trial onboarding

October 29, 2025 Virtual Onboarding Meeting: CARNATION

NIH Pragmatic Trials Collaboratory Onboarding Meeting

October 29, 2025
Virtual

Purpose

Welcome and hear from our new NIH Collaboratory Trial; provide introductions and an overview of the NIH Pragmatic Trials Collaboratory; hear from the Core Working Groups; and engage in discussion.

Welcome and Opening Remarks
Lesley Curtis
Wendy Weber*

Overview of the NIH Pragmatic Trials Collaboratory
Lesley Curtis
Wendy Weber*

Working With the NIH Collaboratory Coordinating Center
Kevin Weinfurt

Get to Know the New UG3 NIH Collaboratory Trial 
Coordinated cARe paiN mAnagement Technology ImplementatiON (CARNATION)
Lynn DeBar
Rachel Gold
Nicole Cook

Introduction to the Core Working Groups

 

Closing Remarks
Kevin Weinfurt
Wendy Weber*

 

*Unable to attend the onboarding meeting due to the federal government shutdown.

October 28, 2025 Virtual Onboarding Meeting: EquiP PC

NIH Pragmatic Trials Collaboratory Onboarding Meeting

October 28, 2025
Virtual

Purpose

Welcome and hear from our new NIH Collaboratory Trial; provide introductions and an overview of the NIH Pragmatic Trials Collaboratory; hear from the Core Working Groups; and engage in discussion.

Welcome and Opening Remarks
Adrian Hernandez
Wendy Weber*

Overview of the NIH Pragmatic Trials Collaboratory
Adrian Hernandez
Wendy Weber*

Working With the NIH Collaboratory Coordinating Center
Adrian Hernandez

Get to Know the New UG3 NIH Collaboratory Trial 
Equitable Primary Care for Pain Care (EquiP PC)
Kari Stephens

Introduction to the Core Working Groups

 

Closing Remarks
Adrian Hernandez
Wendy Weber*

 

*Unable to attend the onboarding meeting due to the federal government shutdown.

May 2025 Annual Steering Committee Meeting

Posted on by Sophia Ramirez

May 28-29, 2025 | Bethesda, MD

Main Purpose

Day 1: Hear from the newest and sunsetting NIH Collaboratory Trials; share challenges and lessons learned to promote successful trial conduct; discuss considerations for future embedded pragmatic clinical trials (ePCTs) such as understanding decision-maker perspectives and improving implementation of ePCT findings.
Day 2: Hear from the newest and recently transitioned NIH Collaboratory Trials; have rich discussions on topics including methods for building community relationships, lessons on using data repositories, and meeting posttrial responsibilities.

Agenda and Slides

Day 1: Wednesday, May 28, 2025

Welcome and Opening Remarks

Wendy Weber, ND, PhD, MPH; Lesley Curtis, PhD

The Future of ePCTs: Views From the Field

Discuss the future of ePCTs including what issues need to be addressed; Understand the current priorities, major initiatives, and cross-cutting activities of related research networks; Explore how the NIH Collaboratory might collaborate and contribute

Moderator: Adrian Hernandez, MD, MHS

Panel:

  • Lora Reineck, MD, MS
  • Amy Patterson, MD
  • Susan Mitchell, MD, MPH
  • Vincent Mor, PhD
  • Greg Simon, MD, MPH

Expanding ePCTs in Primary Care: How Do We Get There?

Describe lessons from implementing pragmatic trials in the primary care setting; Explore challenges of conducting research in primary care; Identify successful methods and knowledge gaps for research embedded in primary care

Moderator: Wendy Weber, ND, PhD, MPH

Panel:

  • Julie Fritz, PhD, PT
  • Natalia Morone, MD, MS
  • Sebastian Tong, MD, MPH

Perspectives From Sunsetting NIH Collaboratory Trials on Next Steps for ePCTs

Share investigator thoughts on future directions for pragmatic research as their NIH Collaboratory Trials end; Discuss what the NIH Collaboratory can do to help support future trials and increase national capacity for ePCTs

Moderator: Christine Goertz, DC, PhD

Panel:

