trial onboarding

April 2022 Steering Committee Meeting

Steering Committee Meeting

April 20-21, 2022

Bethesda, MD

Main Purpose

Celebrate 10 years of the Collaboratory program with discussions on the evolution and current landscape of embedded pragmatic clinical trials (ePCTs); share thoughts on priorities for the future of ePCTs, including how to better serve diverse populations; hear updates on progress and transition plans, as well as challenges and lessons learned, from the UG3 NIH Collaboratory Trials; and learn about the latest bioethics activities in the NIH Collaboratory.

Wednesday, April 20, 2022

Welcome and Opening Remarks

Helene Langevin, MD, PhD; Richard Hodes, MD; Lesley Curtis, PhD

Keynote Panel

Celebrate the success of the Collaboratory and describe the roadmap for its future

Moderator: Josie Briggs, MD

  • Cathy Meyers, MD
  • Wendy Weber, ND, PhD, MPH

Then, Now, and the Future…

Moderator: Adrian Hernandez, MD, MHS

The NIH's perspective on how the Collaboratory has propelled embedded pragmatic research throughout the NIH

This panel of contributors from throughout the Collaboratory's history will discuss the program's influence on the evolution of ePCTs over the past decade, including methodologic advances, surprising takeaways, and best practices generated from supporting over 20 large-scale trials within health systems.

Looking at the Landscape of National ePCT Initiatives

Presentations on lessons learned from the Collaboratory and the work of other ongoing pragmatic trial programs

Navigating the Challenges of Including Diverse Participants

Panel discussion questions:
1. Are ePCTs answering questions that are high priority for health systems that serve diverse patient populations?
2. How can we build capacity and infrastructure across institutions with fewer resources?
3. How do we develop a pipeline of diverse investigators across diverse sites?

Moderator: Rosa Gonzalez-Guarda, PhD, MPH, RN, CPH, FAAN

  • Karen Kehl, PhD, RN, FPCN
  • Rachel Gold, PhD, MPH
  • Julie Fritz, PhD, PT
  • Natalia Morone, MD
  • Mitch Knisely, PhD, RN-BC, ACNS-BC
  • Gloria Coronado, PhD

Discussion From New UG3 NIH Collaboratory Trial: Implementation of the American College of Physicians Guideline for Low Back Pain (IMPACt‑LBP)

Update on lessons learned from Year 1, ongoing transition issues, sustainability for the UH3 phase, and any challenges. Discuss the UG3’s current data sharing plans.

Christine Goertz, DC, PhD; Adam Goode, PT, DPT, PhD; Jon Lurie, MD, MS; Hrishikesh Chakraborty, DrPH

Closing Remarks/Adjourn

Helene Langevin, MD, PhD; Richard Hodes, MD; Lesley Curtis, PhD

10th Anniversary Celebration

Highlights slides

Posters

 

Thursday, April 21, 2022

Welcome and Opening Remarks

Helene Langevin, MD, PhD; David Shurtleff, PhD; Richard Hodes, MD; Lesley Curtis, PhD

Perspectives From Our Federal Partners

U.S. Food and Drug Administration

Discuss how to generate evidence at a very large scale, especially for chronic health conditions like pain management

  • Rob Califf, MD

Centers for Medicare & Medicaid Services

  • Lee Fleisher, MD

HHS OS-Patient-Centered Outcomes Research Trust Fund

Share projects that may be of interest to Collaboratory investigators such as data linkages and social determinants of health data

  • Nancy DeLew, MA, MPA

Unanticipated Challenges

The NIH Collaboratory Trials on this panel encountered unanticipated challenges that caused them to change the randomization scheme of their trial. With the help of the Biostatistics and Study Design Core, we will explore the challenges, solutions, and lessons learned as part of this process.

Moderators: Patrick Heagerty, PhD; David Murray, PhD

Barriers and Challenges: Patient, Clinician, and Healthcare System Engagement

Of all the activities in ePCTs, patient, clinician, and healthcare system engagement is continuously ranked one of the most challenging by NIH Collaboratory Trials. Enrollment and engagement of participants is hard, as is engaging with clinicians, providers, and healthcare systems’ leaders throughout the life cycle of a study. We will discuss challenges encountered and solutions for engaging stakeholders to ensure a successful trial.

Moderator: Eric Larson, MD, MPH

Barriers and Challenges: Data Collection and Merging Data Sets

Collecting and aggregating data from diverse data sets, including the electronic health record, patient-report outcomes, and claims data, involves many expected and unexpected challenges. We will learn about the data-related barriers encountered by NIH Collaboratory Trials, their solutions, and their suggestions for future trials.

