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Living Textbook of
Pragmatic Clinical Trials

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Access the latest information on COVID-19 for clinical researchers
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Rethinking Clinical Trials

A Living Textbook of Pragmatic Clinical Trials

  • Design
    • What is a Pragmatic Clinical Trial?
    • Decentralized Pragmatic Clinical Trials
    • Developing a Compelling Grant Application
    • Experimental Designs and Randomization Schemes
    • Endpoints and Outcomes
    • Analysis Plan
    • Using Electronic Health Record Data
    • Building Partnerships and Teams to Ensure a Successful Trial
    • Intervention Delivery and Complexity
    • Patient Engagement
  • Data, Tools & Conduct
    • Assessing Feasibility
    • Acquiring Real-World Data
    • Assessing Fitness-for-Use of Real-World Data
    • Study Startup
    • Participant Recruitment
    • Monitoring Intervention Fidelity and Adaptations
    • Patient-Reported Outcomes
    • Clinical Decision Support
    • Mobile Health
    • Electronic Health Records–Based Phenotyping
    • Navigating the Unknown
  • Dissemination & Implementation
    • Data Sharing and Embedded Research
    • Dissemination Approaches for Different Audiences
    • Implementation
    • End-of-Trial Decision-Making
  • Ethics & Regulatory
    • Privacy Considerations
    • Identifying Those Engaged in Research
    • Collateral Findings
    • Consent, Disclosure, and Non-Disclosure
    • Data and Safety Monitoring
    • Ethical Considerations of Data Sharing in Pragmatic Clinical Trials
    • Ethics for AI and ML
    • IRB Responsibilities and Procedures
67 events found.

Events

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  • July 2017

  • Fri 28

    Grand Rounds: July 28: The DSMB Role in Pragmatic Trials: NIMH Progress and Challenges (Galia Siegel, PhD; Anna Ordonez, MD, MAS; Scott Kim, MD, PhD; Kate Comtois, PhD, MPH)

    July 28, 2017 @ 1:00 pm - 2:00 pm
    https://dukemed.webex.com/dukemed/j.php?MTID=m4c6e3e4827442a92338a5649cee613e6

    ​Speakers: Galia Siegel, PhD Clinical Trials Program Coordinator Clinical Trials Operations and Biostatistics Branch Office of Clinical Research National Institute of Mental Health, NIH Anna E. Ordóñez, MD, MAS Deputy […]

  • Fri 28

    Grand Rounds: July 28: The DSMB Role in Pragmatic Trials: NIMH Progress and Challenges (Galia Siegel, PhD; Anna Ordonez, MD, MAS; Scott Kim, MD, PhD; Kate Comtois, PhD, MPH)

    Featured July 28, 2017 @ 1:00 pm - 2:00 pm
    https://dukemed.webex.com/dukemed/j.php?MTID=m4c6e3e4827442a92338a5649cee613e6

    ​Speakers: Galia Siegel, PhD Clinical Trials Program Coordinator Clinical Trials Operations and Biostatistics Branch Office of Clinical Research National Institute of Mental Health, NIH Anna E. Ordóñez, MD, MAS Deputy […]

  • August 2017

  • Fri 11

    Grand Rounds: August 11: Embedding Clinical Trials Into Care Delivery: The Vanderbilt Experience (Gordon Bernard, MD)

    August 11, 2017 @ 1:00 pm - 2:00 pm
    https://dukemed.webex.com/dukemed/j.php?MTID=m4c6e3e4827442a92338a5649cee613e6

    ​Speaker: Gordon R. Bernard, MD Melinda Owen Bass Professor of Medicine Executive Vice President for Research Director, Vanderbilt Institute for Clinical and Translational Research Vanderbilt University Medical Center Topic: Embedding Clinical […]

  • Fri 11

    Grand Rounds: August 11: Embedding Clinical Trials Into Care Delivery: The Vanderbilt Experience (Gordon Bernard, MD)

    Featured August 11, 2017 @ 1:00 pm - 2:00 pm
    https://dukemed.webex.com/dukemed/j.php?MTID=m4c6e3e4827442a92338a5649cee613e6

    ​Speaker: Gordon R. Bernard, MD Melinda Owen Bass Professor of Medicine Executive Vice President for Research Director, Vanderbilt Institute for Clinical and Translational Research Vanderbilt University Medical Center Topic: Embedding Clinical […]

  • Fri 18

    Grand Rounds: August 18: Behavioral Economic Incentives in Adolescents and Young Adults: A Developmental Framework and RCT of Financial Incentives in Youth with Type 1 Diabetes (Charlene Wong, MD)

    August 18, 2017 @ 1:00 pm - 2:00 pm
    https://dukemed.webex.com/dukemed/j.php?MTID=m4c6e3e4827442a92338a5649cee613e6

    ​Speaker: Charlene Wong, MD Assistant Professor Department of Pediatrics Duke Clinical Research Institute Margolis Center for Health Policy Duke University Topic: Behavioral Economic Incentives in Adolescents and Young Adults: A Developmental […]

  • Fri 18

    Grand Rounds: August 18: Behavioral Economic Incentives in Adolescents and Young Adults: A Developmental Framework and RCT of Financial Incentives in Youth with Type 1 Diabetes (Charlene Wong, MD)

    Featured August 18, 2017 @ 1:00 pm - 2:00 pm
    https://dukemed.webex.com/dukemed/j.php?MTID=m4c6e3e4827442a92338a5649cee613e6

    ​Speaker: Charlene Wong, MD Assistant Professor Department of Pediatrics Duke Clinical Research Institute Margolis Center for Health Policy Duke University Topic: Behavioral Economic Incentives in Adolescents and Young Adults: A Developmental […]