  • Stacy Sterling, DrPH, MSW
  • Shruti Gohil, MD, MPH
  • Andrea Cook, PhD

Networking and Ask the Experts

Engage in small group discussion around topics of interest; Consult with Core Chairs and colleagues on issues your trial is facing

Report-Out From Networking Sessions

Describe action items for ePCTs identified in the breakout groups; Share common challenges, best practices, or areas of potential collaboration from the networking session with the group

APA-SM Flash Talk

Describe lessons learned, challenges overcome, and ongoing issues

Jennifer Kawi, PhD, MSN, FNP-BC, CNE, FAAN; Jane Bolin, PhD, JD, RN; Hulin Wu, PhD, MS

Significance in ePCTs: P Values vs Decision-Maker Perspectives

Discuss how investigators are considering decision-maker perspectives in their trials; Share lessons that prompt rethinking of measures or design in future trials; Explore how to bring scientific rigor to outcomes that matter in the real world

Moderator: Gregory Simon, MD, MPH

Panel:

  • Richard Platt, MD
  • Corita Grudzen, MD, MSHS, FACEP
  • Liz Turner, PhD

Improving Implementation of Digital Tools Developed in ePCTs

Discuss the decision process for whether and how to integrate digital tools into the EHR (or not); Explore the human factors that affect intervention uptake, fidelity, and sustainability

Moderator: Steven George, PT, PhD, FAPTA

Guests:

  • Keith Marsolo, PhD
  • Michele Balas, PhD, RN, CCRN-K, FCCM, FAAN
  • Andrea Cheville, MD, MSCE
  • Mike Ho, MD, PhD

Lightning Round: NIH Collaboratory Trial Results

Describe results, surprises, lessons learned, and future plans

Shruti Gohil, MD, MPH; Corita Grudzen, MD, MSHS, FACEP; Mike Ho, MD, PhD; Angelo Volandes, MD, MPH; Hrishikesh Chakraborty, PhD

Closing Remarks

Wendy Weber, ND, PhD, MPH; Lesley Curtis, PhD

Day 2: Thursday, May 29, 2025

Opening Remarks

Wendy Weber, ND, PhD, MPH; Lesley Curtis, PhD

LungSMART Utah Flash Talk

Describe lessons learned, challenges overcome, and ongoing issues

David Wetter, PhD, MS; Guilherme Del Fiol, MD, PhD; Ken Kawamoto, MD, PhD

Emerging Issues from Recently Transitioned Trials

Discuss lessons learned and challenges encountered in NIH Collaboratory Trials; Hear advice from seasoned investigators

Moderator: Angelo Volandes, MD, MPH

Panel:

  • Stephanie Fitzpatrick, PhD
  • Elizabeth Wick, MD
  • Chenchen Wang, MD, MSc

Building Relationships With Communities in Pragmatic Research

Learn how community relationships have enriched NIH Collaboratory Trials; Discuss impediments to meaningful community engagement in pragmatic trials; Describe successful methods for building relationships with communities

Moderator: Cherise Harrington, PhD, MPH

Panel:

  • David Wetter, PhD, MS
  • Jennifer Kawi, PhD, MSN, FNP-BC, CNE, FAAN
  • Sebastian Tong, MD, MPH
  • Kathleen Sluka, PT, PhD

STEP-2 Flash Talk

Describe lessons learned, challenges overcome, and ongoing issues

Rachel Winer, PhD, MPH; Amanda Petrik, PhD; Jasmin Tiro, PhD

What We Owe XXX After a Trial

Share experiences of NIH Collaboratory Trials in meeting posttrial responsibilities; Explore lessons and areas of opportunity related to the sharing of research findings

Moderators: Pearl O'Rourke, MD; Jeremy Sugarman, MD, MPH, MA

Panel:

  • Stephanie Morain, PhD
  • Hayden Bosworth, PhD
  • Angelo Volandes, MD, MPH

How Do We Support Broad Implementation of ePCT Findings?

