Clinical trials are crucial to determining the human safety and efficacy of new therapeutic innovations. Extraordinary amounts of human experiential data are generated over the course of any clinical trial, however, much of these data is never made publicly accessible. Improved, reliable data sharing is essential to inform clinical decisions and incentivize further therapeutic improvements; this need, and the call and concept to enhance patient-level clinical trial data accessibility is not new. Several recent public and private shifts in clinical data sharing policies and procedures promise to improve access and data utility to reduce waste in research and increase efficiency of evidence synthesis. Nonetheless, pharmaceutical industry remain reluctant to share full clinical data sets at some level to protect their commercial interests and avoid misuse of their data. Here, we review the landscape of emerging regulations related to the sharing of patient level data and current clinical data access models of major pharmaceutical companies. We also summarize the different measures that could satisfy both clinical data producers and users in achieving the benefits of accessing patient-level data while mitigating any associated risks.

临床试验对于确定人类安全性和新型治疗创新的功效至关重要。在任何临床试验过程中都会生成大量的人类实验数据，但是，其中许多数据从未公开发布。改善的，可靠的数据共享对于指导临床决策和激励进一步的治疗改进至关重要；这种需求以及增强患者水平临床试验数据可访问性的呼声和概念并不是什么新鲜事。临床数据共享策略和程序的最近几次公共和私人转变有望改善访问和数据实用性，以减少研究浪费并提高证据合成的效率。尽管如此，制药行业仍然不愿意在某种程度上共享完整的临床数据集，以保护其商业利益并避免滥用其数据。在这里，我们回顾了与主要制药公司共享患者水平数据和当前临床数据访问模型有关的新兴法规的情况。我们还总结了可以满足临床数据生产者和用户要求的各种措施，这些措施可以在降低任何相关风险的同时获得访问患者级别数据的好处。