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 2012 WGCT Meetings
TIME: 7:45 - 8:45 am
PLACE: Garvey Room (Med Center 5-5220) unless otherwise noted*
| Jan 13, 2012 |
- Jim White, MD, PhD
- Goldilox and 3 Doses of Treprostinil
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| Jan 20, 2012 |
- Annie Killoran, MD
- Feasibility of Phase III Clinical Trials in Pre-Manifest Huntington’s Disease
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| Jan 27, 2012 |
- Nancy Bennett, MD
- Comparative Effectiveness of Practice-Based Diabetes Prevention Programs
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* Please contact Lisa Oppelt at 275-0800 for room confirmation or with questions concerning the above schedule.
Fall 2011 WGCT Meetings
| Oct 21, 2011 |
- Yeates Conwell, MD
- The Senior Connection: An RCT of peer support to reduce risk for suicide
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| Nov 11, 2011 |
- David Herrmann, MB BCh
- Proposal for a Treatment Trial for Muscle Cramps in Charcot Marie Tooth Disease
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| Nov 18, 2011 |
- Amy-Lee Bredlau, MD, FAAP
- A phase II study of Ketamine in children
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| Dec 9, 2011 |
- Charles Venuto, PharmD
- Quantifying Huntington's Disease Progression: A Pharmacometrics Approach
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Spring 2011 WGCT Meetings
| Feb 18, 2011 |
- Rabi Tawil, MD
- Optimizing Clinical Outcome Measures in FSH Muscular Dystrophy
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| 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
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| Jun 17, 2011 |
- Anthony Pietropaoli , MD
- Sodium nitrite therapy in severe sepsis: a novel intervention targeting microvascular blood flow
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Fall 2010 WGCT Meetings
| Sept 17, 2010 |
- James Cloyd, PharmD
- Challenges in developing intravenous topiramate for neonatal seizures
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| Sept 24, 2010 |
- Robert Holloway, MD, MPH
- Conflicts of interest: the perils and promise of transparency
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| Oct 22, 2010 |
- Robert Gross, MD, PhD
- Publishing trials: the editorial perspective
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| 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
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Clinical trial design in movement disorders: 20 years of change
- **Whipple Auditorium (2-6424)**
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| Dec. 10, 2010 |
- John Langfitt, PhD
- The Promise of PROMIS (Patient-Reported Outcomes Measurement Information System)
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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
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| Apr 23, 2010 |
- Irene Richard, MD
- A multicenter randomized, double-blind, placebo-controlled trial of antidepressants in Parkinson's disease
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| 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
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| Jun 18, 2010 |
- Ronnie Guillet, MD, PhD
- PROPHENO: Everything I’ve learned so far…and didn’t know I had to know!
**K-207**
-
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Fall 2009 WGCT Meetings
| Sept 11, 2009 |
- Ryan Evans , MD
- Remote assessments in clinical trials
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| 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
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| Oct 16, 2009 |
- John Markham , MD
- What to Do When Unintended Consequences are Painful: Lessons from Three Recent FDA Advisory Committees
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| 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
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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
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| Dec 19, 2008 |
- Michael McDermott, PhD
- Multiple outcome variables in clinical trials: an example from a planned trial in Duchenne muscular dystrophy
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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
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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
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| 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?)
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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
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| 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
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| Jun 23, 2006 |
- Kevin Biglan, MD, MPH
- Study in Presymptomatic Huntington’s Disease of Coenzyme Q10 Leading to Preventive Trials
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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
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| Dec 2, 2005 |
- Donna Palumbo, PhD
- Clonidine in ADHD Treatment study (CAT) primary results
|
* Please contact Debbie Baker at 275-0553 for room confirmation or with questions concerning the above schedule.
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
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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
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| 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 |