Reader Challenges in Blinded Independent Central Reviews
Dr. Smalberg describes the role of a blinded independent central reviewer and discusses the challenges and opportunities involved in working with imaging core labs, including evolving workflow practices and imaging criteria.
3 key questions
that are answered:
- What are the fundamentals of Lugano Classification?
- What data collection elements are needed when reading Lugano classification?
- What are the challenges and updated recommendations from industry/academia in Lymphoma reading assessments?
Ira Smalberg, MD
Dr. Smalberg is a radiology expert on quantitative imaging in oncology clinical trials, and is the CEO and founder of Radmetrix, a company that provides physician specialists for blinded independent central reviews for imaging in clinical trials using RECIST 1.1, iRECIST, Cheson, Lugano, Hallek and other imaging criteria. He is a central radiology reviewer for multiple national and international Phase 2 and Phase 3 clinical trials. Dr. Smalberg received his Medical Degree at the UCLA School of Medicine and completed his Residency in Radiology at North Shore University Hospital in Manhasset, NY. He also completed a fellowship in Abdominal Imaging at the New York University School of Medicine.
Seokyeong (Gene) Kim, PharmDCLINICAL SCIENTIST
Gene is a Clinical Scientist providing subject matter expertise and helping design and configure MERIT’s flexible oncology reading platform to accommodate various reading paradigms. He has experience in evidence-based patient care and academic research, a background in pharmacy, and 6 years supporting clinical trials. Gene implements software workflows to support oncology trials with response criteria such as RECIST 1.1, iRECIST, Lugano, and RANO, and helps to increase the efficiency and accuracy of clinical data collection for imaging endpoints. He received his Doctor of Pharmacy (Pharm.D.) from the University of Wisconsin-Madison and has a bachelor’s degree in Neurobiology.