Working Group on Clinical Trials

The Working Group on Clinical Trials (WGCT) was established in 1988 as a forum for investigators to present preliminary protocols for proposed studies so that they could obtain useful feedback from their colleagues. Regular attendees of the meetings, which are held approximately twice per month, include members of both the Department of Neurology and the Department of Biostatistics and Computational Biology, many of whom possess a great deal of experience in clinical research. A typical session involves presentation of the scientific background and rationale of a study, leading to a focused discussion of design issues. The atmosphere is informal and discussion is encouraged so that both the speaker and the audience benefit greatly from the meetings.

In addition to preliminary protocols, many other topics are appropriate for discussion at the working group meetings. These include, but are not limited to data management techniques, patient recruitment, rating scale development, reliability of measurement, epidemiologic surveys, ethical issues, grant preparation strategies, trial monitoring, academia/industry relationships in medical research, innovative statistical designs, and presentation of interesting trial updates or results. Occasionally, guest speakers from inside or outside the University are invited to give their perspectives on certain aspects of clinical trials or present their own research. A general goal of the meetings is to promote awareness of the principles of good clinical trial design and management.

Spring 2014 WGCT Meetings

May 9, 2014
Feng (Vankee) Lin, PhD

Neurophysiological Aspects of Vision-Based Speed of Processing Cognitive Training in Older Adults with Mild Cognitive Impairment: Preparation for an R01 Application

 7:45 - 8:45 am

PM&R Conference Room: 5-4121

Jun 20, 2014
Yeates Conwell, MD
Kimberly Van Orden, PhD

The Senior Connection- Trials and Tribulations of Recruitment through Primary Care for a Community-Based RCT

 7:45 - 8:45 am

Garvey Conference Room: 5-5220

Please contact Erika Augustine (erika_augustine@urmc.rochester.edu) for room confirmation or with questions concerning the above schedule.

 

Fall 2013 WGCT Meetings

TIME:  7:45 - 8:45 am
PLACE:  Garvey Room (Med Center 5-5220) unless otherwise noted*

Nov 1, 2013
Frank J. Sasinowski, MS, MPH, JD
FDA Evaluation and Approval of Drugs for Rare Diseases: The Importance of Subpart H

* Please contact Lisa Oppelt at 275-0800 for room confirmation or with questions concerning the above schedule.

 

Spring 2013 WGCT Meetings

Jul 12, 2013
Geoffrey C. Williams , MD, PhD
Robert C. Block, MD, MPH, FACP, FNLA
Enhancing Motivation for Achieving Lipid Goals with Framingham Risk
Jun 21, 2013
Harris A. Gelbard, MD, PhD
Michael C. Keefer, MD
Amneris E. Luque, MD
Giovanni Schifitto, MD, MS
New Opportunities for Research and Treatment of HIV-1 Associated Neurocognitive Disorders (HAND)
May 24, 2013
J. Steven Lamberti, MD
Glycine Transport Inhibitors in Schizophrenia: The Next Big Thing?
May 17, 2013
Nicholas E. Johnson, MD
Designing a Disease Progression Study in Congenital Myotonic Dystrophy
Apr 26, 2013
Jonathan W. Mink, MD, PhD
Task-Specific Focal Embouchure Dystonia in Musicians
Apr 19, 2013
Robert H. Dworkin, PhD
Robert A. Gross, MD, PhD
Michael P. McDermott, PhD
Towards a Taxonomy of Research Mischief and Misconduct
Feb 22, 2013
Erika Augustine, MD
First line treatment for pediatric tic disorders – A comparative effectiveness study
Feb 15, 2013
Kevin Biglan, MD, MPH
STEADYPD3: A Phase 3 Trial of Isradipine in Early Parkinson Disease