  • Fri 25

    Grand Rounds August 25: Update and Thoughts from the Phenotypes, Data Standards, and Data Quality Core of the NIH HCS Research Collaboratory (Rachel Richesson, PhD, MPH)

    Featured August 25, 2017 @ 1:00 pm - 2:00 pm
    https://dukemed.webex.com/dukemed/j.php?MTID=m4c6e3e4827442a92338a5649cee613e6

    Speaker: Rachel Richesson, PhD, MPH Associate Professor Duke University School of Nursing Topic: Update and Thoughts from the Phenotypes, Data Standards, and Data Quality Core of the NIH HCS Research […]

  • September 2017

  • Fri 8

    Grand Rounds September 8: Leveraging Informatics in Pragmatic Research: Initial Experience in PCORnet (Russell Rothman, MD, MPP)

    Featured September 8, 2017 @ 1:00 pm - 2:00 pm
    https://dukemed.webex.com/dukemed/j.php?MTID=m4c6e3e4827442a92338a5649cee613e6

    Speaker: Russell Rothman, MD, MPP Professor, Internal Medicine, Pediatrics, & Health Policy Vice President for Population Health Research Director, Center for Health Services Research Vanderbilt University Medical Center Topic: Leveraging […]

  • Fri 15

    Grand Rounds September 15, 2017: Who to Include in a Pragmatic Trial? It Depends (Greg Simon, MD; Laura Dember, MD)

    Featured September 15, 2017 @ 1:00 pm - 2:00 pm
    https://dukemed.webex.com/dukemed/j.php?MTID=m4c6e3e4827442a92338a5649cee613e6

    Speakers: Greg Simon, MD, MPH Senior Investigator Kaiser Permanente Washington Health Research Institute Laura Dember, MD Professor of Medicine University of Pennsylvania Perelman School of Medicine Topic: Who to Include in a Pragmatic Trial? It Depends Date: Friday, September 15, 2017, 1:00-2:00 p.m. ET Meeting Info: To check whether you have the appropriate players installed […]

  • Fri 22

    Grand Rounds September 22: Improving Evidence Generation for Medical Devices: The New National Evaluation System for Health Technology (NEST) (Rachael Fleurence, PhD)

    Featured September 22, 2017 @ 1:00 pm - 2:00 pm
    https://dukemed.webex.com/dukemed/j.php?MTID=m4c6e3e4827442a92338a5649cee613e6

    Speaker: Rachael Fleurence, PhD Executive Director NEST Coordinating Center Medical Device Innovation Consortium (MDIC) Topic: Improving Evidence Generation for Medical Devices: The New National Evaluation System for Health Technology (NEST) Date: Friday, September 22, 2017, 1:00-2:00 p.m. ET Meeting Info: To check whether you have the appropriate players installed for UCF (Universal Communications Format) rich […]

  • Fri 29

    Grand Rounds September 29: Preprints: What, Why Not and How (Harlan M. Krumholz, MD)

    Featured September 29, 2017 @ 1:00 pm - 2:00 pm
    https://dukemed.webex.com/dukemed/j.php?MTID=m4c6e3e4827442a92338a5649cee613e6

    Speakers: Harlan M. Krumholz, MD Harold H. Hines, Jr. Professor of Medicine Yale University School of Medicine Director, Center for Outcomes Research and Evaluation Yale-New Haven Health System Founder, Hugo Topic: Preprints: What, Why Not and How Date: Friday, September 29, 2017, 1:00-2:00 p.m. ET Meeting Info: To check whether you have the appropriate players […]

  • October 2017

  • Fri 6

    Grand Rounds October 6: Health Is More Than Healthcare (Karen B. DeSalvo, MD, MPH, MSc)

    Featured October 6, 2017 @ 1:00 pm - 2:00 pm
    https://dukemed.webex.com/dukemed/j.php?MTID=m4c6e3e4827442a92338a5649cee613e6

    Speaker: Karen DeSalvo, MD, MPH, MSc Former US HSS Acting Assistant Secretary for Health, National Coordinator for Health Information Technology Topic: Health Is More Than Healthcare Date: Friday, October 6, 2017, 1:00-2:00 p.m. ET Meeting Info: To check whether you have the appropriate players installed for UCF (Universal Communications Format) rich media files, go to […]

  • Fri 6

    Grand Rounds October 6: Health is More than Healthcare (Karen DeSalvo, PhD)

    October 6, 2017 @ 1:00 pm - 2:00 pm

    Speakers: Karen DeSalvo, PhD Topic: Health is More than Healthcare Date: Friday, October 6, 2017, 1:00-2:00 p.m. ET Meeting Info: To check whether you have the appropriate players installed for […]

  • Fri 13

    Grand Rounds October 13: Users’ Guide for Integrating Patient-Reported Outcomes in Electronic Health Records (Claire Snyder, PhD; Albert Wu, MD, MPH)

    Featured October 13, 2017 @ 1:00 pm - 2:00 pm
    https://dukemed.webex.com/dukemed/j.php?MTID=m4c6e3e4827442a92338a5649cee613e6

    Speakers: Claire Snyder, PhD Professor of Medicine, Oncology, and Health Policy & Management Johns Hopkins Schools of Medicine and Public Health Albert W. Wu, MD, MPH, FACP Professor and Director Center for Health Services & Outcomes Research Johns Hopkins Bloomberg School of Public Health Topic: Users’ Guide for Integrating Patient-Reported Outcomes in Electronic Health Records […]

  • Fri 20

    Grand Rounds October 20: Automated Public Health Surveillance Using Electronic Health Record Data (Michael Klompas MD, MPH, FIDSA, FSHEA)

