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- Real World Evidence Insights
Real World Evidence Insights
AI Drives Advances in Drug Development with Real-World and Regulatory Synergy
Latest ResearchAI Drives Advances in Drug Development with Real-World and Regulatory SynergyAI-enhanced real-world evidence (RWE) is revolutionising drug development and regulatory compliance by transforming unstructured data from electronic health records into regulatory-grade insights. The FDA and EMA's recent regulatory guidance underscores the critical role of real-world data (RWD) in expediting drug approvals and refining postmarket surveillance. This shift is particularly advantageous in specialties like ophthalmology, where traditional trials may face limitations. RWD platforms such as the IRIS Registry enable the collection of rich, diverse patient outcomes, bolstering the real-world evidence necessary for informed regulatory decisions and enhancing the relevance of clinical research. AI Revolutionises Oncology with Real-World Evidence UtilisationFlatiron Health's pivotal advancements in real-world evidence (RWE) within oncology signify a leap from hypothetical to actionable insights, fuelled by cutting-edge AI. Spearheaded by Blythe Adamson, Flatiron harnesses AI's capabilities to expedite data extraction from patient charts, reshaping oncology research and clinical care. By merging traditional NLP with generative AI, the company effectively converts unstructured data into regulatory-quality evidence, thus refining decision-making processes in drug development. In tackling the inherent uncertainties of drug research, this approach facilitates faster therapeutic advancements, a critical consideration for industry professionals. Real-World Evidence Shifts Paradigms in Breast Cancer Therapeutic DevelopmentScaling real-world evidence (RWE) is a powerful tool in advancing breast cancer research, addressing the complex landscape of treatment challenges and advancements. Key insights from recent studies reveal how RWE contributes to understanding the efficacy of treatments and patient safety nuances. For example, the analysis of first-line CDK 4/6 inhibitors with aromatase inhibitors demonstrated no significant survival variation, contrary to prior RCT conclusions. This highlights RWE’s role in providing nuanced perspectives that can influence clinical decisions. Real-World Treatment Trends for Prostate Cancer Show Increase in Combination TherapyThe study chronicles the shift in treatment modalities for metastatic hormone-sensitive prostate cancer in the U.S., documenting a significant increase in the use of combination therapies involving androgen-deprivation therapy (ADT) and androgen receptor pathway inhibitors (ARPI), or with additional docetaxel (DOC), from 2017 to 2023. A fascinating trend is seen, where the reliance on ADT solo has waned considerably, shrinking from 74% of treatments in 2017 to 36% by 2023. A stark rise in prescriptions for ADT combined with ARPI, and ADT + ARPI + DOC, marks a 47% and 15% adoption rate, respectively, by 2023. |