Lecture series on Key Statistical Methods for Clinical Trials of Medical Devices
This new seminar series is hosted jointly by Harvard Medical School and the Harvard Clinical Research Institute (HCRI). The content of the talks will focus on statistical methods that are currently used in medical device trials, or that are used in other types of trials (e.g., pharmaceuticals) but that may be adapted to medical devices in the near future. The seminars will be held every 4th Tuesday of the month from 4:00-5:30 p.m. at the Conference Center at Harvard Medical School in Boston. The objective of the series is to provide participants with a local seminar series with access to thought leaders in statistics and their current research. The target audience for the series includes academic and industry statisticians, biostatisticians, clinical trial researchers with quantitative backgrounds, and students interested in applied statistics, biostatistics, or trials of medical devices. With the exception of the October seminar, whose venue is still to be determined, all seminars will take place at the Conference Center in either the HIM room or Room 217, a second-floor classroom. If you have any questions about the seminar series or would like to be included on the mailing list, please contact James O’Malley.
- 2007 LECTURES -
Date: November 27, 2007
Speaker: Ralph D’Agostino, Mathematics and Statistics Department, Boston University
Topic: Reviewing and Dealing with Recent Issues in Clinical Trials: The Changing Face of What We Do and Worry About
Abstract: In this talk I will discuss issues that have become major over the recent years (some taking center stage, at least for a while) especially in my activities as an academic consultant. Topics such as composite endpoints for dealing with multiplicity, turning points in time to events studies, the need and spread of adaptive designs and the rise of safety studies will be covered. I will discuss why they arise, the complications that accompany them, and my views on them and their future.
Location: Room 216, Harvard Medical School Conference Center (see link to directions above)
A reception will precede the seminar at 3:45 p.m. Please e-mail pattra.wirojratana@hcri.harvard.edu if you plan on attending the seminar (by Monday November 26, if possible).
Date: September 25, 2007
Speaker: L. J. Wei, Department of Biostatistics, Harvard School of Public Health
Topic: Adaptive Designs via Data Monitoring for Clinical Studies
Abstract: This talk consists of three parts. The first part briefly summarizes the important components of typical clinical trials. The second part presents response-adaptive designs with real and simulated examples to show how feasible such designs would be in practice. The third part is trying to convince clinical trial investigators to utilize a more “quantitative” way (beyond p-value) for designing, monitoring, and analyzing clinical studies. Moreover, we discuss important/interesting issues beyond the simple comparisons (on the average sense) between comparative arms in clinical trials.
Location: HIM Room, Harvard Medical School Conference Center (see link to directions above)
A reception will follow the seminar at 5:30pm. Please send an email to pattra.wirojratana@hcri.harvard.edu if you plan on attending the seminar (by Monday September 24 if possible).
Date: February 27, 2007, 4:00–5:30 p.m.
Speaker: Sharon-Lise T. Normand, Professor of Health Care Policy (Biostatistics), Department of Health Care Policy, Harvard Medical School; Professor of Biostatistics, Department of Biostatistics, Harvard School of Public Health
Topic: “Multivariate Analysis of Mixed Outcomes”
Location: HIM room at the Harvard Medical School Conference Center, 77 Avenue Louis Pasteur (across the street from Boston Latin School)
If you are interested in attending the seminar, please contact Pattra Wirojratana. A short reception will follow the seminar.
Date: March 27, 2007, 4:00–5:30 p.m.
Speaker: Recai Yucel, University of Massachusetts, Amherst
Topic: "Missing Data, Multiple Imputation, and Associated Software" (click here for abstract)
Location: Room 217
Date: April 24, 2007, 4:00–5:30 p.m.
Speaker: Joseph Massaro, PhD, Assistant Professor of Biostatistics, Mathematics, and Statistics, Boston University
Topic: "Propensity Score Adjustment to Account for Lack of Balance of Baseline Characteristics in Non-Randomized Clinical Trials"
Location: Room 217
If you are interested in attending the seminar, please contact Pattra Wirojratana. A short reception will follow the seminar.
Date: May 22, 2007, 4:00–5:30 p.m.
Speaker: Peter Mueller, PhD, Professor Department of Biostatistics, University of Texas MD Anderson Cancer Center
Topic: "Bayesian Decision Theoretic Dose Finding: A Principled Decision Theoretic Approach to Dose Finding, Including Simulation Based Sequential Design" (click here for abstract)
Location: Room 217
If you are interested in attending the seminar, please contact Pattra Wirojratana. A short reception will follow the seminar.
Date: June 26, 2007, 4:00–5:30 p.m.
Speaker: Joel Greenhouse, Carnegie Mellon University
Location: HIM
Date: July 24, 2007, 4:00–5:30 p.m.
Speaker: Don Hedecker, University of Illinois, Chicago
Location: HIM
Date: August 28, 2007, 4:00–5:30 p.m.
Speaker: James O’Malley, Associate Professor of Statistics, Department of Health Care Policy, Harvard Medical School
Location: Room 217
Date: September 25, 2007, 4:00–5:30 p.m.
Speaker: LJ Wei, Harvard School of Public Health
Location: HIM
Date: October 23, 2007, 4:00–5:30 p.m.
Speaker: Alan Sampson, University of Pittsburgh
Location: Other
Date: November 27, 2007, 4:00–5:30 p.m.
Speaker: Ralph D’Agostino, Boston University and HCRI
Location: Room 217