Moderator: Keith Marsolo, PhD

Barriers and Challenges: Implementing/Delivering Interventions Across Healthcare Organizations and Stability of Control

Successfully implementing and delivering an intervention across multiple organizations is dependent on many factors, including the complexity of the intervention, the stability of the control, and barriers to and promoters of uptake. We will learn from the NIH Collaboratory Trials’ experiences with implementation.

Moderator: Steven George, PhD

  • PRIM-ER: Corita Grudzen, MD, MSHS, FACEP
  • GRACE: Mitch Knisely, PhD, RN-BC, ACNS-BC
  • ACP PEACE: James Tulsky, MD
  • BackInAction: Karen Sherman, PhD, MPH

Bioethics Supplement Activities

An update on the activities of the Bioethics Supplement

Stephanie Morain, PhD

Closing Remarks

Helene Langevin, MD, PhD; Richard Hodes, MD; Lesley Curtis, PhD

NIH-Hosted Workshop: Critical Questions for Pragmatic Clinical Trialists: Insights From the NIH Pragmatic Trials Collaboratory’s First Decade

This 2-day workshop held during June 2022 is an opportunity to glean the most salient lessons learned from an experienced group of pragmatic trial investigators who openly shared the challenges they have encountered, solutions they have developed, and thoughts for the future. 

April 2021 Steering Committee Meeting

Steering Committee Meeting

April 14-15, 2021

Virtual

Main Purpose

To discuss important considerations for Collaboratory trials and the embedded pragmatic clinical trial ecosystem at large, including adaptations made due to COVID-19, data sharing models and experiences, barriers encountered, and lessons learned.

Wednesday, April 14, 2021

Welcome and Opening Remarks

Helene Langevin, MD, PhD; Richard Hodes, MD; Lesley Curtis, PhD

Keynote Panel

Discussion of learnings from the RECOVERY platform and implications for embedded PCTs

Martin Landray, PhD

High-Level Overview: Impact of COVID-19 on Collaboratory Projects

Discussion of the overarching impacts of COVID-19 on the NIH Collaboratory Trials and support provided by the Coordinating Center

Emily O'Brien, PhD

Barriers, Challenges, and Opportunities Encountered From COVID-19 and Lessons Learned from the UH3s

Changes in Study Design and Analysis

Moderated discussion about adaptations to design, measurement, and analysis due to COVID-19

Moderator: Liz Turner, PhD

Panel:

    • ACP PEACE: James Tulsky, MD; Angelo Volandes, MD, MPH
    • PRIM-ER: Corita Grudzen, MD, MSHS
    • HiLo: Myles Wolf, MD

Changes in Study Conduct

Moderated discussion about transitions to virtual engagement and the impact on trials and research staffing due to COVID-19

Moderators: Eric Larson, MD; Rachel Richesson, PhD

Panel:

    • GGC4H: Margaret Kuklinski, PhD; Stacy Sterling, DrPH, MSW
    • OPTIMUM: Natalia Morone, MD
    • Nudge: Michael Ho, MD, PhD
    • BackInAction: Karen Sherman, PhD, MPH; Lynn DeBar, PhD, MPH
    • FM-TIPS: Kathleen Sluka, PT, PhD; Leslie Crofford, MD
    • EMBED: Ted Melnick, MD, MHS; Gail D’Onofrio, MD, MS
    • NOHARM: Andrea Cheville, MD; Jon Tilburt, MD

Reengineering Pragmatic Research for Future Pandemics

Discussion of how COVID-19 will impact research taking place during future pandemics

Adrian Hernandez, MD, MHS

Closing Remarks

Helene Langevin, MD, PhD; Richard Hodes, MD; Lesley Curtis, PhD

Thursday, April 15, 2021

Welcome and Opening Remarks

Helene Langevin, MD, PhD; Richard Hodes, MD; Lesley Curtis, PhD

Discussion From the UG3 NIH Collaboratory Trials

Update on the status of the UG3 efforts, transition issues, lessons learned, sustainability for the UH3 phase, and challenges

  • BeatPain Utah: Julie Fritz, PhD, PT
  • GRACE: Ardith Z. Doorenbos, PhD, RN; Robert E. Molokie, MD; Judith M. Schlaeger, PhD; Miriam O. Ezenwa, PhD, RN; Nirmish Shah, MD

Data Sharing and the Privacy and Consent Implications for Collaboratory

Discussion of privacy and consent issues that influence data sharing, including impacts on the NIH Collaboratory and HEAL projects

Data Sharing Requirements for NIH ClinicalTrials.gov and PRISM Collaboratory

Review of current data sharing policies for HCS Collaboratory and PRISM Collaboratory (under the HEAL Initiative) and discussion of the differences between the policies

Closing Remarks

Helene Langevin, MD, PhD; Richard Hodes, MD; Kevin Weinfurt, PhD

NIH-Hosted Workshop: Inclusion of Diverse Participants in Pragmatic Clinical Trials

This 6-part workshop series held from May to August 2021 focuses on the inclusion of diverse participants in pragmatic clinical trials with insights about planning for diversity, engaging participants, learning from implementation science to maximize diversity, and developing a pipeline of diverse investigators. View all 6 parts of the Inclusion of Diverse Participants in Pragmatic Clinical Trials workshop series.