    Featured October 20, 2017 @ 1:00 pm - 2:00 pm
    https://dukemed.webex.com/dukemed/j.php?MTID=m4c6e3e4827442a92338a5649cee613e6

    Speaker: Michael Klompas, MD, MPH, FIDSA, FSHEA Associate Professor Department of Population Medicine Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, MA Topic: Automated Public Health Surveillance Using Electronic Health Record Data Date: Friday, October 20, 2017, 1:00-2:00 p.m. ET Meeting Info: To check whether you have the appropriate players installed for UCF (Universal […]

  • November 2017

  • Fri 10

    Grand Rounds November 10: No Presentation (Veterans Day Holiday Weekend)

    November 10, 2017
    https://dukemed.webex.com/dukemed/j.php?MTID=m4c6e3e4827442a92338a5649cee613e6

    There will be no Grand Rounds presentation November 10, 2017 in observance of Veterans Day.  We hope to see you next week for "ICD-Pieces:  From Planning to Performance" by Miguel A. Vazquez, MD, and George Oliver, MD, .

  • Fri 17

    Grand Rounds November 17: ICD-Pieces: From Planning to Performance (Miguel A. Vazquez, MD; George Oliver, MD)

    Featured November 17, 2017 @ 1:00 pm - 2:00 pm
    https://dukemed.webex.com/dukemed/j.php?MTID=m4c6e3e4827442a92338a5649cee613e6

    Speakers: Miguel A. Vazquez, MD Professor of Medicine Clinical Chief Nephrology Division UT Southwestern Medical Center George Oliver, MD Vice President Clinical Informatics Parkland Center for Clinical Innovation Topic: ICD-Pieces:  From Planning to Performance Date: Friday, November 17, 2017, 1:00-2:00 p.m. ET Meeting Info: To check whether you have the appropriate players installed for UCF […]

  • Fri 24

    Grand Rounds November 24: No Presentation (Thanksgiving Holiday Weekend)

    November 24, 2017 @ 1:00 pm - 2:00 pm
    https://dukemed.webex.com/dukemed/j.php?MTID=m4c6e3e4827442a92338a5649cee613e6

    There will be no Grand Rounds presentation November 24, 2017 in observance of Thanksgiving Day.  We hope to see you next week. .  

  • December 2017

  • Fri 1

    Grand Rounds December 1: CIIC – Providing a Shared Repository of Detailed Clinical Models for all of Health and Healthcare (Stanley M. Huff, MD; W. Ed Hammond, PhD)

    Featured December 1, 2017 @ 1:00 pm - 2:00 pm
    https://dukemed.webex.com/dukemed/j.php?MTID=m4c6e3e4827442a92338a5649cee613e6

    Speakers: Stanley M. Huff, MD Chief Medical Informatics Officer Intermountain Healthcare and Professor (Clinical) of Biomedical Informatics University of Utah W. Ed Hammond, PhD Duke Center for Health Informatics Clinical […]

  • Fri 8

    Grand Rounds December 8, 2017: Data and Safety Monitoring in Pragmatic Clinical Trials (Greg Simon, MD, MPH; Jeremy Sugarman, MD, MPH, MA; Susan Ellenberg, PhD)

    Featured December 8, 2017 @ 1:00 pm - 2:00 pm
    https://dukemed.webex.com/dukemed/j.php?MTID=m4c6e3e4827442a92338a5649cee613e6

    Speakers: Greg Simon, MD, MPH Senior Investigator Kaiser Permanente Washington Health Research Institute Jeremy Sugarman, MD, MPH, MA Harvey M. Meyerhoff Professor of Bioethics and Medicine Johns Hopkins Berman Institute of Bioethics Susan S. Ellenberg, PhD Professor of Biostatistics Professor of Medical Ethics and Health Policy Department of Biostatistics, Epidemiology and Informatics, Perelman School of […]

  • Fri 15

    Grand Rounds December 15: Does Machine Learning Have a Place in a Learning Health System? (Michael Pencina, PhD)

    Featured December 15, 2017 @ 1:00 pm - 2:00 pm
    https://dukemed.webex.com/dukemed/j.php?MTID=m4c6e3e4827442a92338a5649cee613e6

    Speaker: Michael Pencina, PhD Professor of Biostatistics and Bioinformatics, Duke University Director of Biostatistics Duke Clinical Research Institute Topic: Does machine learning have a place in a learning health system Date: Friday, December 15, 2017, 1:00-2:00 p.m. ET Meeting Info: To check whether you have the appropriate players installed for UCF (Universal Communications Format) rich […]

  • Fri 22

    Grand Rounds December 22: No Presentation (Holiday Weekend)

    December 22, 2017 @ 1:00 pm - 2:00 pm
    https://dukemed.webex.com/dukemed/j.php?MTID=m4c6e3e4827442a92338a5649cee613e6

    Grand Rounds December 22: No Presentation (Holiday Weekend) We hope to see you next week.

  • Fri 29

    Grand Rounds December 29: No Presentation (Holiday Weekend)

    December 29, 2017 @ 1:00 pm - 2:00 pm
    https://dukemed.webex.com/dukemed/j.php?MTID=m4c6e3e4827442a92338a5649cee613e6

    Grand Rounds December 29: No Presentation (Holiday Weekend) We hope to see you next week.

