演讲PPT-2025年度临床试验综述-创新监管与可持续（英）

C I T E L I N E . C O M2025 Edition: Innovation, Regulation, and PreservationThe Annual Clinical Trials RoundupHeidi Chen, PhDAssociate Director, Research & Commercial Services Total trial initiations and Y-O-Y trends Clinical trials by therapeutic areas Top 10 diseases Rare disease trials Top industry sponsors Geographic distributions Concluding thoughtsAgenda2024 Clinical Trial Initiations by the numbersGrowth in industry-sponsored (67%) trials significantly declined• Tightening capital markets and focus shift• Increased trial costs – complex protocols• Evolving diversity requirements• Global harmonization challenges• Political conflicts – supply chain disruption; patient/site displacementScope of trial analysisPhase I-III, disclosed initiation date in 2024, Trialtrove curated trialsPhase I-III trials by therapeutic areaOncology (37%) remains a core area of research•Immunotherapy, T-cell therapies, antibody-drug conjugates (ADCs) & bispecifics•RadiopharmaceuticalsCNS grew by 14.7%•Pain, depression, Alzheimer’s diseaseAutoimmune/Inflammation (A/I)•Impressive growth of 14.6%•Cell therapy, i.e. CAR-T expansion beyond oncologyIndustry-sponsored Phase I-III trials by TAIndustry sponsored trials by therapeutic areaOncology (30% share) had the most trials but declined by 5% in 2024Autoimmune/Inflammation grew by 17%, second largest TA for pharma industry; CNS sustains its growing presence at 15.5%Infectious disease grew by 22%. Cardiovascular and metabolic experienced modest decline but remain a strong focus area for the industryTrial distribution by phase and TA•Phase II growth by 14.3%•Phase III share grew from 2.7% to 15.4%•Even TA distributions in Phase I and III•Oncology is the clear winner in Phase II developmentTop 10 diseases in 2024 trial initiationsTop 10 diseases and their rankingsAll trialsDisease# of trialsRank (2023 rank)Non-Small Cell Lung Cancer5891 (1)Breast Cancer4582 (3)Respiratory Infections4183 (4)Type 2 Diabetes4134 (2)Colorectal Cancer3635 (5)Non-Hodgkin's Lymphoma3486 (6)Hypertension3297 (8)Pain (nociceptive)2998 (10)Esophageal Cancer2969 (12)Obesity26510 (24)Disease# of trialsRank (2023 rank)Non-Small Cell Lung Cancer4041 (1)Type 2 Diabetes3622 (2)Respiratory Infections3373 (3)Hypertension3044 (5)Breast Cancer2875 (4)Obesity2226 (21)Colorectal Cancer2167 (7)Dyslipidemia1938 (12)Non-Hodgkin's Lymphoma1839 (6)Pancreatic Cancer17310 (9)Industry-sponsored trials•Diseases with most Phase I trials: T2D, hypertension, respiratory infection•Esophageal cancer entered top 10 – rare disease development•Obesity made the list, riding on the success of GLP-1 boom•Phase III blue ribbons: NSCLC, respiratory infections, breast cancer, pain (nociceptive).•New comers: pancreatic cancer, dyslipidemia•Biggest leap: obesity: from #21 in 2023 to #6Rare Disease Trials•52% novel drugs approved by the FDA are for rare diseases•Rare disease drugs: 7,721 in 2025, 32.3% share of pipeline•Trial sponsorship split between industry (48%) and academic (