URMC / Department of Biostatistics and Computational Biology / News & Events / Working Group on Clinical Research

Working Group on Clinical Research

The Working Group on Clinical Research (formerly Working Group on Clinical Trials) 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.

Fall 2015 WGCR Meetings

Sep 18, 2015	Thomas Wychowski, MD Optimizing AED trials in Tumor-related Epilepsy	7:45 - 8:45 am Garvey Conference Room: 5.5220
Sep 25, 2015	Jonathan Mink, MD, PhD Incorporation of a Research Track into Residency Training	7:45 - 8:45 am Garvey Conference Room: 5.5220
Oct 23, 2015	Jennifer Kwon, MD, MPH Pompe Disease Newborn Screening: Incorporating Quality Improvement into Clinical Follow-up	7:45 - 8:45 am Garvey Conference Room: 5.5220
Nov 13, 2015	Kimberly Van Orden, PhD Volunteering as Late-Life Suicide Prevention: R01 Proposal	7:45 - 8:45 am Garvey Conference Room: 5.5220
Dec 11, 2015	Charles Thornton, MD Phase 1/2a Trial of Isis 598769 in Myotonic Dystrophy	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.

Spring 2015 WGCR Meetings

Jul 31, 2015	John Langfitt, PhD Assessment of Disruptive Behavior in Sub-Saharan African Children	7:45 - 8:45 am Garvey Conference Room: 5.5220
Jun 12, 2015	Jonathan Mink, MD, PhD Embouchure Dystonia in Brass Musicians	7:45 - 8:45 am Garvey Conference Room: 5.5220
May 22, 2015	Spyros Papapetropoulos, MD, PhD Rewiring Drug Development in Neurodegenerative Diseases	7:45 - 8:45 am Physical Medicine & Rehab Room: 5.4121
May 8, 2015	Christine Annis Robert Holloway, MD, PhD UR NEXT Update	7:45 - 8:45 am Physical Medicine & Rehab Room: 5.4121
Apr 10, 2015	Robert Dworkin, PhD FDA Qualification of Clinical Outcome Assessments: How Arduous Will It Be to Develop QUALITE-Pain	7:45 - 8:45 am Garvey Conference Room: 5.5220
Apr 3, 2015	Ruth Schneider, MD Irene Richard, MD The Safety and Tolerability of Buspirone for the Treatment of Anxiety in Parkinson Disease	7:45 - 8:45 am Garvey Conference Room: 5.5220
Mar 27, 2015	Miriam Weber, PhD Mechanisms of Memory Dysfunction in the Menopausal Transition	7:45 - 8:45 am Garvey Conference Room: 5.5220
Mar 20, 2015	Bogachan Sahim, MD, PhD A Role for SSRI’s in Post-Stroke Visual Recovery	7:45 - 8:45 am Garvey Conference Room: 5.5220
Feb 27, 2015	John Markman, MD Jennifer Gewandter, PhD, MPH Simplified Pain Evaluation and Communication Tool Utilizing the Electronic Record (SPECTER): A Cluster Randomized Trial	7:45 - 8:45 am Keck Conference Room 5.5725
Jan 9, 2015	Charles Venuto, PharmD Parkinson’s Disease Progression: Learning from the Past to Predict the Future	7:45 - 8:45 am Garvey Conference Room: 5.5220

Fall 2014 WGCT Meetings

Sep 12, 2014	Benjamin T. Crane, MD, PhD, FACS A New Method for Vestibular Rehabilitation	7:45 - 8:45 am PM&R Conference Room: 5.4121
Sep 26, 2014	Giovanni Schifitto, MD, MS Vascular Aging and HIV Infection	7:45 - 8:45 am Garvey Conference Room: 5.5220
Oct 03, 2014	Gretchen L. Birbeck, MD, MPH Aggressive Antipyretics for Fever Control in Pediatric CNS Malaria	7:45 - 8:45 am Garvey Conference Room: 5.5220
Oct 10, 2014	E. Ray Dorsey, MD, MBA A National Randomized, Controlled Trial of Telemedicine for Parkinson Disease	7:45 - 8:45 am Garvey Conference Room: 5.5220
Oct 17, 2014	Barney J. Stern, MD Let the GAMES (Glyburide Advantage in Malignant Edema and Stroke) Begin!	7:45 - 8:45 am Garvey Conference Room: 5.5220
Nov 14, 2014	Megan Hyland, MD, MS Jessica Robb, MD Telemedicine in Multiple Sclerosis	7:45 - 8:45 am PM&R Conference Room: 5-4121
Dec 12, 2014	Kevin Biglan, MD, MPH Kelly Andrzejewski, DO, PhD REACT-PD: A Study of Virtual Research Visits in a Phase III Clinical Trial	7:45 - 8:45 am Garvey Conference Room: 5.5220
Dec 19, 2014	Tetsuo Ashizawa, MD Translational Approaches in Myotonic Dystrophy	7:45 - 8:45 am Garvey Conference Room: 5.5220

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

Fall 2013 WGCT Meetings

Nov 1, 2013

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

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 UR 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
January 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!