  • January 2018

  • Fri 5

    Grand Rounds January 5: IMPACT-AFib: An 80,000 person Randomized Trial Using the Sentinel Initiative Platform (Noelle M. Cocoros, DSc, MPH; Christopher B. Granger, MD, FACC, FAHA; Richard Platt MD, MS; Sean Pokorney, MD)

    Featured January 5, 2018 @ 1:00 pm - 2:00 pm
    https://dukemed.webex.com/dukemed/j.php?MTID=m4c6e3e4827442a92338a5649cee613e6

    Speakers: Noelle M. Cocoros, DSc, MPH Epidemiologist, Department of Population Medicine Harvard Medical School and Harvard Pilgrim Health Care Institute Christopher B. Granger, MD, FACC, FAHA Professor of Medicine, Duke University Director, Cardiac Care Unit Duke University Medical Center Richard Platt, MD, MS Professor and Chair, Department of Population Medicine Harvard Medical School and Harvard […]

  • Fri 12

    Grand Rounds January 12: Behavioral Economic Principles to Understand and Change Clinician Behavior (Jeffrey A. Linder, MD, MPH, FACP)

    Featured January 12, 2018 @ 1:00 pm - 2:00 pm
    https://dukemed.webex.com/dukemed/j.php?MTID=m4c6e3e4827442a92338a5649cee613e6

    Speaker: Jeffrey A. Linder, MD, MPH, FACP Chief, Division of General Internal Medicine and Geriatrics Michael A. Gertz Professor of Medicine Northwestern University Feinberg School of Medicine Topic: Behavioral Economic Principles to Understand and Change Clinician Behavior Date: Friday, January 12, 2018, 1:00-2:00 p.m. ET Meeting Info: To check whether you have the appropriate players […]

  • Fri 19

    Grand Rounds January 19: The Healthcare Pivot: Technology and Transformation of Healthcare (Kevin A. Schulman, MD)

    Featured January 19, 2018 @ 1:00 pm - 2:00 pm
    https://dukemed.webex.com/dukemed/j.php?MTID=m4c6e3e4827442a92338a5649cee613e6

    Speaker: Kevin A. Schulman, MD Professor of Medicine Associate Director, Duke Clinical Research Institute Visiting Scholar, Harvard Business School Topic: The Healthcare Pivot: Technology and Transformation of Healthcare Date: Friday, […]

  • Fri 26

    Grand Rounds January 26: The Lumbar Imaging with Reporting of Epidemiology (LIRE) Trial: Subsequent Cross-Sectional Imaging Through 90 Days- Preliminary Results (Jeffrey Jarvik, MD, MPH; Patrick Heagerty, PhD)

    Featured January 26, 2018 @ 1:00 pm - 2:00 pm
    https://dukemed.webex.com/dukemed/j.php?MTID=m4c6e3e4827442a92338a5649cee613e6

    Speakers: Jeffrey (Jerry) G. Jarvik MD MPH Professor, Radiology, Neurological Surgery and Health Services Adjunct Professor, Pharmacy and Orthopedics & Sports Medicine Co-Director, Comparative Effectiveness, Cost and Outcomes Research Center Director, UW CLEAR Center for Musculoskeletal Disorders University of Washington Patrick J. Heagerty PhD Gilbert S. Omenn Endowed Chair in Biostatistics Professor and Chair, Department of Biostatistics University […]

  • February 2018

  • Fri 2

    Grand Rounds February 2: Early Progress on the All of Us Research Program (Joshua C. Denny, MD, MS, FACMI)

    Featured February 2, 2018 @ 1:00 pm - 2:00 pm
    https://dukemed.webex.com/dukemed/j.php?MTID=m4c6e3e4827442a92338a5649cee613e6

    Speaker: Joshua C. Denny, MD, MS, FACMI Professor of Biomedical Informatics and Medicine Director, Center for Precision Medicine Vice President for Personalized Medicine Vanderbilt University Medical Center Topic: Early Progress […]

  • Fri 9

    Grand Rounds February 9: Linking Design to Analysis of Cluster Randomized Trials: Covariate Balancing Strategies (Fan Li, PhD)

    Featured February 9, 2018 @ 1:00 pm - 2:00 pm
    https://dukemed.webex.com/dukemed/j.php?MTID=m4c6e3e4827442a92338a5649cee613e6

    Speaker: Fan Li, PhD Candidate in Biostatistics Department of Biostatistics and Bioinformatics Duke University Topic: Linking Design to Analysis of Cluster Randomized Trials: Covariate Balancing Strategies Date: Friday, February 9, 2018, […]

  • Fri 16

    Grand Rounds February 16: Considerations for the Return of Genomic Results (Heidi Rehm, PhD, FACMG; W. Andrew Faucett, MS, LGC)

    Featured February 16, 2018 @ 1:00 pm - 2:00 pm
    https://dukemed.webex.com/dukemed/j.php?MTID=m4c6e3e4827442a92338a5649cee613e6

    Speakers: Heidi Rehm, PhD, FACMG Associate Professor of Pathology Brigham & Women's Hospital and Harvard Medical School W. Andrew (Andy) Faucett, MS, LGC Professor Director of Policy and Education Office of the Chief Scientific Officer Geisinger Topic: Considerations for the Return of Genomic Results Date: Friday, February 16, 2018, 1:00-2:00 p.m. ET Meeting Info: To […]

  • Fri 23

    Grand Rounds February 23: Direct Mail Programs Work… But Will Health Centers Implement Them? Findings from STOP CRC (Gloria D. Coronado, PhD; Beverly B. Green, MD, MPH)

    Featured February 23, 2018 @ 1:00 pm - 2:00 pm
    https://dukemed.webex.com/dukemed/j.php?MTID=m4c6e3e4827442a92338a5649cee613e6

