This webinar will discuss adaptive designs for phase I, phase II and phase III clinical trials in oncology. The webinar will take the form of a debate between two statisticians trying to meet the requirements of an oncologist. The pros and cons of various adaptive designs will be discussed. Topics will include continual reassessment methods for phase I trials, adaptive Bayesian designs for phase III trials, adaptive sample size increases and adaptive enrichment of phase III trials.
Marc Buyse, Sc.D, Founder and Chairman, IDDI
Marc Buyse holds a doctorate degree in biostatistics from the Harvard School of Public Health (USA). He is the founder of the International Drug Development Institute (IDDI) and of CluePoints, and an Associate Professor of biostatistics at Hasselt University in Belgium. He has published extensively on cancer clinical trials.
Tomasz Burzykowski, PhD, VP of Research, IDDI
Tomasz Burzykowski has been working as Research Professor of Biostatistics/Bioinformatics at the Center for Statistics of Hasselt University since 2002.
He held a visiting professorship position at the Department of Medical Epidemiology and Biostatistics at the Karolinska Institute (Sweden). In 2009, he joined IDDI as Director of Research. Tomasz has published methodological papers on topics like surrogate endpoint validation, meta-analysis, missing data, and survival analysis. He has also published articles on applications of statistics in various areas of clinical medicine including oncology, dermatology, or orthodontics. He has been involved in interdisciplinary research in numerous biomedical studies and clinical trials. He serves as Associate Editor for Biometrics.
Everardo Saad, MD, Scientific Director and Chairman, Dendrix, Senior Oncology Consultant, IDDI
Everardo D. Saad is the scientific director and chair at DENDRIX, a medical education, communications and research company based in Sao Paulo, Brazil. 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.
Who Should Attend?
Clinical investigators, medical coordinators, pharmacologists, translational researchers, and statisticians involved in the design of adaptive clinical trials in:
- pharmaceutical companies
- biotechnology firms
- academic research institutions
International Drug Development Institute (IDDI) is an expert center in biostatistical and integrated eClinical services for Pharmaceutical and biotechnology companies in several disease areas, including oncology and ophthalmology.
IDDI optimizes the clinical development of drugs, biologics and devices thanks to proven statistical expertise and operational excellence. Founded in 1991, IDDI has offices in Belgium, Boston (MA), Raleigh (NC) and San Francisco (CA).
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