Clinical Endpoints and Treatment Effect in Immuno-Oncology

Immuno-oncology is a buoyant field of research with recently developed drugs showing unprecedented response rates and a hope for a meaningful prolongation of the overall survival of some patients.

We will review adaptations to tumor response and progression criteria for immune therapies. Survival may be the endpoint of choice for clinical trials in some tumor types, but presence of delayed treatment effects and non-proportional hazards may complicate evaluation of treatment benefits. We will review statistical methods to best describe and test for treatment effects in immuno-oncology randomized clinical trials.

Speakers

Tomasz Burzykowski, PhD: VP Research at the International Drug Development Institute (IDDI)

Tomasz Burzykowski has been working as a professor of biostatistics at Hasselt University since 2002. He held a visiting professorship position at the Department of Medical Epidemiology and Biostatistics at the Karolinska Institute (Sweden). He has been involved in interdisciplinary research in numerous biomedical studies and clinical trials. He serves as a member of the Executive Committee of the International Society for Clinical Biostatistics.

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Everardo Saad, MD: Medical Director at the International Drug Development Institute (IDDI).

Everardo Saad 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.

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