 

November 9, 2020 Virtual Onboarding Meeting: BeatPain Utah and GRACE

PRISM Onboarding Meeting

November 9, 2020
Virtual

Main Purpose

Welcome the new PRISM UG3 NIH Collaboratory Trials; provide introductions, an overview of the Collaboratory Program and the NIH HEAL Initiative, hear from the new UG3 PRISM Projects; and discuss lessons learned from the Collaboratory Projects.

Welcome and Opening Remarks
Helene Langevin, MD, CM; Richard Hodes, MD; Lesley Curtis, PhD

Overview of the NIH HCS Research Collaboratory Program
Cathy Meyers, MD

HEAL Initiative Overview
Rebecca Baker, PhD

Overview of a HEAL Cooperative Agreement
Wendy Weber, ND, PhD, MPH; Laura Wandner, PhD

Discussion From New UG3 NIH Collaboratory Trials

  • GRACE
    Ardith Z. Doorenbos, PhD, RN; Robert E. Molokie, MD; Judith M. Schlaeger, PhD, CNM; Miriam O. Ezenwa, PhD, RN; Nirmish Shah, MD

Lessons Learned from Seasoned NIH Collaboratory Trials
Moderator: Lesley Curtis, PhD

Panel:
Jerry Jarvik, MD, MPH; Doug Zatzick, MD; Miguel Vazquez, MD; Mike Ho, MD, PhD; Karen Sherman, PhD, MPH; Natalia Morone, MD

Closing Remarks
Helene Langevin, MD, CM; Richard Hodes, MD; Lesley Curtis, PhD

April 2020 Steering Committee Meeting

Steering Committee Meeting

April 22-23, 2020

Virtual

Main Purpose

To discuss the embedded PCT (ePCT) ecosystem and its evolution, learn how to strengthen partnerships across the ecosystem, and identify approaches and lessons that will help inform and broaden the ecosystem.

Wednesday, April 22, 2020

Welcome and Opening Remarks

Helene Langevin, MD, PhD; Richard Hodes, MD; Lesley Curtis, PhD

The ePCT Ecosystem

Keynote Panel

Discuss the evolution of the ePCT ecosystem

Moderator: Kevin Weinfurt, PhD

Panel:
Josephine Briggs, MD
Catherine Meyers, MD
Wendy Weber, ND, PhD, MPH

The Current Landscape of ePCTs

Learn about the work of other ongoing pragmatic trial programs and discuss opportunities for cross-learning

Moderator: Lesley Curtis, PhD

Panel:
PCORI: Anne Trontell, MD, MPH
IMPACT Collaboratory: Marcel Salive, MD, MPH
Mental Health Research Network: Michael Freed, PhD
National Cancer Institute: Ashley Wilder Smith, PhD, MPH

Closing Remarks

Helene Langevin, MD, PhD; Richard Hodes, MD; Lesley Curtis, PhD

NIH-Hosted Workshop: Advances at the Intersection of Digital Health, EHRs, and PCTs

This 5-part workshop series held from May to July 2020 covered the ePCT ecosystem and its evolution in greater depth.  This is a workshop series highlighting advances in digital health, new approaches and evolving standards for EHRs, and implications for researchers conducting PCTs. View all 5 parts of the Advances at the Intersection of Digital Health, EHRs, and PCTs workshop series.

 

Thursday, April 23, 2020

Welcome and Opening Remarks

Helene Langevin, MD, PhD; Richard Hodes, MD; Lesley Curtis, PhD

Strengthening Partnerships in the ePCT Ecosystem

Food and Drug Administration

Discuss perspectives on generating real-world evidence and the importance of conducting ePCTs for knowledge dissemination and implementation

Moderator: Lesley Curtis, PhD

Speaker: Jacqueline Corrigan-Curay, JD, MD

Introduction to the Ecosystem Grid

Review the grid, identify trials we have learned from, and learn ways to broaden our ecosystem through different types of outcomes and settings

Speaker: Kevin Weinfurt, PhD

ClinicalTrials.gov

Learn about updates and modernization to ClinicalTrials.gov

Moderator: Catherine Meyers, MD, MPH

Speaker: Stacey Arnold, PhD

Informing the ePCT Ecosystem

Novel Approaches from the Collaboratory

Identify and highlight projects that have used innovative approaches

Moderator: Richard Platt, MD

Panel:
Michael Ho, MD
Vince Mor, PhD
Keith Marsolo, PhD

20:20 in 2020

Discuss lessons learned from trials that are completed or nearing completion, followed by a panel discussion on how we translate lessons learned into suggestions for strengthening the ecosystem

