艾昆纬-数字化转型：临床试验的新时代（英）

White PaperDigital Transformation: A New Era for Clinical Trials NATALIA KOTCHIE, Senior Vice President, Applied Data Science Center CHRISTINA LARSEN, Director, Innovation, Data Sciences, Safety & Medical RAJNEESH PATIL, Vice President, Digital Strategy & InnovationSABRINA STEFFEN, Vice President, Head of Innovation & Data Strategy for Data Sciences, Safety & MedicalTable of contentsIntroduction 3Technology trends in clinical development 3Design and planning: Reducing ‘white space’ 6Early iterative planning and benchmarking 6Real-time scenario planning 7Demand for real-time data for decision-making 7Need for increased site support 7Data flow and digitization, enabling faster insights 8Call for common data models and standards 9Remaining bottlenecks: ‘Collaboration tax’ and the need for industry-wide adoption 9Conclusion 9References 10About the authors 11 iqvia.com | 3Digital transformation is happening all around in everyday life. Smartphones, watches and laptops connect and sync seamlessly; AI-driven ecommerce improves consumer experiences for shopping, streaming entertainment and social media. In the retail sector in particular, digital transformation is adding value for customers. Operational processes are being successfully standardized. One example is the use of stock-keeping units (SKUs) that appear as barcodes or quick response (QR) codes on retail product labels. These enable retailers to manage the supply chain and stocking process, increasing product availability for consumers. Digital banking has disrupted traditional banking models by implementing standardization and common definitions, improving speed, quality and governance of interactions, all translating into a better end-user experience.The ever-increasing complexity of clinical trials impedes efficiency. As in other industries, digital transformation — including digitization, automation and artificial intelligence/machine learning — is improving efficiency, enhancing patient experiences and unlocking crucial insights across healthcare. Electronic scheduling is increasingly available for health-related appointments, with patient portals enabling health information to be self-managed. Integration of AI is making clinical trials more accessible, personalized and transparent, fostering patient-centric trial environments and accelerating development of new therapies.Overall, digital transformation has potential to help clinical trial technologies to be future ready, bringing value to stakeholders from patients and sites to sponsor companies and CROs. Authored by IQVIA experts, this white paper provides a high-level overview of key elements to consider when deploying digital capabilities in clinical trials. Current technology-enabled trends in clinical development include:• Improving decision making, enabling faster, evidence-based decisions• Optimizing R&D and clinical trials, which includes use of digitalization and AI/ML in asset identification, indication prioritization,