Spring 2012 WGCT Meetings

Jan 13, 2012
Jim White, MD, PhD
Goldilox and 3 Doses of Treprostinil
Jan 20, 2012
Annie Killoran, MD
Feasibility of Phase III Clinical Trials in Pre-Manifest Huntington’s Disease
Jan 27, 2012
Nancy Bennett, MD
Comparative Effectiveness of Practice-Based Diabetes Prevention Programs
Feb 17, 2012
Arthur Moss, MD
MADIT-Related Device Trials
Mar 9, 2012
Kevin Biglan, MD, MPH
STEADY3: Overview of a Phase 3 Study of Isradipine in Early Parkinson Disease
Mar 16, 2012
Giovanni Schifitto, MD
Does Chronic Exposure to cART Predispose Older HIV Infected Individuals to CNS Injury?
Mar 23, 2012
Jeffrey Statland, MD
Instrumented Timed Functional Test in FSH Dystrophy
Mar 30, 2012
Karl Kieburtz, MD, MPH
Kathy Wunderle
Appropriate Physician Prescribing: Impact of Industry
Apr 13, 2012
Gary Myers, MD
Designing & Executing the Seychelles Main Cohort Study
Apr 20, 2012
Kate Young, PhD
Adapting a Cost-Effectiveness Analysis to a Moving Target
May 11, 2012
Matt Bellizzi, MD, PhD
Gray Area or a Disconnect in MS Cognitive Impairment: A Clinical Study
May 18, 2012
Yi Zhang, MD
The Feasibility of Hemodynamic Monitoring Microcirculation after Subarachnoid Hemorrhage Using Transcranial Doppler
May 25, 2012
Michael McDermott, PhD
John Langfitt, PhD
ERSET: Snatching Victory from the Jaws of Defeat
Jul 13, 2012
Christopher P. Gallati, MD
Safety and Efficacy of Stellate Ganglion Block in the Treatment of Acute Ischemic Stroke

Fall 2011 WGCT Meetings

Oct 21, 2011
Yeates Conwell, MD
The Senior Connection: An RCT of peer support to reduce risk for suicide
Nov 11, 2011
David Herrmann, MB BCh
Proposal for a Treatment Trial for Muscle Cramps in Charcot Marie Tooth Disease
Nov 18, 2011
Amy-Lee Bredlau, MD, FAAP
A phase II study of Ketamine in children
Dec 9, 2011
Charles Venuto, PharmD
Quantifying Huntington's Disease Progression: A Pharmacometrics Approach

Spring 2011 WGCT Meetings

Feb 18, 2011
Rabi Tawil, MD
Optimizing Clinical Outcome Measures in FSH Muscular Dystrophy
Mar 18, 2011
Eric Rubinstein, JD, MPH and Lauren Farberman, MBA
CTSI Research Navigator Program: a full service research help desk
May 20, 2011
Curtis Benesch, MD, MPH
City-Wide Stroke Care: Raising the Bar or Quasi-Experiment?
May 27, 2011
Ronald M. Epstein, MD
A mindful communication intervention to improve quality of care, quality of caring and well-being
Jun 17, 2011
Anthony Pietropaoli , MD
Sodium nitrite therapy in severe sepsis: a novel intervention targeting microvascular blood flow

Fall 2010 WGCT Meetings

Sept 17, 2010
James Cloyd, PharmD
Challenges in developing intravenous topiramate for neonatal seizures
Sept 24, 2010
Robert Holloway, MD, MPH
Conflicts of interest: the perils and promise of transparency
Oct 22, 2010
Robert Gross, MD, PhD
Publishing trials: the editorial perspective
Nov 5, 2010
Mark Mapstone, PhD
Optimizing Deep Brain Stimulation for Parkinson's Disease
Nov 19, 2010
Katia Noyes, PhD, MPH
Multiple lessons on multiple sclerosis: results of cost-effectiveness assessment of disease modifying therapies
Dec 3, 2010
Karl Kieburtz, MD, MPH
Clinical trial design in movement disorders: 20 years of change
**Whipple Auditorium (2-6424)**
Dec. 10, 2010
John Langfitt, PhD
The Promise of PROMIS (Patient-Reported Outcomes Measurement Information System)