Identify challenges and opportunities for investigators in implementing findings across a wide variety of health systems and communities; Review methods to help ensure all populations have access to sustainable interventions that could benefit them

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

Panel:

  • Ardith Doorenbos, PhD, RN, FAAN
  • Julie Fritz, PhD, PT
  • Kevin McLaughlin, DPT

Demystifying Data Sharing

Describe the process NIH Collaboratory Trials used to select a data repository; Discuss challenges encountered when using repositories; Share tips to streamline depositing data

Moderator: Keith Marsolo, PhD

Panel:

  • Diana Burgess, PhD
  • Andrea Cheville, MD
  • Andrea Cook, PhD

Monitoring and Navigating Changes in Usual Care

Explore how NIH Collaboratory Trials are documenting and monitoring usual care; Describe considerations for interim data pulls and futility decisions; Discuss impacts of an evolving healthcare setting and shifts in ePCT approaches needed

Moderator: Emily O'Brien, PhD

Panel:

  • Rachel Winer, PhD, MPH
  • Christine Goertz, DC, PhD
  • Shruti Gohil, MD, MPH

Closing Remarks

Wendy Weber, ND, PhD, MPH; Lesley Curtis, PhD

NIH-Hosted Workshop: Digging into Dilemmas of Pragmatic Clinical Trials (November 2025)

This 2-day workshop held in November 2025 introduces concepts in considerations for research in healthcare systems across a variety of communities; platform trials as an emerging method; implications of pragmatic trials with null findings for future pragmatic research; and the role of pragmatic trials in comparative effectiveness research of artificial intelligence algorithms.

 

January 8, 2025 Virtual Onboarding Meeting: STEP-2

NIH Pragmatic Trials Collaboratory Onboarding Meeting

January 8, 2025
Virtual

Purpose

Welcome and hear from our new NIH Collaboratory Trial; provide introductions and an overview of the NIH Pragmatic Trials Collaboratory; hear from the Core Working Groups; and engage in discussion.

Welcome and Opening Remarks
Wendy Weber
Adrian Hernandez

Overview of the NIH Pragmatic Trials Collaboratory and a Cooperative Agreement
Wendy Weber

Working With the NIH Collaboratory Coordinating Center
Adrian Hernandez

Brief Introduction to the Core Working Groups

New UG3 NIH Collaboratory Trial Overview
Self-Testing for Cervical Cancer in Priority Populations (STEP-2)
Rachel Winer
Amanda Petrik
Jasmin Tiro

Open Discussion
Adrian Hernandez

Closing Remarks
Wendy Weber
Adrian Hernandez

November 20, 2024 Virtual Onboarding Meeting: LungSMART

NIH Pragmatic Trials Collaboratory Onboarding Meeting

November 20, 2024
Virtual

Purpose

Welcome and hear from our new NIH Collaboratory Trial; provide introductions and an overview of the NIH Pragmatic Trials Collaboratory; hear from the Core Working Groups; and engage in discussion.

Welcome and Opening Remarks
Lesley Curtis
Beda Jean-Francois

Overview of the NIH Pragmatic Trials Collaboratory and a Cooperative Agreement
Beda Jean-Francois

Working With the NIH Collaboratory Coordinating Center
Lesley Curtis

Brief Introduction to the Core Working Groups

New UG3 NIH Collaboratory Trial Overview
Population Health Management Approaches to Increase Lung Cancer Screening in Community Health Centers (LungSMART)
David Wetter
Guilherme Del Fiol
Kensaku Kawamoto

Open Discussion
Lesley Curtis

Closing Remarks
Lesley Curtis
Beda Jean-Francois

October 24, 2024 Virtual Onboarding Meeting: APA-SM

NIH Pragmatic Trials Collaboratory Onboarding Meeting

October 24, 2024
Virtual

Purpose

Welcome and hear from our new NIH Collaboratory Trial; provide introductions and an overview of the NIH Pragmatic Trials Collaboratory; hear from the Core Working Groups; and engage in discussion.

