临床试验转化：最近的变化和未来的预测
Catherine Taylor
Communication & Content Manager
临床试验在推进医学研究中发挥着关键作用, improving patient care, and are an essential part of new drug development. In recent years, 在技术进步的推动下，临床试验发生了重大变化, regulatory shifts, and a growing emphasis on patient-centricity.
Accelerated by the Covid-19 pandemic, we have seen a shift in clinical trials, with changes to the way they are conducted, regulated, and perceived. In this article, 我们将探讨临床试验领域的最新转变，并对其潜在的未来方向提供见解.
Recent Changes in Clinical Trials
临床试验中最近最突出的发展之一是越来越多地使用真实世界证据（RWE）. RWE uses data from a variety of sources, including electronic health records, insurance claims, and wearable devices. 这使得研究人员可以收集传统临床试验设置之外的数据, 为治疗的有效性和安全性提供更全面的观点.
COVID-19大流行加速了远程和分散临床试验的采用, also known as virtual, at-home or site-less trials. 随着远程医疗和家庭监控的实施, patients can take part in trials from the comfort of their homes, eliminating the need to travel to specific sites. This approach has shown increased patient participation, increased study effectiveness, and will ultimately help to get drugs to market faster.
在最近的临床试验中，也越来越强调以患者为中心. 监管机构和赞助商正在积极让患者参与试验设计过程，以确保研究符合患者的需求和偏好. 这种方法不仅提高了试验的相关性，而且增加了患者招募和保留率.
一些国家的临床试验法规已经发生了重大变化，以适应不断变化的形势.
United States: In June 2023, the FDA announced the availability of a new draft guidance, “E6(R3) Good clinical Practice (GCP),”. The latest draft guidance includes updated recommendations and “encourages innovation, focuses on quality, 并为开展临床试验建立相应的、基于风险的方法, while minimizing unnecessary complexities.新的建议包括鼓励使用创新的数字卫生技术。, such as wearable sensors, to increase the efficiency of data collection.
European Union: 欧盟实施了一项新的临床试验法规（CTR），为成员国的临床试验创建一个更统一、更有效的框架. The CTR, fully implemented in early 2023, simplifies the approval process, harmonizes trial designs, and establishes a single portal for trial submissions. 预计这些变化将减轻行政负担，提高欧盟临床研究的竞争力.
India: 2019年，印度政府卫生和家庭福利部（MoHFW）发布了最新的 New Drugs and Clinical Trials Rules旨在帮助简化监管并指导印度的临床试验进行. 这些更新后的规则包括对提交的临床试验申请作出答复的新时限.
United Kingdom: Announced in October 2023, 英国药品和保健m88官方监管局（MHRA）将推出一系列新措施，以简化临床试验审批. Under the new framework, 在不影响安全性的前提下，英国的临床试验申请流程将更加精简和灵活, 这有助于更快、更容易地获得批准，并在英国进行临床试验. 这些变化还将产生一个对不同类型的试验和设计作出反应的框架, 并支持进行分散试验等新方法.
Predictions for the Future of Clinical Trials
临床试验的未来将继续受到持续发展和新趋势的影响.
以下是我们对未来几年影响临床试验的一些预测：
Advanced Data Analytics: 人工智能和机器学习的融合将彻底改变临床试验中的数据分析. Predictive modelling, data mining, 实时监测将使试验设计更有效, better patient selection, and early identification of safety concerns.
Expansion of Decentralized Trials: The trend of decentralized and remote trials will expand, making participation more convenient for patients. 监管机构将通过为虚拟试验提供明确的指导方针，进一步支持这一转变.
Enhanced Regulatory Flexibility: 预计监管机构将采取更加灵活的做法, enabling faster responses to emerging health crises. 制药业和监管机构之间的合作关系可能会继续发展，以简化批准程序.
Personalized Medicine: 基因组学和生物标志物发现的进步将推动靶向治疗的发展. 临床试验需要考虑个体的基因特征和治疗反应, paving the way for targeted therapies.
Real-world data will be critical in decision making: 新兴技术和新设备将使公司能够收集大量真实世界的证据. This data, 与临床研究数据一起，将有助于指导制药公司的临床试验方法.
近年来，临床试验领域发生了重大变化, with an emphasis on real-world evidence, patient-centricity, and streamlined regulatory processes. These changes have made clinical trials more efficient, patient-friendly, and more globally connected. The future holds even more promise with advanced data analytics, decentralized trials, global harmonization, and the rise of personalized medicine. 随着我们在不断变化的临床试验领域继续前行, 最终的受益者将是患者，他们将因为这些创新而获得更安全、更有效的治疗.
Resources:
http://ijper.org/sites/default/files/IndJPhaEdRes_53_4s_451_0.pdf