Covid-19大流行加速了这一进程, 我们已经看到了临床试验的转变, 通过改变它们的执行方式, 监管, 和感知. 在本文中, we will explore the recent transformations in the world of clinical trials and offer insights into their potential future direction.
临床试验的最新变化
One of the most prominent recent developments in clinical trials is the increasing use real-world evidence (RWE). RWE使用来自各种来源的数据, 包括电子健康记录, 保险索赔, 可穿戴设备. This allows researchers to gather data beyond traditional clinical trial settings, providing a more comprehensive view of a treatment's effectiveness and safety.
The COVID-19 pandemic accelerated the adoption of remote and decentralized clinical trials, 也被称为虚拟, 在家或非现场试验. With the implementation of telemedicine and home-based monitoring, patients can take part in trials from the comfort of their homes, 消除了前往特定地点的需要. 这种方法增加了患者的参与度, 提高学习效率, 最终将有助于更快地将药物推向市场.
There has also been a growing emphasis on patient-centricity in more recent clinical trials. Regulatory agencies and sponsors are actively involving patients in the trial design process to ensure that the research is aligned with patients' needs and preferences. This approach not only enhances the relevance of the trials but also increases patient recruitment and retention rates.
Several countries have undergone significant changes in their clinical trial regulations to adapt to the changing landscape.
美国: 2023年6月, FDA宣布了一份新的指导草案, E6(R3)良好临床操作规范(GCP),”. The latest draft guidance includes updated recommendations and “鼓励创新, 注重质量, and establishes proportionate and risk-based approaches for conducting clinical trials, 同时尽量减少不必要的复杂性.” New recommendations include encouraging the use of innovative digital health technologies (DHTs), 比如可穿戴传感器, 提高数据收集的效率.
欧盟: The EU has implemented a new Clinical Trials Regulation (CTR) to create a more unified and efficient framework for clinical trials across member states. CTR的, 2023年初全面实施, 简化审批流程, 协调试验设计, 并为提交试验文件建立了一个单一的门户. These changes are expected to reduce administrative burdens and enhance the competitiveness of EU clinical research.
印度: In 2019, the Ministry of Health and Family Welfare (MoHFW), Government of India released updated 新药和临床试验规则, designed to help streamline regulations and guide clinical trial conduct in India. These updated rules include new time limits for responses to submissions for application for clinical trials.
英国: 2023年10月宣布, a series of new measures will be introduced by the Medicines and Healthcare products Regulatory Agency (MHRA) to streamline clinical trial approvals. 在新框架下, clinical trials application processes in the UK will be more streamlined and flexible without compromising on safety, helping to make it faster and easier to gain approval and to run clinical trials in the UK. The changes will also result in a framework that is responsive to diverse types of trials and designs, and supportive of new ways of conducting trials such as decentralised trials.
对未来临床试验的预测
The future of clinical trials will continue to be shaped by ongoing developments and emerging trends.
Here are some predictions on what we think will shape clinical trials in the coming years:
高级数据分析: The integration of artificial intelligence and machine learning will revolutionize data analysis in clinical trials. 预测模型, 数据挖掘, and real-time monitoring will enable more efficient trial designs, 更好的病人选择, 及早发现安全隐患.
扩大分散审判: 分散和远程审判的趋势将会扩大, 使患者更方便地参与. Regulatory agencies will further support this shift by providing clear guidelines for virtual trials.
加强规管灵活性: Regulatory agencies are expected to keep a more flexible approach, 能够更快地应对新出现的卫生危机. Collaborative relationships between the pharmaceutical industry and regulatory bodies are likely to continue evolving to streamline the approval process.
个性化医疗: Advancements in genomics and biomarker discovery will drive the development of targeted therapies. Clinical trials will need to adapt to consider individual genetic profiles and treatment responses, 为靶向治疗铺平了道路.
真实世界的数据将对决策至关重要: Emerging technologies and new devices will enable companies to gather large amounts of real-world evidence. 这个数据, along with data from clinical research will help to guide pharmaceutical companies’ approach towards clinical trials.
The world of clinical trials has evolved significantly in recent years, 强调真实世界的证据, patient-centricity, 简化监管程序. 这些变化使临床试验更加有效, 便于患者使用, 全球联系更加紧密. 随着高级数据分析的发展，未来的前景更加光明, 分散的试验, 全球协调, 个性化医疗的兴起. As we continue to navigate the ever-changing landscape of clinical trials, the ultimate beneficiaries will be patients who receive safer and more effective treatments because of these innovations.
资源:
http://ijper.org/sites/default/files/IndJPhaEdRes_53_4s_451_0.pdf