1、White PaperCombination Therapy Dose Optimization in Oncology Trials Design,modeling,and operational considerations for biotech andpharmaJEFFREY HODGE,MS,Vice President Early Phase Oncology,Hematology-Oncology Center of ExcellenceDAVID ALSADIUS,MD,PhD,Senior Medical Director,Solid Tumor Lead,Hematolo

2、gy-Oncology Center of ExcellenceJENNIFER UNDERWOOD,MSc,Senior Therapeutic Strategy Director,OncologyZHENG LIU,DSc,Director,Quantitative Clinical PharmacologyBRYCE DAVIES,MSc,Head of APAC Strategy,Early Phase Oncology and Innovative TherapiesTable of contentsIntroduction 1The growing role of combinat

3、ion therapies in oncology 2Dose optimization:The shift away from maximum tolerated dose 3Trial design,feasibility,and execution considerations 6Data analysis:Modeling and simulation for decision-making 10Conclusion 11References 12 |1Combination therapies represent the future of oncology innovation,o

4、ffering clinicians with regimens that have the potential to enhance efficacy,delay resistance and improve patients responses and outcomes.Yet,determining dose optimization for such regimens is among the fields most complex challenges and requires rigorous operational and statistical planning and exe

5、cution.This white paper reviews the design,operational,and analytic challenges that sponsors must consider when designing effective and efficient combination dose-finding trials.Sponsors who partner with clinical research organizations like IQVIA can leverage their experience in this setting to real

6、ize precision and efficiencies to advance combination therapies aligned with global regulatory expectations.Introduction2|Combination Therapy Dose Optimization in Oncology TrialsThe growing role of combination therapies in oncology The combination of drugs is now central to modern oncology clinical