    Speakers: Gloria D. Coronado, PhD Senior Investigator Mitch Greenlick Endowed Scientist for Health Disparities Kaiser Permanente Center for Health Research Beverly B. Green, MD, MPH Associate Investigator Kaiser Permanente Washington Health Research Institute Topic: Direct Mail Programs Work… But Will Health Centers Implement Them? Findings from STOP CRC Date: Friday, February 23, 2018, 1:00-2:00 p.m. […]

  • March 2018

  • Fri 2

    Grand Rounds March 2: Distributed Research Network Querying: A Status Report (Jeff Brown, PhD; Lesley H. Curtis, PhD; Richard Platt, MD, MSc)

    Featured March 2, 2018 @ 1:00 pm - 2:00 pm
    https://dukemed.webex.com/dukemed/j.php?MTID=m4c6e3e4827442a92338a5649cee613e6

    Speakers: Jeff Brown, PhD Associate Professor, Department of Population Medicine Harvard Pilgrim Health Care Institute Lesley H. Curtis, PhD Professor of Medicine Director, Center for Population Health Sciences, Duke School of Medicine Director, Center for Pragmatic Health Systems Research, Duke Clinical Research Institute Richard Platt, MD, MS Professor and Chair, Department of Population Medicine Harvard […]

  • Tue 6

    March 6-7: Real-World Evidence Workshop Series- Workshop 2: Practical Approaches

    Featured March 6, 2018 @ 8:00 am - March 7, 2018 @ 12:30 pm

    The National Academies of Sciences, Engineering, and Medicine (National Academies) is convening the second workshop in a three-part series examining how real-world evidence development and uptake can enhance medical product development and evaluation. The workshops will advance discussions and common knowledge about complex issues relating to the generation and utilization of real-world evidence, including fostering […]

  • Wed 7

    March 7, 2018: PCORnet Best Practice Sharing Session: Lessons Learned in ADAPTABLE

    Featured March 7, 2018 @ 2:00 pm - 3:00 pm

    PCORnet Best Practice Sharing Session – Lessons Learned in ADAPTABLE: Recruitment, Retention, and Endpoint Ascertainment Join WebEx meeting: https://dukemed.webex.com/dukemed/j.php?MTID=m350d72f769538a3c056d0835692bae2a Phone: 1-650-479-3207 / Meeting Number (access code): 730 973 890 Speakers: Schuyler Jones, MD, and Holly Robertson, PhD More information on PCORnet Website: http://pcornet.org/event/pcornet-best-practice-sharing-session-lessons-learned-adaptable-recruitment-retention-endpoint-ascertainment/ All are welcome to attend! For those unable to join, the meeting […]

  • Fri 9

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    Featured March 9, 2018 @ 1:00 pm - 2:00 pm
    https://dukemed.webex.com/dukemed/j.php?MTID=m4c6e3e4827442a92338a5649cee613e6

    Speakers: Eric B. Larson, MD, MPH Vice President, Research and Health Care Innovation Kaiser Foundation Health Plan of Washington Executive Director and Senior Investigator Kaiser Permanente Washington Health Research Institute Paula Lozano, MD, MPH Associate Medical Director for Research and Translation Senior Investigator Kaiser Permanente Washington Health Research Institute Joan DeClaire Director, Communications Kaiser Permanente […]

  • Fri 16

    Grand Rounds March 16: Straight from the Source: Clinicians’ Views on Participating in CER/PCOR (Ellen Tambor, MA; Rachael Moloney, MHS; Sean Tunis, MD, MSc)

    Featured March 16, 2018 @ 1:00 pm - 2:00 pm
    https://dukemed.webex.com/dukemed/j.php?MTID=m4c6e3e4827442a92338a5649cee613e6

    Speakers: Ellen Tambor, MA Research Director Center for Medical Technology Policy (CMTP) Rachael Moloney, MHS Research Manager Center for Medical Technology Policy (CMTP) Sean Tunis, MD, MSc President and CEO Center for Medical Technology Policy (CMTP) Topic: Straight from the Source: Clinicians’ Views on Participating in CER/PCOR Date: Friday, March 16, 2018, 1:00-2:00 p.m. ET […]

  • Mon 19

    March 19: OHDSI: FDA Workshop: Developing & Submitting Proposed Draft Guidance on Patient Experience Data

    Featured March 19, 2018 @ 1:00 pm - 5:00 pm

    Topic: FDA Workshop: Developing & Submitting Proposed Draft Guidance on Patient Experience Data The purpose of this public workshop is to obtain input from stakeholders on considerations for development and submission of proposed draft guidance relating to patient experience data submitted by an external stakeholder, including: Defining the scope of the proposed draft guidance Developing […]

  • Fri 23

    Grand Rounds March 23: Data Science in the Era of Data Ubiquity (Robert M. Califf, MD)

    Featured March 23, 2018 @ 1:00 pm - 2:00 pm
    https://dukemed.webex.com/dukemed/j.php?MTID=m4c6e3e4827442a92338a5649cee613e6

    Speaker: Robert M. Califf, MD Vice Chancellor for Health Data Science Duke University Advisor, Verily Life Sciences Topic: Data Science in the Era of Data Ubiquity Date: Friday, March 23, 2018, 1:00-2:00 p.m. ET Meeting Info: To check whether you have the appropriate players installed for UCF (Universal Communications Format) rich media files, go to […]

  • Fri 30

    Grand Rounds March 30: HHS-DoD-VA Pain Management Collaboratory (Robert Kerns, PhD)

    Featured March 30, 2018 @ 1:00 pm - 2:00 pm
    https://dukemed.webex.com/dukemed/j.php?MTID=m4c6e3e4827442a92338a5649cee613e6

