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Talks focused on translating recent advances in biostatistics into practice. Biostatistics Continuing Education
At a glance
Opportunity for
  • Continuing education on recent advances in biostatistics
Eligibility
  • All members of the Harvard Catalyst community, but primarily geared toward biostatisticians
Session Dates
  • Varies; see below for details

The Harvard Catalyst Biostatistics Program presents seminars on current applied topics in biostatistics. These include monthly journal club and work in progress sessions, seminar series, symposia, and short courses.

Journal Club/Work in Progress


Seminar Series


Symposia


Short Courses

Some Key Concepts in Design and Analysis of Early Developmental Clinical Trials

January 15, 2019, 9:00am-5:00pm
FXB G13, Harvard T.H. Chan School of Public Health

This course will cover basic principles underlying translational trials and dose-finding methods. Translational clinical trials (which might be viewed technically as pre-developmental) are often nested in later developmental studies. They rely on established biological models of disease, treatment mechanism, and efficacy signals. Information gained from them guides subsequent experimental steps but does not alter clinical practice. The course will discuss their role and the formal utility of uncertainty in design and interpretation. Dose-finding methods have historically been of value in cytotoxic drug development, but the same designs have been uncritically applied to many drugs and biologicals, and in current times to immunotherapies. The course will cover the use of the continual reassessment method (CRM) for dose finding. It will also discuss a generalization of the CRM that relaxes most of the required assumptions underlying the cytotoxic model, and therefore might be useful for dose-finding/optimization of immunotherapy agents and other therapies with non-sigmoidal dose-response functions. In addition to these technical topics, a mid-day interlude will discuss some of the historic evolution in clinical trials. There will also be an optional lecture at the end of the day on late developmental failures and pipeline optimization to help illustrate the criticality of well-designed translational trials.

Steven Piantadosi, MD, PhD
Associate Senior Biostatistician, Surgical Oncology, Brigham and Women's Hospital

Please register.


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