Leslie Dan Faculty of Pharmacy, University of Toronto, Toronto, ON, Canada.
Quality HTA, Oakville, ON, Canada.
J Pharm Pharm Sci. 2023 Jul 17;26:11460. doi: 10.3389/jpps.2023.11460. eCollection 2023.
Real-world evidence (RWE) is being increasingly used by a wide range of stakeholders involved in the therapeutic product lifecycle but remains underutilized in the health technology assessment (HTA) process. RWE aims to fill the current evidence gaps, reduce the uncertainty around the benefits of medical technologies, and better understand the long-term impact of health technologies in real-world conditions. Despite the minimal use of RWE in some elements of HTA, there has been a larger push to further utilize RWE in the HTA processes. HTA bodies, as other stakeholders, work towards developing more robust means to leverage RWE from various data sources in the HTA processes. However, these agencies need to overcome important challenges before the broader incorporation of RWE into their routine practice. This paper aims to explore the extensive integration of RWE utilizing diverse sources of RWD. We discuss the utilization of RWE in HTA processes, considering aspects such as when, where, and how RWE can be effectively applied. Additionally, we seek the potential challenges and barriers associated with the utilization of different data sources.
真实世界证据(RWE)正被广泛应用于参与治疗产品生命周期的各种利益相关者中,但在健康技术评估(HTA)过程中仍未得到充分利用。RWE 的目的是填补当前证据空白,降低医疗技术效益的不确定性,并更好地了解医疗技术在实际情况下的长期影响。尽管在 HTA 的某些方面对 RWE 的使用较少,但人们一直在推动进一步在 HTA 流程中使用 RWE。HTA 机构与其他利益相关者一样,致力于开发更强大的手段,从 HTA 流程中的各种数据源中利用 RWE。然而,在将 RWE 更广泛地纳入其常规实践之前,这些机构需要克服重要的挑战。本文旨在探讨利用各种 RWD 广泛整合 RWE。我们讨论了在 HTA 流程中使用 RWE,考虑了 RWE 在何时、何地以及如何有效应用的问题。此外,我们还探讨了利用不同数据源所涉及的潜在挑战和障碍。