The transition from early (phase 1, expansion cohorts and single-arm phase 2) trials to later phases of clinical development poses several challenges. While many of these challenges are of strategic and financial natures, some usual methodological pitfalls can be addressed in a somewhat systematic fashion. In this presentation, we will explore these pitfalls and attempt to outline the key aspects that need to be taken into account to mitigate risks and optimize the chances of successful drug development in oncology, even though the concepts to be discussed are applicable to any other indication where precision medicine is of interest. The most salient issues to be discussed include “regression to the mean” (a key reason why phase 3 results often do not reproduce those from phase 2), the overreliance on historical data, misconceptions about the impact on sample size from randomizing early on, the assessment of more promising subgroups for development of precision therapy in biomarker-defined subsets, and some key aspects related to accelerated approval by the US Food and Drug Administration and conditional marketing authorization by the European Medicines Agency.
During this Good Morning Meeting, clinical experts from IDDI will discuss optimizing the transition from early- to late-phase trials in oncology studies.
Date: Tuesday, 19th of September, 2023
Time: 8:30 – 11:00 CET
Venue: Medicon Valley Alliance (HubNordic) – Auditorium, Arne Jacobsens Allé 13, 2300 Copenhagen S
Program
| 08:30 | Networking, registration, and light breakfast |
| 09:00 | Welcome David Munis Zepernick, Director, Member Engagement & Communication, Medicon Valley Alliance |
| 09:05 | Optimizing the transition from early- to late-phase trials in oncology Everardo D. Saad, MD – Medical Director, IDDI |
| 10:00 | Q&A session |
| 10:30 | Networking |
| 11:00 | End of Good Morning Meeting |
Speaker
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Everardo D. Saad, MD – Medical Director at IDDI Dr. Everardo Saad has nearly 20 years of experience in Medical Oncology and clinical-trial design. He graduated in Medicine and trained in Internal Medicine in Sao Paulo, and did his fellowship in Medical Oncology at the University of Texas M.D. Anderson Cancer Center, in Houston. After practicing for several years, he shifted his professional career towards education and research in Medical Oncology, and has a special interest in clinical trial methodology, the assessment of endpoints, and the development of novel therapies for cancer patients. |
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