Moderator: Adrian Hernandez, MD, MHS

Panel:
Doug Zatzick, MD
Miguel Vazquez, MD
Vince Mor, PhD
Jerry Jarvik, MD, MPH
Lynn DeBar, PhD

Closing Remarks

Helene Langevin, MD, PhD; Richard Hodes, MD; Lesley Curtis, PhD

November 2019 Onboarding Meeting: NOHARM, OPTIMUM, FM TIPS, and AcuOA

PRISM Onboarding Meeting

November 19-20, 2019
Bethesda, MD

Main Purpose

To welcome the PRISM UG3 NIH Collaboratory Trials; provide introductions, an overview of the Collaboratory, and
an understanding of the Core Working Groups; and discuss lessons learned from the Collaboratory.

Tuesday, November 19, 2019

Welcome and Opening Remarks
Helene Langevin, MD, PhD; Richard Hodes, MD; Lesley Curtis, PhD

Introduction of the New Study Teams, NIH Program Staff, and Coordinating Center Core Work
Groups
Helene Langevin, MD, PhD; Richard Hodes, MD; Lesley Curtis, PhD

Overview of the NIH HCS Research Collaboratory Program
Cathy Meyers, MD

HEAL Initiative Overview
Rebecca Baker, PhD

Overview of a HEAL Cooperative Agreement
Wendy Weber, ND, PhD, MPH; Laura Wandner, PhD

Collaboratory Coordinating Center Overview and Goals
Adrian Hernandez, MD, MHS

CMS and the NIH Collaboratory
Joseph Chin, MD, MS

ClinicalTrials.gov Registration and Reporting
Stacey Arnold, PhD

Discussion From New UG3 NIH Collaboratory Trials

  • NOHARM
    Andrea Cheville, MD; Jon Tilburt, MD
  • FM TIPS
    Kathleen Sluka, PT, PhD; Leslie Crofford, MD
  • AcuOA
    Lynn DeBar, PhD, MPH; Karen J Sherman, PhD, MPH

Lessons Learned from Seasoned NIH Collaboratory Trials
Lesley Curtis, PhD; Ted Melnick, MD, MHS; Jerry Jarvik, MD, MPH; Vincent Mor, PhD; Doug Zatzick, MD; Miguel Vazquez, MD

Closing Remarks
Helene Langevin, MD, PhD; Richard Hodes, MD; Lesley Curtis, PhD

 

Wednesday, November 20, 2019

Welcome and Opening Remarks
Helene Langevin, MD, PhD; Richard Hodes, MD; Lesley Curtis, PhD

Breakout Sessions

Debrief for Breakout Sessions
Adrian Hernandez, MD, MHS; Patrick Heagerty, PhD; Leah Tuzzio, MPH; Rachel Richesson, PhD, MPH; Kevin Weinfurt, PhD; Lesley Curtis, PhD

Closing Remarks/Adjourn
Helene Langevin, MD, PhD; Richard Hodes, MD; Lesley Curtis, PhD

May 2019 Steering Committee Meeting

Steering Committee Meeting

May 1-2, 2019
Bethesda, MD

Main Purpose

Day 1: Discuss progress and sustainability of the NIH Collaboratory, hear perspectives on the landscape of embedded PCTs (ePCTs) and the need for real-world evidence, hear about challenges and lessons learned from the UH3 NIH Collaboratory Trials, get updates on progress and transition plans from the UG3 NIH Collaboratory Trials, discuss data sharing policy and planning, and conduct one-on-one consultations with representatives from the Core Working Groups.

Day 2: Intensive workshop to start discussions on statistical issues with ePCTs.

Wednesday, May 1, 2019

Welcome, Opening Remarks, and Introduction

David Shurtleff, PhD; Helene Langevin, MD; Richard Hodes, MD; Lesley Curtis, PhD

Keynote Panel

Perspectives on Generating Real-World Evidence and the Importance of Conducting ePCTs for Knowledge Dissemination and Implementation

Moderator: Catherine Meyers, MD

Landscape of ePCTs

Learn about the work of other ongoing pragmatic trial programs

Break/Core Representative Consultations

Core Leaders are available for one-on-one discussions to follow up on issues/topics from the NIH Collaboratory Trials

  • Biostatistics and Study Design Core: Liz Delong, PhD
  • Electronic Health Records Core: Rachel Richesson, PhD, MPH
  • Ethics and Regulatory Core: Judith Carrithers, JD, MPA
  • Health Care Systems Interactions Core: Eric Larson, MD, MPH
UH3 NIH Collaboratory Trials

