Executive Summary
临床开发的进步继续发展为执行临床试验中包括的大量过程 - 但成本继续上升，时间表延长，并且患者等待更长的时间才能改变生活，才能改变生活。
Technology and the breadth and depth of curated healthcare data sources continues to grow. Advanced analytics, artificial intelligence, and predictive analytics provide faster, more precise decision-making – yet adoption of these advancements continues to lag.
As clinical development evolves to a new age of trial conduct models, there is an increasing awareness of the need for practices that enable closer engagement with patients and for increased adoption of the rapidly changing technology landscape.
At IQVIA, we’re delivering on a clinical development strategy aligned towards more effective process and providing technology solutions that can adapt and leverage the change in trial designs, data sources and the fast-paced world of digital transformation. Technology is pushing the envelope for clinical trials toward digitization and virtualization. Both consumer and medical grade devices are seeing new entrants like wearables, sensors, connected devices, telemedicine, eConsent, etc. that imply an essential change to the approach of how临床试验数据is collected and monitored. And that has a definite impact on how we are managing the clinical monitoring workforce across the industry.
Currently, access to patients and monitoring of clinical investigator sites are the biggest factors driving costs higher and delaying completion of clinical trials. The increasing complexity of clinical trial systems and protocol designs needs novel and robust approaches to provide better patient safety, data quality and operational efficiency. This evolution highlights the value of models like risk-based monitoring (RBM) and centralized monitoring, and how these can further facilitate the digital trial to reduce study monitoring costs and improve the ability for monitoring and managing data quality and subject safety.
本文将特别讨论临床监测的组成部分以及临床研究助理（CRA/站点监测仪）的转化作用，这是临床试验未来的一部分。讨论的范围包括创新和新兴临床试验模型的各个方面，技术格局的变化，数字化和虚拟化试验的虚拟化，包括但不限于现场监控活动，以及，总而言之，对CRA的影响是其角色所需的技能和不断变化的责任。