《生命科学》 2024, 36(11): 1315-1320

虚拟临床试验的发展趋势及对策建议

孟海华¹ , 孙　立² , 陈明伟^1,*

¹上海市生物医药科技产业促进中心，上海 201203 ²上海市投资促进服 务中心(上海市中小企业上市促进中心)，上海 200125

摘　要：

虚拟临床试验作为一种基于计算机模拟和数学模型的临床试验方法，能更加高效、精准、安全地评估新药，优化研究决策和治疗方案，对破解传统药物研发周期长、成本高等瓶颈问题具有重要价值。然而，虚拟临床试验也面临模型与算法、数据安全及应用范围等方面的挑战。对此，本文建议通过项目支持、跨学科复合人才培养、建立统一标准、细化监管政策等措施，推动虚拟临床试验在更广泛领域的应用，进而加速生物医药研发的转型升级与发展。

通讯作者：陈明伟 , Email:alex8088@126.com

Research on the development trends and countermeasures of virtual clinical trials

MENG Hai-Hua¹ , SUN Li² , CHEN Ming-Wei^1,*

¹Shanghai Center of Biomedicine Development, Shanghai 201203, China ²Shanghai Investment Promotion Service Center (Shanghai SEMs Going Public Promotion Center), Shanghai 200125, China

Abstract:

Virtual clinical trials (VCTs), a clinical trial method based on computer simulation and mathematical models, can evaluate new drugs more efficiently, accurately, and safely, optimize research decisions and treatment plans, and have significant value in addressing bottleneck problems such as long development cycles and high costs of traditional drugs. However, VCTs also face challenges in terms of models and algorithms, data, and application scope. In this regard, this article proposes countermeasures and suggestions such as project support,  composite talent cultivation, establishment of standards, and formulation of regulatory rules to promote its application in a wider range of fields and facilitate the rapid upgrading and development of biomedical research.

Communication Author：CHEN Ming-Wei , Email:alex8088@126.com