Top barriers and challenges and recent generalizable lessons learned

Collaboratory's Review of Experiences with Manuscript Submissions

Devon Check, PhD

Data Sharing Plans

Adrian Hernandez, MD; Wendy Weber, ND, PhD, MPH

Lessons Learned From the Completed ePCTs

Experiences from the full lifecycle of an ePCT

Updates From the UG3 NIH Collaboratory Trials

Updates on lessons learned and challenges from Year 1, ongoing transition issues, and sustainability for the UH3 phase

Break/Core Representative Consultations
Review of Lessons Learned/Milestones From the Collaboratory and Sustainability of the Collaboratory*

Adrian Hernandez, MD

*Session topic deferred

Closing Remarks/Adjourn

David Shurtleff, PhD; Helene Langevin, MD; Richard Hodes, MD; Lesley Curtis, PhD

Thursday, May 2, 2019

Videocast of the Workshop on Design & Analysis of Embedded Pragmatic Clinical Trials
Workshop Summary on the Design and Analysis of Pragmatic Clinical Trials
Welcome and Introduction

Workshop Goals and Expectations

Helene Langevin, MD; Richard Hodes, MD; Catherine Meyers, MD; Wendy Weber, ND, PhD, MPH

Keynote

David Murray, PhD

Panel Discussions
Panel 1: Measurement and Data: Outcomes, Exposures, and Subgroups Based on EHR Data

Moderator: Rui Wang, PhD

  • Pragmatic Trial of Video Education in Nursing Homes (PROVEN): Vince Mor, PhD; Roee Gutman, PhD
  • STrategies to Reduce Injuries and Develop confidence in Elders (STRIDE): Nancy Latham, PhD, PT; Dave Ganz, MD, MPH; Peter Peduzzi, PhD
  • Active Bathing to Eliminate (ABATE) Infection: Susan Huang, MD, MPH; Ken Kleinman, ScD

Panel 2: To Cluster or Not to Cluster?

Moderator: Keith Goldfeld, DrPH

Pragmatic trials embedded in health care delivery systems must consider the organizational structure where individual patients are typically nested within providers, clinics, and higher level organizational units. Research design must consider trade-offs associated with elements of intervention delivery and analytical approaches that address the multi-level structure.

  • Improving Chronic Disease Management with Pieces (ICD-Pieces™): Miguel Vazquez, MD; Chul Ahn, PhD
  • Collaborative Care for Chronic Pain in Primary Care (PPACT): Lynn DeBar, PhD, MPH; William Vollmer, PhD
  • Suicide Prevention Outreach Trial (SPOT): Greg Simon, MD, MPH; Susan Shortreed, PhD

Panel 3: Choosing a Parallel Group or Stepped-Wedge Design

Moderator: Fan Li, PhD

Cluster-randomized trials are often limited in the number of clusters available for study, and therefore a variety of design alternatives are considered. One contemporary design is the stepped-wedge that leverages longitudinal follow-up of clusters and allows each cluster to be observed in both intervention and control states.

  • Lumbar Imaging with Reporting of Epidemiology (LIRE): Jerry Jarvik, MD, MPH; Patrick Heagerty, PhD
  • Pragmatic Trial of User-Centered Clinical Decision Support to Implement EMergency Department-Initiated BuprenorphinE for Opioid Use Disorder (EMBED): Ted Melnick, MD, MHS; Jim Dziura, MPH, PhD
  • A Policy-Relevant U.S. Trauma Care System Pragmatic Trial for PTSD and Comorbidity (Trauma Survivors Outcomes and Support [TSOS]): Doug Zatzick, MD; Patrick Heagerty, PhD

Panel 4: Unique Complications

Moderator: Andrea Cook, PhD

Embedded pragmatic clinical trials often encounter challenges that are associated with research embedded in a dynamic delivery system environment. Issues include questions about appropriate consent, strategies for monitoring trials for conduct quality and patient safety, and plans for handling unplanned changes in the research environment.

  • Pragmatic Trial of Higher vs. Lower Serum Phosphate Targets in Patients Undergoing Hemodialysis (HiLo): Myles Wolf, MD; Hrishikesh Chakraborty, DrPH
  • Strategies and Opportunities to Stop Colorectal Cancer in Priority Populations (STOP CRC): Bev Green, MD, MPH; William Vollmer, PhD
  • Time to Reduce Mortality in End-Stage Renal Disease (TiME): Laura Dember, MD; J. Richard Landis, PhD; Jesse Hsu, PhD
Summary and Concluding Remarks

Elizabeth Delong, PhD; Patrick Heagerty, PhD; Catherine Meyers, MD

May 2018 Steering Committee and Onboarding Meeting: Nudge, PRIM-ER, P4TH, EMBED, ACP PEACE, and HiLo

Steering Committee Meeting

May 14-16, 2018
Bethesda, MD

Main Purpose

Day 1: Welcome the new UG3 NIH Collaboratory Trials; provide introductions, an overview of the Collaboratory, and an understanding of the Core Working Groups; and discuss lessons learned, data sharing, and current ethics and regulatory issues.