Welcome and Opening Remarks
Wendy Weber, ND, PhD, MPH
Lesley Curtis, PhD

Overview of the NIH Pragmatic Trials Collaboratory and a Cooperative Agreement
Wendy Weber

Working With the NIH Collaboratory Coordinating Center
Lesley Curtis, PhD

Brief Introduction to the Core Working Groups

Prevention and Management of Chronic Pain in Rural Populations
Karen Kehl

New UG3 NIH Collaboratory Trial Overview
Jennifer Kawi
Hulin Wu
Jane Bolin

Open Discussion
Lesley Curtis

Closing Remarks
Wendy Weber
Lesley Curtis

May 2024 Annual Steering Committee Meeting

Posted on by Lauren Stewart

May 9-10, 2024 | Bethesda, MD

Main Purpose

Day 1: Hear from the newest NIH Collaboratory Trials; share challenges and lessons learned to promote successful trial conduct; discuss the evolution and current state of the NIH Collaboratory ecosystem; identify gaps and areas of opportunity for expanding the ecosystem of embedded pragmatic clinical trials (ePCTs).
Day 2: Have rich discussions on overcoming challenges in ePCTs, fostering patient engagement, and creating reusable infrastructure; share insights from seasoned NIH Collaboratory Trials on posttrial activities and moving to the next ePCT.

Fireside chat 3

Agenda and Slides

Day 1: Thursday, May 9, 2024

Welcome and Opening Remarks

Wendy Weber, ND, PhD, MPH; Lesley Curtis, PhD

Highlights of the NIH Pragmatic Trials Collaboratory

Feature major accomplishments of the program; review specific requirements for the new trials; offer guidance and answer questions

Wendy Weber, ND, PhD, MPH

Ethical and Regulatory Challenges/Lessons Learned

Hear from the NIH Collaboratory Trials about ethical and regulatory challenges encountered; Discuss strategies for navigating ethical and regulatory complexities of ePCTs

Moderator: Stephanie Morain, PhD

Panel:

  • Michele Balas, PhD, RN, CCRN-K, FCCM, FAAN
  • Diana Burgess, PhD
  • Richard Skolasky, ScD, MA

Study Design Challenges/Lessons Learned

Learn about study design issues faced by the NIH Collaboratory Trials; Share statistical and methodological considerations important for the planning phase and beyond

Moderator: Patrick Heagerty, PhD

Panel:

  • Sheana Bull, PhD, MPH

  • Stephanie Fitzpatrick, PhD
  • Chenchen Wang, MD, MSc

Data Access and Management Challenges/Lessons Learned

Hear from the NIH Collaboratory Trials about challenges with data access, planning for data management, and data sharing; Review methods for addressing issues related to data security, privacy, and approval for data use

Moderator: Rachel Richesson, PhD, MPH, MS, FACMI

Panel:

  • Richard Skolasky, ScD, MA

  • Ed Vasilevskis, MD, MPH

Lessons and Challenges Engaging Rural Populations

Share progress on ePCTs for the prevention and management of chronic pain in rural populations, describing challenges and lessons learned; Begin communication that may lead to joint publications on methods and strategies, and/or future collaborations

Moderators: Karen Kehl, PhD, RN, FPCN

Panel:

  • Julie Fritz, PhD, PT

  • Richard Skolasky, ScD, MA

  • Sebastian Tong, MD, MPH
  • Katie Hadlandsmyth, PhD

Welcome and Introduction of Fireside Chat

Welcome participants, introduce the Fireside Chat, and kick off the afternoon session for all NIH Collaboratory Trials

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

Fireside Chat: Pragmatic Research and National Health Priorities

Hear thoughts on how pragmatic research can help address the nation’s top health priorities; Discuss how to maximize evidence generation from ePCTs and achieve the greatest benefits for the U.S. population

Moderator: Wendy Weber, ND, PhD, MPH

Guests:

  • Monica Bertagnolli, MD
  • Robert Califf, MD

State of the NIH Pragmatic Trials Collaboratory Ecosystem

Share an overview of the characteristics of trials in the NIH Collaboratory, such as populations, partner types (e.g., hospitals, primary care, community clinics, FQHCs); Discuss the evolution of the program and identify gaps and areas of opportunity

Kevin Weinfurt, PhD

Addressing Barriers to ePCTs Involving Approved Drugs

Describe barriers to conducting ePCTs involving approved drugs, including trials with repurposed drugs and A vs B trials; Explore potential ways to overcome these barriers, including how the NIH Collaboratory might contribute

Moderator: Adrian Hernandez, MD, MHS

Panel:

