艾昆玮-利用真实世界的证据支持肿瘤靶向治疗（英）

White PaperLeveraging Real World Evidence to Support Oncology Targeted Therapies Table of contentsExecutive summary 3Introduction: Real World Evidence (RWE) for precision oncology 4Challenge: RWE with novel biomarkers 5Solution 1: Access to linked biomarker & clinical data 6Solution 2: Retrospective testing of archival tissues 7Solution 3: Enabling AI-Powered precision oncology 8Conclusion 9About the author 9References 10 iqvia.com | 3Our white paper provides an overview of a comprehensive solution for generating Real World Evidence (RWE) in the field of precision oncology.Oncology targeted therapies can significantly benefit from RWE programs, speeding up clinical development, supporting market access, and driving market penetration.However, the adoption of novel biomarkers in clinical practice is slow. This, combined with the variability in testing practices and the low prevalence of some novel biomarkers, makes RWE programs unpredictable, costly and even unfeasible in certain cases.Our team has developed a comprehensive solution to increase the feasibility and maximize the value of RWE programs for targeted cancer therapies, including:• Access to linked biomarker & clinical data: By partnering with leading oncology centers in Europe, this solution combines rich biomarker data with clinical Electronic Medical Record (EMR) data. It enables various types of RWE studies and enhances efficient site selection, expediting evidence generation and market access.• Retrospective testing of archival tissues: Collaboration with biobanks and pathology labs allows for retrospective testing of archival tissue samples, broadening our understanding of novel and under-tested biomarkers. This efficient and cost-effective approach speeds up precision oncology studies.• Enabling AI-Powered precision oncology: This solution streamlines access to imaging and pathology data for pharmaceutical partners. Whether for detecting oncology biomarkers from pathology images or discovering radiomics-based biomarkers, these data modalities are key for leveraging machine-learning technologies.Our dedicated solution enables us to run effective RWE programs for targeted cancer therapies, even for novel and under-tested biomarkers, and helps our pharmaceutical partners get the most value from these programs.Executive summaryIQVIA's Oncology Evidence Network (OEN) collaborates with academic hospitals and cancer centers to produce significant real-world evidence studies in oncology. With more than 30 partners, OEN has enabled many RWE studies across a broad range of oncology indications, including natural history, comparative effectiveness, external comparator, and precision oncology studies.4 | Leveraging Real World Evidence to Support Oncology Targeted TherapiesIntroduction: Real World Evidence (RWE) for precision oncologyTargeted therapies are instrumental in revolutionizing cancer treatment, as they provide personalized care to each patient. Products that necessitate biomarker