Day 2: Celebrate the Collaboratory's progress; kick off the next 5 years; receive updates from the Core Working Groups; and hear about the top barriers/challenges and lessons learned from the UH3s.

Day 3: Intensive workshop to start discussions on embedded A vs. B pragmatic clinical trials.

Monday, May 14, 2018

Welcome, Opening Remarks, and Introductions
David Shurtleff, PhD; Richard Hodes, MD; Lesley Curtis, PhD

Overview of a Cooperative Agreement
Wendy Weber, ND, PhD, MPH

Overview of the NIH HCS Research Collaboratory Program
David Shurtleff, PhD

Panel of Directors: Richard Hodes, MD; Wilson Compton, MD; David Murray, PhD; Bill Riley, PhD; Gary Gibbons, MD; Rob Star, MD

Collaboratory Coordinating Center Overview and Goals
Adrian Hernandez, MD, MHS

Rethinking Clinical Trials: A Living Textbook of Pragmatic Clinical Trials
Jonathan McCall, MS

Policies and Guidance Documents

NIH Collaboratory Data Sharing Policy and Considerations
Adrian Hernandez, MD, MHS

Publications and Products Process
Eric Larson, MD, MPH

Data Quality
Rachel Richesson, PhD, MPH

New UG3 NIH Collaboratory Trials Updates
Brief overview of the projects

NIH and Other Requirements for ClinicalTrials.gov Reporting
Deborah Zarin, MD

Results Reporting of ePCTs
Adrian Hernandez, MD, MHS

Distributed Research Network Query Capabilities
Richard Platt, MD; Lesley Curtis, PhD

Closing Remarks
David Shurtleff, PhD; Richard Hodes, MD; Lesley Curtis, PhD 

Tuesday, May 15, 2018

Welcome and Opening Remarks
David Shurtleff, PhD; Richard Hodes, MD; Lesley Curtis, PhD

Landscape of National ePCT Initiatives
Explanation of initiatives that are promoting ePCTs and future directions

Health Systems Engagement Issues and Lessons Learned from the Health Care Systems Interactions Core
Eric Larson, MD, MPH

UH3 NIH Collaboratory Trials
Top barriers/challenges and recent generalizable lessons learned

 

Tuesday, May 15, 2018 (Continued)

Discussion From New UG3 NIH Collaboratory Trials
Overview of project and discussion

CMS Quality Measures
Reena Duseja, MD

Lessons Learned From Core Groups
Discussion on generalizable knowledge created out of the Cores, how it can be used, and future work of the Cores

Data Sharing Principles and Lessons Learned
Greg Simon, MD, MPH

Closing Remarks
David Shurtleff, PhD; Richard Hodes, MD; Lesley Curtis, PhD

Wednesday, May 16, 2018

Welcome and Introduction
David Shurtleff, PhD; Richard Hodes, MD; Catherine Meyers, MD; Wendy Weber, PhD, MPH

Panel Discussions

Panel 1: Partnering With Stakeholders to Conduct Embedded A vs. B Trials: Keys to Success Moderator: Rich Platt, MD, MSc

  • Steve Friedhoff, MD
  • Kenneth Sands, MD, MPH
  • Joseph Chin, MD

Panel 2: Examples in Action: Embedded A vs. B Trials Moderator: Beverly Green, MD, MPH

  • Ryan Ferguson, ScD, MPH
  • Susan Huang, MD, MPH
  • Michael Kappelman, MD, MPH

Panel 3: Maximizing the Pragmatic: Understanding Approaches to Design of Embedded A vs. B Trials Moderator: Greg Simon, MD, MPH

  • Scott Solomon, MD
  • Rachael Fleurence, PhD
  • Kourtney Davis, PhD, MSPH

Panel 4: Regulatory Aspects of Clinical Research and the Regulation of Products for Embedded A vs. B Pragmatic Trials Moderator: Adrian Hernandez 

  • Jacqueline Corrigan-Curay, MD, JD
  • Owen Faris, PhD
  • Julie Kaneshiro, MA

Panel 5: Ethical and IRB Approaches for a Successful Embedded A vs. B Pragmatic Trials Moderator: David Wendler, PhD

