW data. This perspective paper aims to highlight the need for transparency concerning RW studies, data, and evidence across health care sectors, to identify areas for improvement, and provide concrete recommendations and practices for the future. Specific issues are discussed from different stakeholder perspectives, culminating in recommended actions, from individual stakeholder perspectives, for improved RW study, data, and evidence transparency. Furthermore, a list of potential guidelines for consideration by stakeholders is proposed. While recommendations from different stakeholder perspectives are made, true transparency in the processes involved in the generation, reporting, and use of RW evidence will require a concerted effort from all stakeholders across health care sectors.
目前，制药行业需要提高透明度。在决策过程中纳入真实世界（RW）证据，除了临床试验证据，这是朝着更具包容性的既定价值主张迈出的重要一步。这一进展带来了新的透明度挑战。提高透明度是加速改善数据的类型、质量和获取的关键步骤，无论这些数据是来自临床试验还是来自 RW 研究。然而，到目前为止，透明度的提高相对局限于临床试验，对于 RW 数据的生成和报告，仍然缺乏类似的透明度期望或标准。本文旨在强调在整个医疗保健领域提高 RW 研究、数据和证据透明度的必要性，确定需要改进的领域，并为未来提供具体的建议和实践。从不同利益相关者的角度讨论了具体问题，最终为改进 RW 研究、数据和证据透明度提出了来自各个利益相关者的建议行动。此外，还提出了一份潜在指南清单供利益相关者考虑。虽然从不同利益相关者的角度提出了建议，但要实现 RW 证据生成、报告和使用过程的真正透明度，需要医疗保健各个领域的所有利益相关者共同努力。