Spring 2010 WGCT Meetings

Feb 19, 2010
Heather Adams, PhD
Clinical trial of a behavioral intervention in pediatric degenerative neurologic conditions
Mar 5, 2010
Kevin M. Biglan, MD
A randomized controlled trial of telemedicine versus in-person care for nursing home residents with Parkinson’s disease
Mar 19, 2010
Susan G. Fisher, PhD
The Rochester Family Health Partnership: the road to Shangri-La?
Apr 2, 2010
Charles Thornton, MD
Antisense oligonucleotide drugs for neurogenetic disease
Apr 23, 2010
Irene Richard, MD
A multicenter randomized, double-blind, placebo-controlled trial of antidepressants in Parkinson's disease
May 7, 2010
Ira Shoulson, MD
Predictors and precursors of disability in Parkinson Disease
May 21, 2010
Michelle Burack, MD
Continuous ambulatory accelerometry for passive monitoring of motor fluctuations in Parkinson disease
Jun 4, 2010
David Herrmann, MBBCh
Outcome measures for Charcot-Marie-Tooth neuropathy trials
Jun 18, 2010
Ronnie Guillet, MD, PhD
PROPHENO: Everything I’ve learned so far…and didn’t know I had to know!

**K-207**

 

Fall 2009 WGCT Meetings

Sept 11, 2009
Ryan Evans , MD
Remote assessments in clinical trials
Oct 2, 2009
Anton Porsteinsson, MD
CITAD: Citalopram for the treatment of agitation in dementia—challenges of designing and executing intervention studies for behavioral disturbances in dementia
Oct 16, 2009
John Markham , MD
What to Do When Unintended Consequences are Painful: Lessons from Three Recent FDA Advisory Committees
Oct 23, 2009
Michel Berg , MD
Testing the equivalence of generic and innovator AEDs: are the FDA regulations sufficient?
Oct 30, 2009
David Oakes , PhD
The randomized start design in Parkinson's disease, can it really be used to infer disease modification?
Nov 6, 2009
John Treanor , MD
Study designs for Phase 1 studies of vaccines
Nov 20, 2009
Giovanni Schifitto , MD
A pilot study of creatine for treatment of fatigue in HIV infected individuals
Dec 4, 2009
Robert Griggs, MD
The authorship lottery
Dec 18, 2009
Ray Dorsey , MD and Bernard Ravina, MD
Local IRB review of a multicenter trial: local costs without local context

Spring 2009 WGCT Meetings

Jan 23, 2009
Karl Kieburtz, MD, MPH
NET-PD multiple outcomes, global test, what does it mean?
Feb 6, 2009
Steve Lamberti, MD
Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE): overview of a landmark study
Feb 27, 2009
David Foster, MD
The 5-year experience of a dyspareunia RCT: the Vulvar Vestibulitis Clinical Trial (VVCT)
Mar 6, 2009
Mark Mapstone, PhD
The Rochester Aging Study: community-based research in cognitive aging
Mar 27, 2009
Erika Augustine, MD and the Batten Study Team
Batten Disease Clinical Trials
Apr 10, 2009
Anthony Almudevar, PhD
A pathway modeling approach to gene discovery
Apr 24, 2009
David Shprecher, DO
A clinical and biomarker discovery initiative to identify individuals with premotor Parkinson's disease
May 22, 2009
Andrew McGarry , MD
A matter of SCAle: clinical trials in SCA 6

Fall 2008 WGCT Meetings

Sep 5, 2008

Adam Kelly , MD
Expanding the role of stimulant therapy in the post-stroke period
Sep 19, 2008
Fred Marshall , MD and Peter Como, PhD
Huntington Disease Meets the FDA, Part II: Aliens vs. Predators
Oct 17, 2008
Christopher Beck, PhD
Resampling approaches to statistical inference in clinical trials
Oct 31, 2008
Steve Lamberti , MD
Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE): overview of a landmark study
Nov 21, 2008
John Langfitt , PhD
Navigating NIH Peer Review: A Case Study of an RCT of Radiosurgery vs. Lobectomy for Epilepsy
Dec 5, 2008
Charles Duffy, MD, PhD
Late-Life Cognitive Decline: Measures and Mechanisms
Dec 19, 2008
Michael McDermott, PhD
Multiple outcome variables in clinical trials: an example from a planned trial in Duchenne muscular dystrophy