  • Pearl O'Rourke, MD
  • Kevin Bugin, PhD
  • Leonard Sacks, MD
  • Tracy Wang, MD, MHS, MSc

Promoting Patient Engagement in ePCTs

Review the Coordinating Center’s efforts to support patient engagement; Hear from NIH Collaboratory Trials on challenges and methods for engaging patients in ePCTs

Moderator: Steven George, PT, PhD

Panel:

  • Natalia Morone, MD, MS
  • Chenchen Wang, MD, MSc

Fostering Development of Up-and-Coming ePCT Investigators

Hear flash talks from NIH Collaboratory fellows

Moderator: Emily O'Brien, PhD

Presenters:

  • Lindsay Ballangee, DPT
  • Kaitlyn McLeod, MD

Closing Remarks

Wendy Weber, ND, PhD, MPH; Lesley Curtis, PhD

Day 2: Friday, May 10, 2024

Opening Remarks

Wendy Weber, ND, PhD, MPH; Lesley Curtis, PhD

BackInAction Results

Hear preliminary main outcomes

*No slides for this presentation

Lynn DeBar, PhD

Clinician and Health System Engagement Challenges/Lessons Learned

Hear about challenges engaging clinicians and health systems; Discuss ways to strengthen these relationships to support ePCTs; Share how trials are planning for retraining of clinical staff when there is turnover

*No slides for this panel

Moderator: Greg Simon, MD, MPH

Panel:

  • Andrea Cheville, MD
  • Christine Goertz, DC, PhD
  • James Tulsky, MD

Data Extraction and Quality Challenges/Lessons Learned

Learn about issues encountered with EHR integration, data extraction, and data quality; Share ways to mitigate data-related challenges, such as cleaning as you go and strong investigator–analytic team collaborations

Moderator: Keith Marsolo, PhD

Panel:

  • Dana Dailey, PT, PhD
  • Shruti Gohil, MD, MPH
  • Corita Grudzen, MD, MSHS

Expanding the ePCT Ecosystem to Better Serve Minoritized Communities

Discuss the increasing burden on minoritized communities and health systems serving them; Review the makeup of NIH Collaboratory Trial sites (academic medical centers, community hospitals, etc.) and explore how to expand the types

Moderator: Cherise Harrington, PhD, MPH

Panel:

  • Eliseo J. Pérez-Stable, MD
  • Stephanie Fitzpatrick, PhD
  • Sebastian Tong, MD, MPH

Building and Sustaining Reusable Infrastructure for ePCTs

Describe reusable infrastructure being used to promote ePCTs outside the NIH Collaboratory; Explore different models for sustaining infrastructure for ePCTs

Moderator: Christine Goertz, DC, PhD

Panel:

  • Lynn DeBar, PhD
  • Julie Fritz, PhD, PT
  • Greg Simon, MD, MPH

Exploring the Generative Investment of an ePCT for Catalyzing Research

Discuss elements of research platforms in NIH Collaboratory Trials most at risk of dissipating and needing to be rebuilt for future research; Describe which elements could be reused (e.g., relationships, teams, interventions, EHR/IT systems)

Moderator: Greg Simon, MD, MPH

Panel:

  • Susan Huang, MD, MPH
  • Natalia Morone, MD, MS
  • Jon Tilburt, MD

Planning Effectively for Posttrial Activities

Discuss preparing for dissemination and sustainment or de-implementation before results are known; describe considerations for when and how to share results with partners and the public; Learn ways to share trial tools more widely, and explore Dissemination and Implementation R01s

Moderator: Hayden Bosworth, PhD

Panel:

  • Shruti Gohil, MD, MPH
  • Corita Grudzen, MD, MSHS
  • Stacy Sterling, DrPH, MSW

How to Transition to the Next Research Opportunity

Share insights from NIH Collaboratory Trials that informed subsequent pragmatic trials; Learn which aspects investigators preserved in subsequent trials, and which aspects they discontinued or added

Moderator: Rich Platt, MD, MSc

Panel:

  • Lynn DeBar, PhD
  • Mike Ho, MD, PhD
  • Angelo Volandes, MD, MPH

Closing Remarks

Wendy Weber, ND, PhD, MPH; Lesley Curtis, PhD

NIH-Hosted Workshop: Going From Zero to 100: Generating Evidence Through Pragmatic Research to Address Pressing Healthcare Issues (July 2024)

This 2-day workshop held during July 2024 explores the preparatory actions researchers can take in the planning and application phase (Phase Zero) to ensure pragmatic clinical trials yield actionable evidence for various settings.