    Speaker: Robert D. Kerns, PhD Professor of Psychiatry, Neurology, and Psychology Yale University Topic: HHS-DoD-VA Pain Management Collaboratory Date: Friday, March 30, 2018, 1:00-2:00 p.m. ET Meeting Info: To check whether you have the appropriate players installed for UCF (Universal Communications Format) rich media files, go to https://dukemed.webex.com/dukemed/systemdiagnosis.php. To join the online meeting: Go to […]

  • April 2018

  • Fri 6

    Grand Rounds April 6: Legal and Ethical Architecture for PCOR Data (Jane Hyatt Thorpe, JD; Lara Cartwright-Smith, JD, MPH; Elizabeth Gray, JD, MHA)

    Featured April 6, 2018 @ 1:00 pm - 2:00 pm
    https://dukemed.webex.com/dukemed/j.php?MTID=m4c6e3e4827442a92338a5649cee613e6

    Speakers: Jane Hyatt Thorpe, JD Associate Professor Department of Health Policy and Management Milken Institute School of Public Health George Washington University Lara Cartwright-Smith, JD, MPH Associate Research Professor Department of Health Policy and Management Milken Institute School of Public Health George Washington University Elizabeth Gray, JD, MHA Research Scientist Department of Health Policy and […]

  • Fri 13

    Grand Rounds April 13: OHDSI: Drawing Reproducible Conclusions from Observational Clinical Data (George Hripcsak, MD, MS)

    Featured April 13, 2018 @ 1:00 pm - 2:00 pm
    https://dukemed.webex.com/dukemed/j.php?MTID=m4c6e3e4827442a92338a5649cee613e6

    Speaker: George Hripcsak, MD, MS Vivian Beaumont Allen Professor of Biomedical Informatics, Columbia University Chair, Department of Biomedical Informatics, Columbia University Director, Medical Informatics Services, NewYork-Presbyterian Hospital/Columbia Topic: OHDSI: Drawing Reproducible Conclusions from Observational Clinical Data Date: Friday, April 13, 2018, 1:00-2:00 p.m. ET Meeting Info: To check whether you have the appropriate players installed for UCF […]

  • Fri 20

    Grand Rounds April 20: The Trauma Survivors Outcomes and Support (TSOS) Trial as an ePCT Training Case Study (Doug Zatzick, MD)

    Featured April 20, 2018 @ 1:00 pm - 2:00 pm
    https://dukemed.webex.com/dukemed/j.php?MTID=m4c6e3e4827442a92338a5649cee613e6

    Speaker: Doug Zatzick, MD TSOS Principal Investigator Professor, Department of Psychiatry and Behavioral Sciences University of Washington School of Medicine Topic: The Trauma Survivors Outcomes and Support (TSOS) Trial as an ePCT Training Case Study Date: Friday, April 20, 2018, 1:00-2:00 p.m. ET Meeting Info: To check whether you have the appropriate players installed for […]

  • Tue 24

    NIH Mind the Gap Webinar: Design and Analysis of Individually Randomized Group-Treatment Trials in Public Health

    Featured April 24, 2018 @ 11:00 am - 12:00 pm
    https://dukemed.webex.com/dukemed/j.php?MTID=m4c6e3e4827442a92338a5649cee613e6

    Speaker Sherri Pals, PhD. Mathematical Statistician at the Centers for Disease Control and Prevention (CDC). Dr. Pals will accept questions during the webinar via WebEx and Twitter. Use the hashtag #NIHMtG. About This Webinar Individually randomized group-treatment (IRGT) trials are studies in which individual participants are randomly assigned to study conditions, but treatment is administered in […]

  • Fri 27

    Grand Rounds April 27: Expanding Use of Real-World Evidence, a National Academies Workshop Series (Greg Simon, MD, MPH)

    Featured April 27, 2018 @ 1:00 pm - 2:00 pm
    https://dukemed.webex.com/dukemed/j.php?MTID=m4c6e3e4827442a92338a5649cee613e6

    Speaker: Greg Simon, MD, MPH Senior Investigator Kaiser Permanente Washington Health Research Institute Topic: Expanding Use of Real-World Evidence, a National Academies Workshop Series Date: Friday, April 27, 2018, 1:00-2:00 p.m. ET Meeting Info: To check whether you have the appropriate players installed for UCF (Universal Communications Format) rich media files, go to https://dukemed.webex.com/dukemed/systemdiagnosis.php. To […]

  • May 2018

  • Fri 4

    Grand Rounds May 4: Leveraging Community Engagement and Informatics-Based Tools to Increase Participant Recruitment and Retention (Paul A. Harris, PhD; Consuelo H. Wilkins, MD, MSCI; Patricia Jones, DrPH, MPH)

    Featured May 4, 2018 @ 1:00 pm - 2:00 pm
    https://dukemed.webex.com/dukemed/j.php?MTID=m4c6e3e4827442a92338a5649cee613e6

    Speakers: Paul A. Harris, PhD Director, Office of Research Informatics Professor, Department of Biomedical Informatics & Department of Biomedical Engineering Vanderbilt University Consuelo H. Wilkins, MD, MSCI Executive Director, Meharry-Vanderbilt Alliance Patricia Jones, DrPH, MPH Program Director National Center for Advancing Translational Sciences (NCATS) Topic: Leveraging Community Engagement and Informatics-Based Tools to Increase Participant Recruitment […]

  • Wed 9

    Advancing the Science of Patient Input in Medical Product R&D: Towards A Research Agenda

