All CTMC webinars are open to anyone who is interested (not just the enrolled course participants). All webinars are recorded and posted below for later review. Please click
h ere to evaluate each webinar.
2020 WEBINAR SERIES
Objectives of the webinar series
Participants will improve their knowledge of the design and conduct of clinical trials in the neurosciences;
Analyze the information presented; and
Integrate relevant content into the design and conduct of clinical trials.
Core competencies
Medical Knowledge
Professionalism
Systems-Based Practice
Unless otherwise stated generally webinars are held at 12PM EST ( https://umich-health.zoom.us/j/91093892852 ) – please use a computer with webcam, or the Zoom app if possible. DO NOT CALL AND USE COMPUTER AUDIO SIMULTANEOUSLY.
Prior to each webinar: Each webinar (May - October) has a link to an archived presentation that you will review on Youtube BEFORE the webinar date. During the live webinar there will be a brief overview of the archived presentation followed by a Q&A session of the presented topic. Please come to the webinar with questions and ready to share your thoughts. Please note the topics listed below are subject to change based on feedback and presenter availability.
Evaluation: Please EVALUATE each webinar here .
January 7: CTMC Informational Webinar - Presented by Course Directors
May 5: Asking a Good Early Phase Clinical Question in the Era of a Pandemic - Presented by Will Meurer, MD (review https://youtu.be/HJkbj2_1WfU )
May 19: Pilot and Feasibility Trials - Presented by Lehana Thabane, PhD (review https://youtu.be/bljPT9whkQo )
June 2: Outcome Measures - Presented by Harold Adams, MD (review https://youtu.be/4uwkEJTjhFQ )
June 16: NINDS Health Disparities & Global Health Agenda / Common Data Elements - Presented by Robin Conwit, MD, Carolina Mendoza-Puccini, MD & Richard Benson, MD, PhD (review https://youtu.be/echQNjxQ_Hk )
July 7: Rigor and Transparency - Presented by Laurie Gutmann, MD and Dietrich Haubenberger, MD (review https://youtu.be/bZTSS07BL0E )
July 21: What to Know About Sample Size - Presented by Sharon Yeatts, PhD (review https://youtu.be/PZcm57CTKsk )
August 4: Rare Disease Trials - Presented by Chris Coffey, PhD and Melanie Quintana, PhD (review https://youtu.be/36hM3p706W4 )
August 25: Specific Aims - Presented by Jordan Elm, PhD and Robert Silbergleit, MD (review https://youtu.be/j4-2eRwy450 )
September 1: Adverse Event and Safety Reporting - Presented by Dixie Ecklund RN, MSN, MBA, CCRC and Bob Fox, MD (review https://youtu.be/Wl83_jdE71M )
September 15: Ethical Issues in Acute and Chronic Neurological Conditions - Presented by Michael Linke, PhD (review https://youtu.be/KRqhWM_O_3o )
October 6: Age as a Biological Variable - Trials with Children, Adults or Both - Presented by Adam Hartman, MD (review https://youtu.be/W136OLu2oZA )
October 27: Trial Management - Presented by Marianne Kearney Chase (review https://youtu.be/YZP6YXb1cn8 )
November 3: From Statistical Significance to Clinical Significance: Time to Dethrone or get rid of Significance? - Presented by Lehana Thabane, PhD
November 17: What will the CTMC look like in 2021? - Presented by Course Directors
Most Recent Webinars:
What will the CTMC look like in 2021?
November 17, 2020
Presented by Course Directors
Slides
From Statistical Significance to Clinical Significance: Time to Dethrone or get rid of Significance?
November 3, 2020
Presented by Lehana Thabane, PhD
Slides
__________________________________________________________________________________________________________________________________________________
Click on the links below to view the webinars in each category.
What You Need to Know Before Talking to Your Statistician About Sample Size
What to Know About Sample Size
July 21, 2020
Presented by Dr. Sharon Yeatts
Please EVALUATE the webinar here .
May 14, 2019
Sample Size
Presented by Sharon Yeatts, PhD
Slides
July 16, 2018
Sample Sizes
Presented by Sharon Yeatts, PhD
Slides
June 9, 2017
Presented by: Sharon Yeatts, PhD
Slides
Rigor and Transparency: How to Use Preclinical Data to Inform Trials
Rigor and Transparency
July 7, 2020
Presented by Drs. Laurie Gutmann, Dietrich Haubenberger and Will Meurer
Slides
Please EVALUATE the webinar here .