 

November 1, 2023 Virtual Onboarding Meeting: iPATH, AIM-CP, I CAN DO Surgical ACP, MOMS, RAMP, and ARBOR-Telehealth

NIH Pragmatic Trials Collaboratory Onboarding Meeting

November 1, 2023
Virtual

Purpose

Welcome the new UG3 and R01 NIH Collaboratory Trials; provide introductions and an overview of the NIH Collaboratory program; hear from the new UG3 and R01 project teams; and discuss lessons learned from the seasoned NIH Collaboratory Trial investigators.

Welcome and Opening Remarks
Wendy Weber, ND, PhD, MPH
Lesley Curtis, PhD

Overview of the NIH Pragmatic Trials Collaboratory and a Cooperative Agreement
Beda Jean-Francois, PhD

NIH Collaboratory Coordinating Center: Overview and Goals
Lesley Curtis, PhD

Program Policies and Guidance Documents
Rich Platt, MD, MSc
Gina Uhlenbrauck

Discussion of New NIH Collaboratory Trials

  • iPATH
    Sara Singer, PhD, MBA
  • AIM-CP
    Sebastian Tong, MD, MPH
    Kushang Patel, Phd, MPH
  • MOMs
    Stephanie Fitzpatrick, PhD
  • RAMP
    Diana Burgess, PhD
    Roni Evans, DC, MS, PhD
    Katherine Hadlandsmyth, PhD

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

Panel:

  • Lynn Debar, PhD
  • Angelo Volandes, MD, MPH
  • Susan Huang, MD, MPH
  • Michael Ho, MD, PhD
  • Kathleen Sluka, PT, PhD
  • Andrea Cheville, MD

Closing Remarks
Beda Jean-Francois, PhD
Lesley Curtis, PhD

July 17, 2023 Virtual Onboarding Meeting: BEST-ICU, LE8 Bot + Backup, and TAICHIKNEE

NIH Pragmatic Trials Collaboratory Onboarding Meeting

July 17, 2023
Virtual

Purpose

Welcome the new UG3 NIH Collaboratory Trials; provide introductions and an overview of the NIH Collaboratory program; hear from the new UG3 project teams; and discuss lessons learned from the seasoned NIH Collaboratory Trials investigators.

Welcome and Opening Remarks
Wendy Weber, ND, PhD, MPH
Lesley Curtis, PhD

Overview of the NIH Pragmatic Trials Collaboratory and a Cooperative Agreement
Wendy Weber, ND, PhD, MPH

NIH Collaboratory Coordinating Center: Overview and Goals
Adrian Hernandez, PhD

Program Policies and Guidance Documents
Adrian Hernandez, MD, MHS
Damon Seils, MA

Discussion of New UG3 NIH Collaboratory Trials

  • BEST-ICU
    Michele Balas, PhD, RN, CCRN-K, FCCM, FAAN
    Eduard Vasilevskis, MD, MPH
  • TAICHIKNEE
    Chenchen Wang, MD, MSc
    Eric Roseen, DC, MSc
    Robert Saper, MD
    Helen Lavertsky, MD, MS

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

Panel:

  • Miguel Vazquez, MD (ICD-Pieces)
  • Sheana Bull, PhD, MPH (Nudge)
  • Angelo Volandes, MD, MPH (ACP PEACE)
  • Stacy Sterling, DrPH, MSW (GGC4H)
  • Lynn DeBar, PhD (PPACT, BackInAction)
  • Julie Fritz, PhD, PT (BeatPain Utah)

Closing Remarks
Wendy Weber, ND, PhD, MPH
Lesley Curtis, PhD

May 2023 Steering Committee Meeting

Image

Steering Committee Meeting

May 16-17, 2023

Bethesda, MD

Kevin Weinfurt 3

Main Purpose

To discuss important considerations for Collaboratory trials and the embedded pragmatic clinical trial ecosystem at large, including implementation science in the context of pragmatic trials, data sharing models and experiences, barriers encountered, and lessons learned.

