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Biostatistics & Medical Informatics
Clinical Trials Program Seminars
Brown Bag Discussion Series


Anyone with an interest in Clinical Trials is welcome to attend!

Clinical Trials Brown Bag Discussions are usually held on the first Wednesday of every month, from 12-1 p.m. in room 234 WARF (Red Table Room). Please check this site for topics of future seminars as they become available.

Academic Year 2013-2014
Feb 5 2014 Presenter/Facilitator: Weiqun Tong - Everolimus: A mTOR Inhibitor for Treatment of Breast Cancer
Jan 8 2014 Presenter/Facilitator: Tom Cook - Adaptive Trials from 30,000 Feet
Dec 4 2013 Presenter/Facilitator: Marian Fisher - 2013 ACC/AHA Guideline on the Treatment of Blood Cholesterol to Reduce Atherosclerotic Cardiovascular Risk in Adults: Context and Controversy
Oct 2 2013 Presenter/Facilitator: Robin Bechhofer - Issues from the FDA Advisory Committee Meeting to Review the New Drug Application (NDA) for the use of Tovaptan to Treat Autosomal Dominant Polycystic Kidney Disease (ADPKD)
Academic Year 2012-2013
Apr 3 2013 Speaker:Melissa Schultz - The Reduction of Events with Darbepoetin alfa in Heart Failure (RED-HF) Trial: Overview and Results
Mar 19 2013 Speaker:Allison Furey - Placebo Effects
Jan 23 2013 Speaker:Gabriel Nicholas - Recent developments in Rheumatoid Arthritis
Academic Year 2011-2012
Dec 05 2012 Speaker:Scot Diegel - Major Depressive Disorder (in Children and Adolescence), Overview of the Pristiq Phase III Pediatric Trials
Nov 14 2012 Speaker:Brian Traver - Topics from the 2012 Sensible Guidelines Symposium.
Oct 3 2012 Speaker:Marian Fisher - ATLAS Challenge: Missing Data & Questionable Quality.
May 2 2012 Speaker:Shuang Huang - Introduction to Item Response Theory Modeling with Application to a Study of Alcohol and Marijuana Dependences.
Apr 11 2012 Speaker:Kathryn Schurr - Osteoporosis Clinical Trials with Fracture Outcomes
Mar 17 2012 Speaker:Weiqun Tong - Introduction to Pharmacokinetic Data
Feb 1, 2012 **Cancelled**
Jan 11, 2012 Speaker: John Kloke - Systematic Review and Meta-analyses
Dec 7, 2011 Speaker: Tom Cook - From the SDAC Archives: The WIZARD Trial
Nov 2, 2011 Speaker: Allison Furey - JAK Kinase Inhibitors: Disease Areas Targeted and Issues Surrounding Selectivity
Oct 5, 2011 Speaker: Robin Bechhofer - Recent Trials of Novel Anticoagulants in Atrial Fibrillation
Sept 14, 2011 Speaker: Melissa Schultz - Teplizumab for Treatment of Type 1 Diabetes: Results of the Protege Study
Academic Year 2010-2011
May 4, 2011 Speaker: Jan Feyzi
April 6, 2011 Speaker: Gabriel Nicholas
March 2, 2011 **Cancelled** - Speaker: Michelle Detry
Feb 9, 2011 Speaker: Scott Diegel - Reproducible Research: Some Issues and Possible Solutions
Dec 1, 2010 Speaker: Kevin Buhr - The Ethics of Placebo-Controlled Trials
Nov 9, 2010
Speaker: Brian Traver - An Overview of CDISC (Clinical Data Interchange Standards Consortium)
Nov 3, 2010 Speaker: Tom Cook (continuing his presentation from October)
Oct 13, 2010 Speaker: Tom Cook - From the SDAC Archives: Some Issues Associated with the ACTS and THS Trials
Sept 8, 2010 Marian Fisher - Wisdom from Wittes: "Missing Inaction," "On Looking at Subgroups"
Academic Year 2009-2010
May 10, 2010 Deedra Nicolet - Background for PEARL Trial Overview of Schizophrenia and Bipolar Disorder
April 7, 2010 Allison Furey - Tolvaptan: A Survey of Potentially Treatable Diseases and Associated Clinical Trials
March 3, 2010 Melissa Schultz - Current Approaches to Therapy for Type 1 Diabetes
Feb 3, 2010 Robin Bechhofer - Issues in Clinical Trails Data Monitoring

*Please note: Attendees will be encouraged to share examples and experiences based on trials in the SDAC portfolio.
Jan 6, 2010 Jan Feyzi - CORONA: The Final Year