Spring 2008 WGCT Meetings

Feb 8, 2008
Ray Dorsey, MD, MBA
Randomized, controlled trial of an omega-3 fatty acid for Huntington disease
Feb 22, 2008
John Markman, MD
Lumbar Stenosis Outcomes Research (LUSTOR) trials I and II: a pair of double-blind, placebo-controlled crossover trials for the treatment of neurogenic intermittent claudication
March 7, 2008
Fred Marshall, MD and Peter Como, PhD
Huntington Disease meets the FDA
Mar 28, 2008
Michael Schlossmacher, MD
Lysosomal enzymes and alpha-synuclein steady-state
Apr 11, 2008
Kevin Biglan, MD, MPH and David Oakes, PhD
Dosage selection of isradipine for the treatment of Parkinson's Disease: a two-period design
May 2, 2008
Tiffani Voss, MD
The effects of sustained physiotherapy on fall reduction in Parkinson Disease
May 23, 2008
David Shprecher, DO
A peripheral leukocyte microarray investigation of tic remission in Tourette Syndrome
Jun 20, 2008
Lahar Mehta, MD
Heparin: a different point of view and possible application in Multiple Sclerosis

Fall 2007 Working Group on Clinical Trials Meetings Schedule

Oct 12, 2007
Brandy Fureman, PhD
NINDS Clinical Trial Group
NINDS Resources for Clinical Investigations
Nov 2, 2007
TBA
Nov 16, 2007
Anthony Almudevar, PhD and Roger Kurlan, MD
Some Issues in Adaptive Methodology

Spring 2007 Working Group on Clinical Trials Meetings Schedule

Mar 2, 2007
Giovanni Schifitto, MD
Valproic Acid for HIV-Associated Cognitive Impairment: An Enhanced Phase II Study
Mar 16, 2007
Roger Kurlan, MD
Identifying the best study design for pilot efficacy trials in Tourette’s Syndrome
May 25, 2007
Steven Frucht, MD
Associate Professor of Clinical Neurology
Columbia University Medical Center
Alcohol-responsive Movement Disorders - New Treatment Options
June 15, 2007
Bernard Ravina, MD, MSCE
Timing of Treatment Initiation in PD

Fall 2006 Working Group on Clinical Trials Meetings Schedule

Sept 8, 2006
Dan Skovronsky, MD, PhD
CEO, Avid Radiopharmaceuticals
Radiopharmaceuticals for Neurodegenerative Condition
Sept 29, 2006
Alec B. O'Connor, MD
Desipramine vs. Pregabalin in Older Patients with Painful Diabetic Peripheral Neuropathy or Postherpetic Neuralgia
Nov 3, 2006
Ronnie Guillet, MD
Treatment of Infants After Resolution of Neonatal Seizures
Dec 15, 2006
Robert Dworkin, MD and Steve Schwid, MD
Proof-of-Concept Trial of Omega-3 and -6 Fatty Acid Supplementation in Multiple Sclerosis (or Clinically Isolated Syndromes?)