  • Barbara Bierer, MD
  • Spencer Hey, PhD
  • Judith Carrithers, JD, MPA

Summary Expert Panel Discussion Moderator: Cathy Meyers, MD

  • Adrian Hernandez, MD
  • Rich Platt, MD, MSc
  • Beverly Green, MD, MPH
  • Greg Simon, MD, MPH
  • Dave Wendler, PhD

Concluding Remarks 
Adrian Hernandez, MD, MHS; Rich Platt, MD, MSc

May 2017 Steering Committee Meeting

Steering Committee Meeting

May 23-24, 2017
Bethesda, MD

Main Purpose

Day 1: Celebrate the NIH Collaboratory's progress, receive updates from the Core Working Groups, hear about the top barriers, challenges, and lessons learned from the UH3 NIH Collaboratory Trials, and engage in an in-depth discussion of data sharing issues.

Day 2: An intensive workshop to broaden knowledge about dissemination, implementation, and sustainability of pragmatic clinical trial findings.

Tuesday, May 23, 2017

Welcome and Opening Remarks
Josephine Briggs, MD, Richard Hodes, MD, and Lesley Curtis, PhD

Keynote Speaker
Robert Califf, MD

NIH Collaboratory Trial Updates
Top Barriers/Challenges and Recent Generalizable Lessons Learned

Overview of the Revised Common Rule
Julie Kaneshiro, MA
Deputy Director, Office for Human Research Protections
Department of Health and Human Services

Potential Impact of the Revised Common Rule
Valery Gordon, PhD, MPH
Director, Clinical Research Policy Program
National Institutes of Health

NIH and Other Requirements for ClinicalTrials.gov Reporting
Deborah Zarin, MD
Director, ClinicalTrials.gov
National Institutes of Health

Vision of Data Sharing From the Collaboratory
Adrian Hernandez, MD, MHS

Data Governance/Data Sharing Panel Discussions
*Interactive panels - no slides presented

Panel 1: How Could Data From These Trials Inform Quality of Care, and What Are the Associated Considerations?
Moderator: Adrian Hernandez, MD, MHS

  • Miguel Vazquez, MD

  • Laura Dember, MD

  • Jerry Jarvik, MD, MPH

  • Susan Huang, MD

Panel 2: What Can NIH and Other Federal Bodies do to Incentivize and Support Data Sharing?
Moderator: Kevin Weinfurt, PhD

  • Doug Zatzick, MD

  • Greg Simon, MD, MPH

  • Bev Green, MD, MPH

Panel 3: What are Special Challenges and Strategies for Sharing Data Beyond Health Systems Data, Such As Medicare and Provider Data?
Moderator: Lesley Curtis, PhD

  • Vincent Mor, PhD

  • Gloria Coronado, PhD

  • Lynn DeBar, PhD, MPH

Panel 4: How Might These Projects Respond to Emerging Directions for Sharing Data and Tools?
Moderators: Wendy Weber, ND, PhD, MPH, and Lesley Curtis, PhD

  • Vincent Mor, PhD

  • Susan Huang, MD

  • Gloria Coronado, PhD

  • Jerry Jarvik, MD, MPH

  • Miguel Vazquez, MD

  • Greg Simon, MD, MPH

Living Textbook
Kevin Weinfurt, PhD

Closing Remarks
Josephine Briggs, MD, Richard Hodes, MD, and Lesley Curtis, PhD

Wednesday, May 24, 2017

Videocast of the Workshop on Pragmatic Clinical Trials - Unique Opportunities for Disseminating, Implementing, and Sustaining Evidence-Based Practices into Clinical Care 

Welcome and Opening Remarks
Josephine Briggs, MD, Richard Hodes, MD, Catherine Meyers, MD, and Wendy Weber, ND, PhD, MPH

Keynote Speaker
David Chambers, DPhil

  • Susan Huang, MD, MPH

  • Doug Zatzick, MD

  • Gloria Coronado, PhD

​Panel 2: Health System Engagement: Partnership, Relationships, and Transparency
Moderator: Eric Larson, MD, MPH

  • Miguel Vazquez, MD

  • John Warner, MD

  • Lynn DeBar, PhD, MPH

  • Andrew Bertagnolli, PhD

  • Vincent Mor, PhD

Panel 3: Swimming With the Sharks - Translation of Pragmatic Trial Results
*Interactive panel - no slides presented
Moderator: Lesley Curtis, PhD
Presenter: Greg Simon, MD, MPH
Responders:

  • Susan Mullaney, MHA

  • Edward Septimus, MD

  • Matt Hough, MD

Panel 4: Designing for Sustainability
Moderator: Amy Kilbourne, PhD, MPH

  • Laura Dember, MD

  • Jerry Jarvik, MD, MPH

  • Patrick Luetmer, MD

  • Greg Simon, MD, MPH

Panel 5: Stakeholder Reactions Panel Discussion
Moderator: Catherine Myers, MD

  • John Warner, MD

  • Susan Mullaney, MHA

  • Amy Kilbourne, PhD, MPH

Concluding Remarks
David Chambers, DPhil, and Eric Larson, MD, MPH

August 2014 Steering Committee and Onboarding Meeting: MCC Trials

Steering Committee Meeting

August 19-20, 2014
Bethesda, MD

Standing left to right: Bev Green, Sarah Duffy, Ed Septimus, Lynn DeBar, Greg Simon, Jerry Jarvik, Clayton Huntley, Laura Dember, Gila Neta, Partap Khalsa, Jerry Suls
Sitting left to right: Michael Lauer, Catherine Meyers, Josephine Briggs, Barry Coller, Rob Califf, Eric Larson, Wendy Weber, Rich Platt, Barbara Wells

Main Purpose

The purpose of this meeting is to welcome the new Multiple Chronic Condition UH2 NIH Collaboratory Trials, provide introductions, an overview of the Collaboratory, understanding of the Core Working Groups, discuss lessons learned, data sharing and current ethics and regulatory issues.

 

Tuesday, August 19, 2014

Welcome and Opening Remarks
Presenters: Barry Coller, MD, Josephine Briggs, MD, and Robert Califf, MD, MAAC
Opening Address 
Presenters: Thomas Insel, MD, and Michael Lauer, MD, FACC, FAHA (PDF)
Overview of the NIH HCS Research Collaboratory
Presenter: Josephine Briggs, MD

Presenter: Robert Califf, MD, MAAC

Introduction to the Core Working Groups
Discussion of MCC NIH Collaboratory Trials
Closing Remarks
Presenters: Barry Coller, MD, Josephine Briggs, MD, and Robert Califf, MD, MAAC

Reception and Dinner Presentations

Wednesday, August 20, 2014

Welcome and Opening Remarks
Presenters: Barry Coller, MD, Josephine Briggs, MD, and Robert Califf, MD, MAAC

Topic: Lessons Learned from:

Topic: Governance and Process

Overview of Ethics and Regulatory Issues (PDF)
Presenters: Robert Califf, MD, MAAC, and Jeremy Sugarman, MD, MPH, MA
CC Bioethics Supplement Update (PDF)
Presenters: Jeremy Sugarman, MD, MPH, MA, and Kevin Weinfurt, PhD

Panel of Directors

  • Josephine Briggs, MD (Chair) (PDF)
  • Richard Hodes, MD
  • Thomas Insel, MD
  • Judith Fradkin, MD
  • Patricia Grady, PhD
Closing Remarks
Presenters: Barry Coller, MD, Josephine Briggs, MD, and Robert Califf, MD, MAAC
Attendees

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February 2014 Steering Committee Meeting

Steering Committee Meeting

February 24-25, 2014
Bethesda, MD

Standing left to right: Bev Green, Sarah Duffy, Ed Septimus, Lynn DeBar, Greg Simon, Jerry Jarvik, Clayton Huntley, Laura Dember, Gila Neta, Partap Khalsa, Jerry Suls
Sitting left to right: Michael Lauer, Catherine Meyers, Josephine Briggs, Barry Coller, Rob Califf, Eric Larson, Wendy Weber, Rich Platt, Barbara Wells

Main Purpose

The purpose of this meeting is to celebrate the progress that has been made over the first year; discuss lessons learned; hear updates from the Cores, Working Groups, and Committees; and plan for the implementation phase of UH3s as well as the onboarding of the new UH2s.

Monday, February 24, 2014

Presenters: Josephine Briggs, MD, Robert Califf, MD, and Barry Coller, MD
Topic: Ethics Speaker
Presenter: Nancy Kass, ScD
Topic: NIH Work on Ethics
NIH Bioethics: Research to Inform Policy
Presenter: Kathy Hudson, PhD

Topic: Report on Ethics Supplements

Topic: Overview of Ethics and Regulatory Issues (Discussion Only)
Discussion led by: Robert Califf, MD, and Jeremy Sugarman, MD, MPH, MA
Topic: Distributed Research Network (DRN) Network Querying Capabilities/Investigator and NIH Initiative Use of the DRN
The NIH Collaboratory Distributed Research Network
Presenter: Richard Platt, MD, MSc

Topic: Data Governance/Data Sharing and the Distributed Research Network

Reception and Dinner Presentations

Tuesday, February 25, 2014

Welcome and Opening Remarks
Remarks by: Barry Coller, MD, Josephine Briggs, MD, and Robert Califf, MD

Topic: Lessons Learned from Cores/Working Groups

Topic: Lessons Learned from the NIH Collaboratory Trials (Discussion led by Eric Larson, MD, MPH)

Attendees

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