Department of Biostatistics and Computational Biology at University of Rochester

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.

Fall 2008 WGCT Meetings

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

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 TBA
Dec 19, 2008	Michael McDermott, PhD Multiple outcome variables in clinical trials: an example from a planned trial in Duchenne muscular dystrophy

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

Spring 2008 WGCT Meetings

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

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

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

Fall 2007 Working Group on Clinical Trials Meetings Schedule

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

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

* Please contact Debbie Baker at 275-0553 for room confirmation or with questions concerning the above schedule.

Spring 2007 Working Group on Clinical Trials Meetings Schedule

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

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

* Please contact Debbie Baker at 275-0553 for room confirmation or with questions concerning the above schedule.

Fall 2006 Working Group on Clinical Trials Meetings Schedule

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

Sept 8, 2006	Dan Skovronsky, MD, PhD CEO, Avid Radiopharmaceuticals Radiopharmaceuticals for Neurodegenerative Conditions * * * Mt. Hope Professional Bldg, Windows Conference Room (next to Ste. 202) * * *
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?)

* Please contact Debbie Baker at 275-0553 for room confirmation or with questions concerning the above schedule.

Spring 2006 Working Group on Clinical Trials Meetings Schedule

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

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

* Please contact Debbie Baker at 275-0553 for room confirmation or with questions concerning the above schedule.

Fall 2005 Working Group on Clinical Trials Meetings Schedule

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

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

* 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

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

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 Mt. Hope Professional Bldg., Ste. 206
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

* Please contact Debbie Baker at 275-0553 for room confirmation or with questions concerning the above schedule.

Fall 2004 Working Group on Clinical Trials Meetings Schedule

TIME: 7:45 - 8:45 AM
PLACE: GARVEY ROOM (Med Center 5-5220) unless otherwise noted*

Sept 10, 2004	Aileen Shinaman, JD COHORT: Initial Steps in Planning a Longitudinal, Observational Study of Members of the HD Community Biostats Conference Room MRBX G-11213
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)

* Please contact Beverly Olsen at 273-4038 for room confirmation or with questions concerning the above schedule.

Spring 2004 Working Group on Clinical Trials Meetings Schedule

TIME: 7:45 - 8:45 AM
PLACE: GARVEY ROOM (Medical Center 5-5220)*

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

* Please contact Beverly Olsen at 273-4038 for room confirmation or with questions concerning the above schedule.

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