Spring 2015 Chapter Meeting of the Kansas-Western Missouri Chapter of the ASA

When:  Apr 2, 2015 from 18:00 to 20:30 (CT)

Dear Members of the Kansas-Western Missouri Chapter of the ASA,

Please join us for our spring Chapter meeting on Thursday, April 2th, 2015 at Kansas State University. The meeting will be held in the Holiday Inn of Manhattan. A map is provided below for your convenience.

Professor KyungMann Kim from the Department of Biostatistics and Medical Informatics at the University of Wisconsin-Madison will be presenting the Keynote Address “Drug Safety and Vioxx® Controversy”. Professor Kim will also present a seminar talk at Department of Statistics at Kansas State University on “Career Opportunities in Biostatistics and Statistical Consulting/Collaboration” at 4:00pm, Dickens 207. Additional information about his talks is listed below.

Please contact our Chapter president, Jo Wick (jwick@kumc.edu) or Chapter secretary Wei-Wen Hsu (wwhsu@ksu.edu) if you have any questions.

 

We look forward to seeing you in Manhattan!

 

Registration

The cost to attend the chapter meeting is $30.00 ($20.00 for students), which includes dinner.

 

The on-line registration time frame is

Registration Starts:

March 1, 2015

Registration Ends:

Apr 01, 2015

Registration for this event can be done online at

https://www.123signup.com/register?id=yyvjv

More information about this event:

https://www.123signup.com/event?id=yyvjv

 

 

Agenda

6:00 – 6:15 p.m. Social time
6:15 – 6:30 p.m. The induction ceremony for Mu Sigma Rho Honor Society
6:30 – 7:15 p.m. Dinner
7:15 – 7:30 p.m. Chapter business
7:30 – 8:30 p.m. Keynote Address

 

Chapter Meeting Keynote Address

Title: Drug Safety and Vioxx® Controversy    

Abstract:  Recently there have been a number of drug safety concerns involving, for example, cyclooxygenase-2 (COX2) inhibitors such as Vioxx® (rofecoxib) and Celebrex® (celecoxib), erythropoiesis-stimulating agents such as Aranesp® (darbepoetin alfa), Epogen® (epoetin alfa) and Procrit® (epoetin alfa), and anti-diabetic drugs such as Avandia® (rosiglitazone maleate). Celebrex® (celecoxib) and Vioxx® (rofecoxib) are both a non-steroidal anti-inflammatory drug selectively inhibiting cyclooxygenase-2, an enzyme responsible for inflammation and pain, and were approved by the US Food and Drug Administration in December 1998 for treatment of osteoarthritis and rheumatoid arthritis and May 1999 for treatment of osteoarthritis, acute pain and dysmenorrhea, respectively. The US National Cancer Institute launched the Adenoma Prevention with Celecoxib (APC) trial in November 1999, and shortly thereafter Merck launched the Adenomatous Polyp PRevention On Vioxx (APPROVe) trial in February 2000.  A regularly scheduled review of the interim safety data from the APPROVe trial by its external safety monitoring board led to a voluntary withdrawal of Vioxx® from the market on 30 September 2004, followed by early termination of the APC trial due to safety concern on 17 December 2004 by the NCI. In this review, I will provide the general background on the drug safety issues and illustrate the challenges, with post-marketing trials of COX2 inhibitors as an example.  More specifically, I will review the development of Vioxx®, the events leading up to its voluntary withdrawal by Merck, subsequent publications about cardiovascular adverse events for the APPROVe and APC trials, and surrounding controversy, with liability litigations in the background. I will attempt to draw lessons in terms of clinical trials design, conduct, monitoring, analysis and publication. In particular, I will highlight the controversy surrounding the analysis of cardiovascular events and the interpretation of emerging difference in the Kaplan-Meier estimates from the APPROVe trial.

 

Additional Information

Additional statistical talk will be given by Professor KyungMann Kim at the Department of Statistics, Kansas State University on April 2th from 4:00 – 5:00 p.m.

 

Title: Career Opportunities in Biostatistics and Statistical Consulting/Collaboration

 

Abstract:  Thanks to the fact that the US has an advanced, post-industrialized, service-oriented economy, health care and research has become a very important component of industry as well as government-driven research and service.  Biostatistics plays a critical role as research methodology in many areas of biomedical health research.  In this presentation geared toward graduate students in statistics, I will describe career opportunities in biostatistics and share my own experience in statistical consulting and collaboration.  I will also present statistical methods for panel count data that arose out of statistical collaborative research, one on joint modeling of panel count data with longitudinal biomarkers and the other on models for bivariate panel count data.

  

Biographical sketch of Professor KyungMann Kim:

KyungMann Kim, PhD

Professor of Biostatistics and Statistics

Department of Biostatistics and Medical Informatics

University of Wisconsin-Madison, Madison, WI, USA

  

A graduate of the University of Wisconsin-Madison with a degree in Statistics, Dr. Kim was Assistant and Associate Professor of Biostatistics at Harvard School of Public Health and Dana-Farber Cancer Institute, Associate Professor of Biostatistics at the University of Michigan School of Public Health, and Visiting Associate Professor of Ophthalmology at Johns Hopkins University. He has sat on advisory panels and data monitoring committees for the National Institutes of Health, Department of Veterans Affairs, Department of Defense, and the Environmental Protection Agency and for biopharmaceutical and device industry, in addition to professional services to the American Statistical Association, the Society for Clinical trials, the International Biometric Society, and the International Society for Clinical Biostatistics. He is an elected Fellow of the American Statistical Association (2005), the American Association for the Advancement of Science (2012) and the Society for Clinical Trials (2012) for contributions in statistical science and clinical trials methodology, professional services to government, industry and professional organizations, and leadership role at the national and international level.  His area of statistical research includes sequential methods and interim analysis, clustered data analysis including analysis of panel count data, and methods for clinical trials, and his collaborative research has been primarily in clinical, basic and translational research in cancer and clinical research in HIV/AIDS, autoimmune diseases, cardiovascular diseases, migraine, infectious diseases, hematology, endocrinology, lysosomal storage disease, osteoporosis and osteoarthritis, allergy and respiratory disease, obesity, and geriatrics.

https://www.biostat.wisc.edu/content/kim-kyungmann

 

 Chapter Meeting Address:

 

Landon Room

Holiday Inn Manhattan at Campus

(The intersection of N17th Street and Anderson Avenue)

 

 

Location

Holiday Inn Manhattan at the Campus
1641 Anderson Avenue
Manhattan, KS 66502

Contact

Wei-Wen Hsu
785-532-3585
wwhsu@k-state.edu