    Featured May 9, 2018 @ 8:30 am - 5:00 pm

    About This Webcast  Converting traditionally anecdotal patient input into rigorous, credible evidence for use by a broad range of stakeholders could better align medical product research and development (R&D) and regulatory decision-making with patient experience of and preferences for disease management and treatment. Accordingly, many efforts have been launched to advance a science of patient input—the […]

  • Fri 11

    Grand Rounds May 11: Launching the NESTcc Data Network to Improve the use of Real-World Evidence in the Medical Device Ecosystem (Rachael Fleurence, PhD)

    Featured May 11, 2018 @ 1:00 pm - 2:00 pm
    https://dukemed.webex.com/dukemed/j.php?MTID=m4c6e3e4827442a92338a5649cee613e6

    Speaker: Rachael Fleurence, PhD Executive Director, National Evaluation System for health Technology Coordinating Center (NESTcc) Medical Device Innovation Consortium (MDIC) Topic: Launching the NESTcc Data Network to Improve the use of Real-World Evidence in the Medical Device Ecosystem Date: Friday, May 11, 2018, 1:00-2:00 p.m. ET Meeting Info: To check whether you have the appropriate […]

  • Wed 16

    Embedded Pragmatic Clinical Trials of Therapeutic A vs. B Interventions Workshop

    Featured May 16, 2018 @ 8:00 am - 4:15 pm

      About This Event  Organizing Committee: Adrian Hernandez & Richard Platt (Co-Chairs), Laura Dember, Leslie Derr, Susan Huang, Catherine Meyers, Wendy Weber and Dave Wendler This one-day workshop will explore challenges and strategies for planning and implementing embedded pragmatic clinical trials (PCT) that compare two or more therapeutic medical regimens. Pragmatic trials differ from traditional […]

  • Fri 18

    Grand Rounds May 18: The PCORnet Antibiotics and Childhood Growth Study: Using PCORnet Data for Longitudinal Observational Research (Christopher Forrest, MD, PhD; L. Charles Bailey, MD, PhD; Jason Block, MD, MPH)

    Featured May 18, 2018 @ 1:00 pm - 2:00 pm
    https://dukemed.webex.com/dukemed/j.php?MTID=m4c6e3e4827442a92338a5649cee613e6

    Speakers: Christopher B. Forrest, MD, PhD Professor, Pediatrics & Health Care Management PI, PEDSnet, A National Pediatric Learning Health System Director, Center for Applied Clinical Research, Children's Hospital of Philadelphia and University of Pennsylvania L. Charles Bailey, MD, PhD Associate Professor of Clinical Pediatrics Perelman School of Medicine Children's Hospital of Philadelphia and University of […]

  • June 2018

  • Fri 1

    Grand Rounds June 1: How Would You Build an Academic Medical System to Bridge Research and Care if You Could Start from Scratch? (S. Claiborne “Clay” Johnston, MD, PhD, MPH)

    June 1, 2018 @ 1:00 pm - 2:00 pm

    Speakers: S. Claiborne “Clay” Johnston, MD, PhD, MPH Dean and Vice President for Medical Affairs Dell Medical School, The University of Texas at Austin Topic: How Would You Build an […]

  • Fri 8

    Grand Rounds June 8: Implementation in the PROVEN Trial: Challenges of Conducting PCTs in Nursing Home Health Care Systems (Susan Mitchell MD, MPH; Angelo Volandes, MD, MPH)

    Featured June 8, 2018 @ 1:00 pm - 2:00 pm
    https://dukemed.webex.com/dukemed/j.php?MTID=m4c6e3e4827442a92338a5649cee613e6

    Speakers: Susan Mitchell, MD, MPH Senior Scientist, Institute for Aging Research, Hebrew Senior Life Professor of Medicine, Harvard Medical School Angelo Volandes, MD, MPH Associate Professor of Medicine, Harvard Medical […]

  • Fri 15

    Grand Rounds June 15: Research at Scale – Exploring What is Possible with High-Quality Real-World Data. Examples from Flatiron Health. (Amy P. Abernethy, MD, PhD)

    Featured June 15, 2018 @ 1:00 pm - 2:00 pm
    https://dukemed.webex.com/dukemed/j.php?MTID=m4c6e3e4827442a92338a5649cee613e6

    Speaker: Amy P. Abernethy, MD, PhD Chief Medical Officer, Chief Scientific Officer, SVP Oncology Flatiron Health Topic: Research at Scale - Exploring What is Possible with High-Quality Real-World Data. Examples […]

  • Fri 22

    Grand Rounds June 22: Pragmatic Trial Design to Study Health Policy Interventions: Lessons Learned from ARTEMIS (Tracy Y. Wang, MD, MHS, MSc)

    June 22, 2018 @ 1:00 pm - 2:00 pm

    Speaker: Tracy Y. Wang, MD, MHS, MSc Director, DCRI Health Service Research Fellowship Associate Program Director Associate Professor of Medicine, Cardiology Duke University Medical Center Topic: Pragmatic Trial Design to Study […]

  • Fri 29

    Grand Rounds June 29: Policy & Priorities: Rethinking University Research with State Data (Aaron McKethan, PhD)

    June 29, 2018 @ 1:00 pm - 2:00 pm

    Speaker: Aaron McKethan, PhD Assistant Professor of Population Health Sciences, Duke School of Medicine Senior Policy Fellow, Duke-Margolis Center for Health Policy Chief Data Officer, NC DHHS Topic: Policy & […]

  • July 2018

  • Fri 6

    Grand Rounds July 6th: No Presentation (Week of July 4th Holiday)

    July 6, 2018 @ 1:00 pm - 2:00 pm

    Grand Rounds July 6th: No Presentation (In observance of July 4th holiday) We hope to see you next week.

