Koski Greg, Tobin Mary F, Whalen Matthew
Alliance for Clinical Research Excellence and Safety, One Broadway, 14th Floor, Cambridge, Massachusetts.
Alliance for Clinical Research Excellence and Safety, One Broadway, 14th Floor, Cambridge, Massachusetts.
Clin Ther. 2014 Oct 1;36(10):1356-70. doi: 10.1016/j.clinthera.2014.09.006. Epub 2014 Oct 23.
The pharmaceutical industry, once highly respected, productive, and profitable, is in the throes of major change driven by many forces, including economics, science, regulation, and ethics. A variety of initiatives and partnerships have been launched to improve efficiency and productivity but without significant effect because they have failed to consider the process as a system.
Addressing the challenges facing this complex endeavor requires more than modifications of individual processes; it requires a fully integrated application of systems thinking and an understanding of the desired goals and complex interactions among essential components and stakeholders of the whole. A multistakeholder collaborative effort, led by the Alliance for Clinical Research Excellence and Safety (ACRES), a global nonprofit organization operating in the public interest, is now under way to build a shared global system for clinical research. Its systems approach focuses on the interconnection of stakeholders at critical points of interaction within 4 operational domains: site development and support, quality management, information technology, and safety. The ACRES initiatives, Site Accreditation and Standards, Product Safety Culture, Global Ethical Review and Regulatory Innovation, and Quality Assurance and Safety, focus on building and implementing systems solutions. Underpinning these initiatives is an open, shared, integrated technology (site and optics and quality informatics initiative).
We describe the rationale, challenges, progress, and successes of this effort to date and lessons learned. The complexity and fragmentation of the intensely proprietary ecosystem of drug development, challenging regulatory climate, and magnitude of the endeavor itself pose significant challenges, but the economic, social, and scientific rewards will more than justify the effort.
An effective alliance model requires a willingness of multiple stakeholders to work together to build a shared system within a noncompetitive space that will have major benefits for all, including better access to medicines, better health, and more productive lives.
制药行业曾备受尊重、富有成效且利润丰厚，如今却因经济、科学、监管和伦理等诸多因素的驱动而处于重大变革的阵痛之中。为提高效率和生产力已发起了各种举措和合作，但未取得显著成效，因为它们未能将该过程视为一个系统。
应对这一复杂工作所面临的挑战，需要的不仅仅是对个别流程的修改；它需要全面综合地应用系统思维，并理解整个系统的期望目标以及基本组成部分和利益相关者之间的复杂相互作用。由卓越临床研究与安全联盟（ACRES）牵头的多方利益相关者合作努力正在进行中，ACRES是一家以公共利益为导向运营的全球非营利组织，旨在构建一个共享的全球临床研究系统。其系统方法侧重于在四个运营领域（机构开发与支持、质量管理、信息技术和安全）的关键互动点上利益相关者的相互联系。ACRES的举措，即机构认证与标准、产品安全文化、全球伦理审查与监管创新以及质量保证与安全，专注于构建和实施系统解决方案。支撑这些举措的是一个开放、共享、集成的技术（机构与光学及质量信息学计划）。
我们描述了迄今为止这项工作的基本原理、挑战、进展、成功之处以及经验教训。药物开发高度专有化的生态系统的复杂性和碎片化、具有挑战性的监管环境以及这项工作本身的规模带来了重大挑战，但经济、社会和科学回报将充分证明付出的努力是值得的。
一个有效的联盟模式要求多个利益相关者愿意共同努力，在一个非竞争性的空间内构建一个共享系统，这将为所有人带来重大利益，包括更好地获取药品、改善健康状况以及提高生活生产力。
