Construction and Practical Verification of a "Risk-Collaboration-Digitalization" Trinity Project Management Model for Cardiovascular and Cerebrovascular Innovative Drug R&D

Abstract

Cardiovascular and cerebrovascular diseases (CCVDs) have become a major global public health challenge. The research and development (R&D) of innovative drugs for CCVDs faces dilemmas including long R&D cycles (12-15 years on average), high costs (USD 2.5 billion per drug on average), and high clinical failure rates (over 40% for Phase III clinical trials) due to characteristics such as target complexity, strict requirements for hard clinical endpoints, and strong demand for multidisciplinary collaboration. Traditional project management models, which focus on "schedule-cost" dual control, are insufficient to adapt to the scientific uncertainties and cross-domain collaboration needs in CCVD innovative drug R&D. Based on the full R&D process of CCVD innovative drugs (drug discovery → preclinical research → Phase I/II/III clinical trials → New Drug Application, NDA), this study proposes a "Risk-Collaboration-Digitalization" trinity project management model through literature analysis, risk map construction, cross-functional team (CFT) mechanism design, and digital tool integration. Taking a new PCSK9 inhibitor (a lipid-lowering innovative drug for CCVDs) R&D project of a pharmaceutical enterprise as a verification case, key indicators before and after the model application were compared: the R&D cycle was shortened by 15.2%, the success rate of Phase III clinical trials increased by 21.3%, the one-time approval rate of NDA rose from 72% to 89%, and R&D costs decreased by 12.5%. This study fills the theoretical gap in specialized project management for CCVD innovative drugs and provides an operable practical framework for pharmaceutical enterprises to improve the efficiency and success rate of innovative drug R&D.