MarksMan Healthcare Communications, J1309, Amethyst Tower, PBEL City, Peeramcheruvu Village, Rajendra Nagar Mandal, Hyderabad, Telangana, 500091, India.
Pharmaceut Med. 2023 Jan;37(1):25-36. doi: 10.1007/s40290-022-00456-6. Epub 2023 Jan 5.
Real-world evidence (RWE) is clinical evidence on a medical product's safety and efficacy that is generated using real-world data (RWD) resulting from routine healthcare delivery. There are several sources of RWD, including electronic health records (EHRs), registries, claims/billing data, and patient-generated data, as well as those from mobile health applications and wearable devices. Real-world data from these sources can be collected and analysed through different study designs such as prospective and retrospective cohort studies, case-control studies, and pragmatic clinical trials. Real-world evidence in the form of post-marketing surveillance has been extensively used to generate pharmacovigilance data. Of late, it has been realised that, apart from safety, RWE has additional applications in different stages of the drug approval cycle, and can be used to optimize the design of randomised controlled trials (RCTs). There has been an increasing awareness and acceptance of RWE from different stakeholders, including physicians, pharmaceutical companies, payers, regulators, and patients. Several regulatory authorities have also created frameworks and guidelines for efficient harnessing of RWE while acknowledging several challenges in RWD collection and analysis. The purpose of this review is to offer an outline of the current information on RWE, its advantages and disadvantages, as well as the associated challenges and ways to overcome them, while also throwing some light on the future of RWE.
真实世界证据（RWE）是使用来自常规医疗保健提供的数据（RWD）生成的关于医疗产品安全性和疗效的临床证据。RWD 有几个来源，包括电子健康记录（EHRs）、登记处、索赔/计费数据以及患者生成的数据，以及来自移动健康应用程序和可穿戴设备的数据。可以通过不同的研究设计（如前瞻性和回顾性队列研究、病例对照研究和实用临床试验）来收集和分析来自这些来源的真实世界数据。以上市后监测形式出现的真实世界证据已被广泛用于生成药物警戒数据。最近，人们意识到，除了安全性之外，RWE 在药物批准周期的不同阶段还有其他应用，并且可以用于优化随机对照试验（RCT）的设计。不同利益相关者，包括医生、制药公司、支付方、监管机构和患者，对 RWE 的认识和接受程度都在不断提高。一些监管机构还为有效利用 RWE 制定了框架和指南，同时承认在 RWD 收集和分析方面存在若干挑战。本综述的目的是概述 RWE 的当前信息，包括其优缺点以及相关挑战和克服方法，并对 RWE 的未来进行展望。