Spring 2006 Working Group on Clinical Trials Meetings Schedule

Jan 20, 2006
Peter Como, PhD
Quantitative Assessment of Caregiver Burden in PD
Mar 24, 2006
R. Michael Poole, MD, FACP
Practice Issues in the Implementation of Adaptive Clinical Trial Designs
Apr 28, 2006
Jeffrey L. Cummings, MD
Disease Modifying Therapies: How will we know if they are working?
May 26, 2006
John Markham, MD
Attenuation of Chronic Pain Following Lumbar Fusion:  Proposal for a Perioperative Analgesic Trial
Jun 23, 2006
Kevin Biglan, MD, MPH
Study in Presymptomatic Huntington’s Disease of Coenzyme Q10 Leading to Preventive Trials

Fall 2005 Working Group on Clinical Trials Meetings Schedule

Sept 16, 2005 Curtis Benesch, MD, MPH
Acute Stroke Treatment: Easy as APC
Oct 7, 2005
Katia Noyes, PhD, MPH
Use of administrative data for examining patterns and costs of medical care: Application for Parkinson’s disease
Nov 4, 2005
Mark Mapstone, PhD
Practical Considerations for Cognitive Endpoints in Clinical Trials
Nov 18, 2005
Anthony Lang, MD
GDNF for Parkinson’s Disease: The Theory and the Evidence
Dec 2, 2005
Donna Palumbo, PhD
Clonidine in ADHD Treatment study (CAT) primary results

Spring 2005 Working Group on Clinical Trials Meetings Schedule

Jan 21, 2005
Richard A. Lewis, MD and Michael E. Shy, MD
Dept of Neurology, Wayne State University
High Dose Vitamin C Treatment of Charcot Marie Tooth Disease Type 1A
Feb 4, 2005
Giovanni Schifitto, MD
Identifying Relevant Biomarkers of Oxidative Stress in Subjects with HIV-Associated Cognitive Impairment
Mar 11, 2005
Kimberly P. Cockerham, MD
University of California, San Francisco
Thyroid Eye Disease Pilot Study and Beyond NORDIC TED 2005
June 17, 2005
William J. Groh, MD, MPH
Cardiac Involvement in Myotonic Dystrophy Type 1
July 15, 2005
Stanley Fahn, MD
Columbia University Medical Center
Study Designs For Neuroprotective Trials in PD

Fall 2004 Working Group on Clinical Trials Meetings Schedule

Sept 10, 2004
Aileen Shinaman, JD
COHORT: Initial Steps in Planning a Longitudinal, Observational Study of Members of the HD Community
 
Sept 17, 2004
Thomas Pearson, MD, MPH, PhD
Aggressive Lipid Management: Why, What, When, and in Whom?
Oct 29, 2004
Robert Dworkin, PhD and Michael McDermott, PhD
COMBination Antineuralgic Treatment in Peripheral Neuropathic Pain
Nov 19, 2004
Rabi Tawil, MD and Michael McDermott, PhD
Investigation of Corticosteroid Regimens for Treatment of Duchenne Muscular Dystrophy
Dec 3, 2004
Jonathan W. Mink, MD, PhD
Quantitative Assessment of Chorea and Dystonia
Dec 10, 2004
Kathy Hoeger, MD
Clinical Trials in the Long-term Management of Polycystic Ovary Syndrome (PCOS)

Spring 2004 Working Group on Clinical Trials Meetings Schedule

January 9 Anthony Arnold, MD Epidemiology of Ischemic Optic Neuropathy
Januray 23 Giovanni Schifitto, MD DideoxyNucleosides: Do they contribute to HIV-associated distal sensory polyneuropathy?
February 13 Jill Halterman, MD Benefits of a school-based asthma treatment program in the absence of second-hand smoke exposure: results of a randomized clinical trial
February 27 David S. Knopman, MD Design controversies in mild cognitive impairment trials
March 19 Merit E. Cudkowicz, MD DOMINO-HD: A multi-site, double-blind pilot study of minocycline in subjects with Huntington's disease
March 26 David Oakes, PhD A Phase III Study of Coenzyme Q10 in Early Parkinson's Disease
April 16 Gene E. Watson II, DDS, PhD Establishing a General Dental Practice-Based Research Network
May 7 Pierre Tariot, MD Designing an Effectiveness Trial for Treatment of Alzheimer's Disease: Now is the Time!
May 21 TBD TBD
June 11 TBD TBD