Drug development in oncology is accelerating at an ever faster pace due to an increasing availability of agents and combinations that need to be assessed in clinical trials. As a result of this fast pace, the choice of endpoints for clinical trials is becoming more critical than ever before. Overall survival, the historical endpoint of choice in phase III, is progressively less suitable as primary endpoint, especially due to the time and resources that are necessary to reliably assess it, and also because of the increasing availability of salvage therapies that confound the effect of treatment on survival. These drawbacks of overall survival set the stage for surrogates like disease-free survival and progression-free survival, which are used with the goal of expediting clinical research. However, there has been a recurrent concern that some of these endpoints have not been properly validated as surrogates for survival.
In this webinar, the speakers will provide an overview of the current status of surrogates for overall survival in oncology. We will start by reviewing the pros and cons of the various efficacy endpoints currently used. We will then briefly discuss the currently preferred method for validation of surrogate endpoints, after which we will present an overview of the various settings in which disease-free survival and progression-free survival have or have not been considered a valid surrogate for survival. We will illustrate our presentation with several examples, including the evolution of surrogacy within a given setting and potential differences between treatment classes, including immune checkpoint inhibitors.
Marc Buyse, ScD, Chief Scientific Officer, International Drug Development Institute (IDDI)
Marc Buyse holds a ScD in biostatistics from the Harvard School of Public Health (Boston, MA). He is the founder of the International Drug Development Institute (IDDI) and of CluePoints, two biostatistical service organizations based in the US and Europe. He is interested in clinical trial design, meta-analysis, validation of biomarkers and surrogate endpoints, statistical methods in oncology, statistical detection of errors and fraud, statistical monitoring of clinical trials, and medical data sharing (http://publicationslist.org/marc.buyse).
Dr. Everardo Saad, Senior Medical Expert, IDDI
Dr. Saad, IDDI’s Senior Medical Expert, has over 15 years of experience in Medical Oncology and clinical trial designs. 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 trialists, statisticians, physicians, and other professionals involved in the design, conduct and analysis of clinical trials in oncology.
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).