*Please note: Results of the trial will not be presented in detail; however, you may want to review the primary manuscript for background information. Detailed Trial Results
Dec 2, 2009 Gabriel Nicholas - FDA Reviewer Guidance: "Conducting a Clinical Safety Review of a New Product Application and Preparing a Report on the Review"
Nov 4, 2009 Michelle Detry - Adaptive Randomization: An Overview of the Pros and Cons
Oct 7, 2009 Scott Deigel - Medical Coding and Classification Systems for Clinical Trials: A High Level Overview
Academic Year 2008-2009
Jan 7, 2009 Septmeber 2008 example of "Who Knows What and When?"
Feb 4, 2009 Some Comments on Causality
March 25, 2009 Results of the ILLUMINATE Trial
April 8, 2009 The Reduction of Events with Darbepoetin alfa in Heart Failure (RED-HF) Trial: "Rationale, Design and Challenges"
May 9, 2009 A Prospective, Randomized Trial Comparing the Efficacy of Anidulafungin and Voriconazole in Combination to that of Voriconazole Alone When Used for Primary Therapy of Proven or Proabable Invasive Aspergillosis
Academic Year 2007-2008
Oct 3 Scott Diegel
Nov 7 Ellen Roecker - Clinical Trialists' Journey to the Last Frontier
Dec 5  Michelle Detry
Feb 11
Robin Bechhofer - Patient-Reported Outcome Measures: Selected Regulatory Issues
Mar 5  Jan Feyzi
Apr 2  Marian Fisher
May 7  Melissa Schultz
Academic Year 2006-2007
Dec 13 Anti CD3 Monoclonal Antibody in New-onset Type I Diabetes
Feb 7

A 1-year Extension to the Adenomatous Polyp Prevention on Vioxx (APPROVe) Trial

April 18

CB1 Inhibition in the Treatment of Obesity


Academic Year 2005-2006

May 10
The Rationale and Design of the Trial to Reduce Cardiovascular
Events with Aranesp Therapy (TREAT Trial)
March 1
The Search for an Association between Statins and Cancer Risk
Feb 1
Combining Information across Studies: Methods, Pitfalls, and Limitations
Dec 7
FDA Advisory Meeting (Arthritis Committee, Drug Safety and Cancer Risk Management Committee): February 16-18, 2005
Nov 2
The Studies of Oral Enozimone Therapy in Advanced Heart Failure (ESSENTIAL):
Design and Final Results
Oct 5
Advanced Issues in the Design and Conduct of Randomised  Clinical Trials-
A Discussion of the Oxford International Symposium


Academic Year 2004-2005

May 18

Tolvaptan in Patients with Congestive Heart Failure:
Background and Design of the Everest Trial

April 6 The TNT (Titrating to New Targets) Study: ACC Presentation
and Review of the Monitoring Process
March 16 Basic Issues in Gene Therapy
Dec 1 Liability in the Data Monitoring Process
Nov 3 Clinical Trials in Pulmonary Arterial Hypertension
Oct 6 The Comparison of Medical therapy, Pacing, ANd defibrillatION in
heart failure (COMPANION) Trial: Final Results and FDA Review


Academic Year 2002-2003

May 9

Title: Celecoxib, a COX-2 Inhibitor, in Cancer Prevention

April 9 Title: The Carvedilol Post-Infarct Survival Control in LV Dysfunction (CAPRICORN) Trial
March 5 'The Age-Related Eye Disease Study (AREDS)'
Feb 5 Results of the ALLHAT Trial'
Dec 4, 2002 'Discussion of Results from the Women's Health Initiative Estrogen Plus Progestin Trial'
Nov 6, 2002 'Cholesterol Lowering with Statins: Effect on Cardiovascular Disease'
Oct 2 'Precursor Studies of ADOPT (A Diabetes Outcome Progression Trial)'


Academic Year 2001-2002

May 1

Results of the Endothelin Antagonism with Bosentan and Lowering of Events (ENABLE) Trial

April 3 The WIZARD Trial
March 6 The Val-HEFT Trial: Angiotensin-Receptor Blockade in Congestive Heart Failure
Feb 6 Managing and Monitoring Multicenter Clinical Trials: Who is in charge of what?
Jan 9 FDA Draft Guidance for Clinical Trial Sponsors On the Establishment and Operation of Clinical Trial Data Monitoring Committees
Dec 5 Pacemakers, Defibrillators and the Companion Trial
Nov 7 Paradoxes in Equivalence Trials
Oct 10 Stroke Prevention in Patients with Atrial Fibrillation


Academic Year 2000-2001

May 2


April 4 "Uninformed Consent: What Patients at the 'Hutch' Weren't Told About Experiments in Which They Died"
Feb 14 The Sharing of Information Between Data Safety Monitoring Boards.
Jan 10 A Brief Overview of 30 Years of Experience with Cholesterol-Lowering Trials. Part III.
Nov 1 A Brief Overview of 30 Years of Experience with Cholesterol-Lowering Trials. Part II.
Oct 11 A Brief Overview of 30 Years of Experience with Cholesterol-Lowering Trials. Part I.
Sept 6 A Carvedilol Update: Mortality Results of the COPERNICUS Trial


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