May 12, 2017
Presented by: Laurie Gutmann, MD, and Will Meurer, MD, MS
Slides
Specific Aims
Specific Aims
August 25, 2020
Presented by Drs. Jordan Elm and Robert Silbergleit
June 13, 2018
Presented by Robert Silbergleit, MD
Crafting a Specific Aims Page for an Early Clinical Trial
May 6, 2016
Presented by Robert Silbergleit, MD
September 11, 2015
Presented by Robert Silbergleit, MD
VIDEO
Small Sample Size Clinical Trials
May 28, 2019
Presented by Chris Coffey, PhD
Slides
May 26, 2017
Presented by Chris Coffey, PhD
Asking a good early phase clinical trial question
May 5, 2020
Asking a Good Early Phase Clinical Question in the Era of a Pandemic
Presented by Will Meurer, MD
Evaluation: Please EVALUATE the webinar here .
April 16, 2019
Asking A Good Early Phase Clinical Question
Presented by Will Meurer, MD
Slides
June 25, 2018
Office Hours (Review "Asking a Good Early Phase Clinical Trial Question ")
Presented by Course Directors
April 28, 2017
Presented by: Roger Lewis, MD, PhD
Slides and referenced article on Equipoise
April 15, 2016
Presented by Roger Lewis, MD
CTMC Introduction:
Introduction to the CTMC
January 14, 2019
Presented by Will Meurer, MD
Slides
CTMC 2016 Informational Webinar
January 19, 2016
Presented by Will Meurer, MD
VIDEO
Introduction to CTMC
April 10, 2015
Presented by Will Meurer, MD, MS
VIDEO
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Top
Adaptive Design Clinical Trials:
A Regulatory Perspective on Adaptive Designs
Attachments: scott_NINDS_CTM_webinar_062415.pdf
June 24, 2015 Presented by John Scott, PhD
VIDEO
An Introduction to Adaptive Clinical Trial Design
May 13, 2015
Presented by Roger J. Lewis, MD, PhD, FACEP
VIDEO
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Top
Adverse Events & Safety Monitoring:
Adverse Event and Safety Reporting
September 1, 2020
Presented by Dixie Ecklund and Robert Fox
Data and Safety, IMM, AE Reporting
July 2, 2019
Presented by Roger Lewis, MD
Slides
Adverse Event and Safety Monitoring in Clinical Trials
October 7, 2016 Presented by Robert Silbergleit, MD
Biomarkers:
Biomarkers
June 11, 2019
Presented by James Berry, MD
Slides
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Budgeting:
Creating a Budget for a Single-Site Clinical Trial
Slides
July 15, 2016 Presented by Valerie Stevenson, BAS, RRT, CCRP, the Administrative Director of the Neurological Emergencies Treatment Trials (NETT) Clinical Coordinating Center, in the Department of Emergency Medicine at the University
Clinical Trial Budgeting
Slides
October 11, 2014 Presented by Valerie Stevenson, BAS, RRT, CCRP, the Administrative Director of the Neurological Emergencies Treatment Trials (NETT) Clinical Coordinating Center, in the Department of Emergency Medicine at the University of Michigan.
VIDEO
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Clinical Trials:
Speaking Clinical Trials
Slides
July 18, 2014 Presented by Marianne Kearney, (Director of Research Operations, Neurological Clinical Research Institute (NCRI), Massachusetts General Hospital)
VIDEO
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Top
Common Data Elements
NINDS Health Disparities & Global Health Agenda / Common Data Elements
June 16, 2020
Presented by Drs. Richard Benson, Carolina Mendoza-Puccini and Robin Conwit
Slides
November 5, 2018
Common Data Elements
Presented by Robin Conwit, MD, Carolina Mendoza-Puccini, MD, and Alex Sherman
Slides
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Top
Common Rule Changes
November 17, 2017
Changes to the Common Rule
Presented by Judy Birk, JD
Slides
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Data Management:
Data Management
July 30, 2018
Presented by: Catherine Dillon, BS, CCRP
Slides
July 21, 2017
Presented by: Catherine Dillon, BS, CCRP
Slides
Ethical Issues for Clinical Trials in Neuroscience
Slides
July 11, 2014 Presented by Dixie Ecklund, RN, MSN, MBA (Associate Director, Clinical Trials Statistical & Data Management Center, University of Iowa)
VIDEO
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Top
Good Clinical Practice
Good Clinical Practices
Slides
October 1, 2019
Presented by Dixie Ecklund, RN, MSN, MBA and Marianne Kearney-Chase
EVALUATE THE WEBINARS
Good Clinical Practice
Slides
September 10, 2018
Presented by Dixie Ecklund and Marianne Kearney-Chase
EVALUATE THE WEBINARS
Good Clinical Practice
Slides
September 8, 2017
Presented by Marianne Kearney Chase and Dixie Ecklund, RN, MSN, MBA
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Top
Human Subjects Protection:
Special topics in human subjects protection: acute and chronic conditions in neurology
Slides
October 12, 2016
Presented by: Pearl O'Rourke, MD
Evaluation: Please EVALUATE the webinar here .