  • Tue 10

    Report Release Webinar: Returning Individual Research Results to Participants

    July 10, 2018 @ 11:00 am - 12:00 pm
    https://dukemed.webex.com/dukemed/j.php?MTID=m4c6e3e4827442a92338a5649cee613e6

    Register now! Report release for Returning Individual Research Results to Participants When is it appropriate to return individual research results to participants? What are the risks and benefits of the practice […]

  • Wed 11

    Mind The Gap NIH Webinar Series: Stepped Wedge Cluster Randomized Designs for Disease Prevention Research

    July 11, 2018 @ 11:00 am - 12:00 pm

    About This Webinar  The stepped wedge cluster randomized design has seen a rapid increase in popularity over the past decade. It is different than the conventional parallel arm cluster randomized […]

  • Fri 13

    Grand Rounds July 13: Clinical Trial Data Sharing: Perspectives from Participants and PCORI

    July 13, 2018 @ 1:00 pm - 2:00 pm

    Speakers: Michelle M. Mello, JD, PhD Professor of Law, Stanford Law School Professor of Health Research and Policy, Stanford University School of Medicine Steven Goodman, MD, MHS, PhD Associate Dean, […]

  • Fri 20

    Grand Rounds July 20: Developing Technology-Derived Novel Endpoints for use in Clinical Trials: Recommendations and Case Examples from the Clinical Trials Transformation Initiative

    July 20, 2018 @ 1:00 pm - 2:00 pm

    Speakers: Will Herrington, MA, MBBS, MD, MRCP MRC-Kidney Research UK Professor and David Kerr Clinician Scientist Nuffield Department of Population Health, University of Oxford Rob DiCicco, PharmD Principal Consultant TransCelerate […]

  • Fri 27

    Grand Rounds July 27: Pilot Study for a Pragmatic Trial Comparing Chlorthalidone and Hydrochlorothiazide: Results and Lessons Learned

    July 27, 2018 @ 1:00 pm - 2:00 pm

    Speakers: Karen Margolis, MD, MPH HealthPartners Institute, Minneapolis, MN Stephen Fortmann, MD Kaiser Permanente Center for Health Research, Portland, OR Topic: Pilot Study for a Pragmatic Trial Comparing Chlorthalidone and […]

  • August 2018

  • Fri 3

    Grand Rounds August 3: A Digital Pragmatic Direct-to-Participant Clinical Trial for Identifying Undiagnosed Atrial Fibrillation in a Large Health Plan Population

    August 3, 2018 @ 1:00 pm - 2:00 pm

    Speaker: Steven R. Steinhubl, MD Director of Digital Medicine, Scripps Research Translational Institute Associate Professor, Molecular Medicine, Scripps Research Topic: A Digital Pragmatic Direct-to-Participant Clinical Trial for Identifying Undiagnosed Atrial […]

  • Fri 10

    Grand Rounds August 10: Using a Novel mHealth Platform to Obtain Real-World Data for Post-Market Surveillance: A NEST NIH Collaboratory Trial

    August 10, 2018 @ 1:00 pm - 2:00 pm

    Speaker: Sanket Dhruva, MD, MHS Assistant Professor of Clinical Medicine, UCSF School of Medicine Cardiologist, San Francisco VA Medical Center Topic: Using a Novel mHealth Platform to Obtain Real-World Data for […]

  • Fri 17

    Grand Rounds August 17: The PCORnet Bariatric Study: Preliminary Results from a Large PCORnet NIH Collaboratory Trial

    August 17, 2018 @ 1:00 pm - 2:00 pm

    Speakers: David Arterburn, MD, MPH Kaiser Permanente Washington Kathleen McTigue, MD, MPH University of Pittsburgh Medical Center Neely Williams, Mdiv Patient Collaborator, Mid-South CDRN Laura Rasmussen-Torvik, PhD Northwestern Medicine Topic: […]

  • Fri 24

    Grand Rounds August 24: FoodSwitch USA: A Mobile Platform for Packaged Food Surveillance and Behavioral Research

    August 24, 2018 @ 1:00 pm - 2:00 pm

    Speaker: Mark Huffman, MD, MPH Associate Professor of Preventive Medicine and Medicine-Cardiology Northwestern University Feinberg School of Medicine Topic: FoodSwitch USA: A Mobile Platform for Packaged Food Surveillance and Behavioral […]

  • September 2018

  • Fri 7

    Grand Rounds September 7: NIH Collaboratory: Research Transformation in Progress

    September 7, 2018 @ 1:00 pm - 2:00 pm

    Speakers: Adrian F. Hernandez, MD, MHS Professor of Medicine Vice Dean for Clinical Research Duke University School of Medicine Kevin Weinfurt, PhD Professor and Vice Chair for Research Department of […]

  • Fri 14

    Grand Rounds September 14: Advancing the Use of Mobile Technologies for Data Capture & Improved Clinical Trials

    September 14, 2018 @ 1:00 pm - 2:00 pm

    Speakers: John Hubbard, Ph.D., FCP Strategic Advisory Board, Genstar Capital Barry Peterson, Ph.D Independent Consultant Cheryl A. Grandinetti, Pharm.D. Office of Compliance, Office of Scientific Investigations, Division of Clinical Compliance […]

  • Fri 21

    Grand Rounds September 21: Returning Individual Research Results to Participants: Guidance for a New Research Paradigm

    September 21, 2018 @ 1:00 pm - 2:00 pm

    Speakers: Jeffrey R. Botkin, M.D., M.P.H. Associate Vice President for Research Professor of Pediatrics University of Utah School of Medicine Consuelo H. Wilkins, M.D., MSCI Associate Professor of Medicine Vanderbilt […]

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