Discover an informative webinar delving into how strategic oncology clinical trial design shapes success in early oncology studies using novel approaches. Trial design in early-phase oncology studies has a critical impact on the success of the study. Novel approaches such as biomarker stratification, adaptive enrichment designs, outcome-adaptive randomization and the integration of real-world data have been developed. In addition, under Project Optimus, dose expansion requires the selection of the most appropriate dose and schedule to be brought into the registrational trial, which also needs to be accomplished via dose-finding studies in early-phase trials.
Attendees will learn insights into the trade-offs between protocol design options and offer insight into developing a trial structure that maximizes the chances of success in later phases of research while minimizing risk.
Join this webinar to explore the intricate world of oncology trial design and gain valuable insights to enhance research approaches.
Peter Langecker, MD, PhD, Executive Medical Director, Global Oncology, Caidya
Dr. Peter Langecker, MD, PhD is currently the Executive Medical Director, Global Oncology at Caidya. He has over 25 years of hands-on experience in establishing and conducting industry-sponsored oncology and hematology clinical research and development. His previous positions included pharmaceutical company experience at Novartis, Merck, SUGEN (acquired by Pfizer) and several biotech companies.
Dr. Langecker’s medical training and published research focused on preclinical and clinical oncology and the hormonal regulation of breast cancer. He has had university hospital-level clinical experience in solid tumors (including breast, GI, lung cancer), lymphomas and leukemias and bone marrow transplants. He has authored and co-authored 50+ publications and posters.
Who Should Attend?
This webinar will appeal to professionals with the following titles in the following areas:
- Chief Medical Officers
- Chief Scientific Officers
- Clinical operations
- Clinical development
- Clinical research
- Clinical Program/Project Manager
- Clinical Trial Lead
- TA Experts (oncology)
- Therapeutic Area Leads
What You Will Learn
Attendees will gain insights into:
- How trial design influences early oncology study success and how it can impact later phases of research
- Biomarker stratification, adaptive enrichment and real-world data integration for enhanced outcomes
- The importance of selecting optimal doses and schedules via dose-finding studies for successful registrational trials, minimizing risks in later research phases
- The latest trial design strategies and understand their potential to enhance trial outcomes
- The trade-offs involved in different protocol design options and discover how to develop a trial structure that optimizes the chances of success in later phases, providing valuable knowledge on mitigating risks in early phase trials
Caidya is a multi-therapeutic clinical research organization (CRO) serving innovators worldwide. Focused on delivery excellence and an elevated customer experience, Caidya offers a wide range of clinical services and vast therapeutic expertise, supporting its partners from pre-IND strategy, through clinical development to submission and post-marketing surveillance. Caidya leverages industry-leading and proprietary clinical technology to ensure trial transparency and data-driven decision-making. Formed in 2021 following the combination of leading CROs, dMed and Clinipace, Caidya has over 1,500 employees in more than 20 countries throughout the world.