Outcomes
April 30, 2019
Presented by Harold Adams, MD and Jeremy Shefner
Slides -Adams Slides -Shefner
Where Do Clinical Outcome Measures Come From?
June 18, 2018
Presented by Harold Adams, MD
Slides
VIDEO
]
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Top
Partnerships:
Partnering with Industry
June 25, 2019
Presented by Jeffrey Saver, MD
Slides
Approaching Industry and Patient Groups for Partnerships
May 8, 2015
Presented by Michael E. Shy, MD
VIDEO
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Patient Population:
Selecting the right population
Slides
June 27,2014
Presented by Drs. Meurer and Gutmann
VIDEO
Pilot and Feasibility Trials in the Era of a Pandemic
May 19, 2020
Presented by Lehana Thabane, PhD
Evaluation: Please EVALUATE the webinar here .
July 24, 2018
Tutorial on Pilot Studies
Presented by Lehana Thabane, PhD
Slides
October 29, 2018
Pragmatic Trials
Presented by Shaun Treweek, PhD
Slides
Rare Disease Trials:
Rare Disease Trials
August 4, 2020
Presented by Drs. Chris Coffey and Melanie Quintana
Rare Disease Trials
July 16, 2019
Presented by Melanie Quintana, PhD
Slides
Reflections on the CTMC N Years Later:
Ocober 11, 2018
Reflections on the CTMC N Years Later
Presented by Sarah Pirio Richardson, MD, Andrew Southerland, MD and Hooman Kamel, MD
September 23, 2016
Screening and enrollment: How to Ensure You Have Subjects
Presented by: Dixie Ecklund and Marianne Kearney
Slides
September 5, 2018
Sex as a Biological Variable in Grant Review
Presented by: Cheryl Bushnell, MD
Slides
Significance (Statistical and Clinical):
From Statistical Significance to Clinical Significance: Time to Dethrone or get rid of Significance?
November 3, 2020
Presented by Lehana Thabane, PhD
Slides
Top
Understanding Simulations: Why to do them, How to use them, What to learn
May 27, 2015
Presented by Scott Berry, PhD
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Top
Study Design:
Study Design for Early Phase Clinical Trials
Slides
June 26, 2015
Presented by Chris Coffey, PhD
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Top
Study Drug Formulation and Supply Issues
August 13, 2018
Presented by Pat Bolger, RPh, MBA
Slides
July 14, 2017
Presented by: Pat Bolger, R.Ph., MBA
Slides
Study Sections
Study Sections in Clinical Trials
September 24, 2019
Presented by Jaideep Kapur, MD and David Wright, MD
Slides
Clinical Trials Study Sections
September 24, 2018
Presented by Jaideep Kapur, MBBS, PhD and David Wright, MD, FACEP
Slides
Clinical Trials Study Sections
October 13, 2017
Presented by Jaideep Kapur, MBBS, PhD and David Wright, MD, FACEP
Slides
Clinical Trial Study Sections
Slides
September 9, 2016 Presented by Jill Baren, MD, MBE, FACEP, FAAP, Jaideep Kapur, MBBS, PhD, and David Wright, MD, FACEP
Trial Management
Trial Management
October 27, 2020
Presented by Marianne Kearney-Chase
September 17, 2018
Presented by: Will Meurer, Md
Office Hours - Trial Management
September 15, 2017
Presented by: Mary Farrant, MBA, RN
Slides
Writing a Good Proposal
Writing a good proposal
September 16, 2015
Presented by Karen Johnston, MD, MSc; Will Meurer, MD, MS; and David Wright, MD, FACEP
VIDEO
Writing a good Proposal
November 20, 2014
Presented by Karen Johnston, MD, MSc; Will Meurer, MD, MS; Robert Silbergleit, MD; and David Wright, MD, FACEP
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Writing a Protocol:
Writing a Great Protocol: Opportunities and Pitfalls
Slides
June 12, 2015
Presented by Dixie Ecklund, RN, MSN, MBA, CCRC and Marianne Kearney Chase, BA
What information you need to start writing your protocol
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