Tuesday, May 16, 2023

Welcome and Opening Remarks

Helene Langevin, MD, PhD; Lesley Curtis, PhD

Keynote Panel: Implementation Science

Discuss the role of implementation science in ePCTs. 

David Chambers, DPhil

Focus on Implementation Science: Insights From Trials

Hear from the NIH Collaboratory Trials about intervention implementation/delivery challenges. Discuss pitfalls and barriers in the delivery of the intervention. Understand how the Implementation Science Core can help mitigate some of the challenges and facilitate next steps.

Moderator: Devon Check, PhD

Panel:

Focus on Implementation Science: Intervention Delivery Complexity and the Collaboratory Tool

Introduce the intervention complexity tool. Understand how intervention complexity can impact the ability to get results. Identify what can be done differently to reduce complexity and the next steps in tool development. Hear from Projects (ACP COVID and PROVEN) that have used the tool and lessons learned.

Moderator: Steven George, PT, PhD

Speaker: Lindsay Ballengee

Panel:

  • Angelo Volandes, MD, MPH
  • Vince Mor, PhD

Cross-Core Collaborations

Learn about the cross-Core collaborations among the Ethics and Regulatory, Electronic Health Records, Biostatistics and Study Design, Patient-Centered Outcomes, Health Care Systems Interactions, Implementation Science, and Health Equity Cores.

Moderator: Kevin Weinfurt, PhD

Panel:

  • Rosa Gonzalez-Guarda, PhD, MPH, RN, CPH, FAAN
  • Keith Marsolo, PhD
  • Emily O'Brien, PhD, FAHA
  • Greg Simon, MD, MPH
  • Jeremy Sugarman, MD, MPH, MA

Keynote: Focus on Health Equity

Discuss national priorities for improving health equity. Describe principles and opportunities for integrating a health equity lens throughout the research life cycle.

Eliseo J. Pérez-Stable

Panel Discussion

Discuss experiences bringing a health equity lens into ePCTS.

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

Panel:

Focus on Health Equity: The ePCT Landscape/Ecosystem

Identify what national programs and initiatives are doing to improve health equity. Discuss best practices for engaging minoritized and other underrepresented communities to improve health equity. Examine the impact of these initiatives and how lessons are disseminated across different stakeholder groups.

Moderator: Cherise Harrington, PhD, MPH

Panel:

Discussion from New NIH Collaboratory Trial (INSPIRE)

Hear update on lessons learned from Year 1, ongoing transition issues, sustainability for the UH3 phase, any challenges, and discussion of data sharing plans.  

Shruti Gohil, MD, MPH; Rich Platt, MD, MSc

Top Barriers/Challenges and Recent Generalizable Lessons Learned From the UH3s

NIH Collaboratory Trials discuss barriers, challenges, and lessons learned. 

Closing Remarks

Wendy Weber, ND, PhD, MPH; Lesley Curtis, PhD

Wednesday, May 17, 2023

Welcome and Opening Remarks

Lesley Curtis, PhD; Wendy Weber, ND, PhD, MPH

Clinical Decision Support Software in ePCTs - FDA and Regulatory Perspectives

Describe case studies from the Collaboratory and beyond illustrating challenges with clinical decision support software.

Adrian Hernandez, MD, MHS

Hear from the FDA about the newly released guidance on clinical decision support software and the associated considerations and opportunities for ePCTs.

Matt Diamond; Sonja Fulmer

Hear about regulatory, ethical, and IRB considerations related to evaluation of clinical decision support tools.

Pearl O'Rourke, MD; Jeremy Sugarman, MD, MPH, MA

Hear about considerations related to evaluation of clinical decision support tools from the perspective of ePCT trialists.

Moderator: Greg Simon, MD, MPH

NIH and Other Requirements for ClinicalTrials.gov Reporting

Learn about requirements for registering and reporting the results of clinical trials to ClinicalTrials.gov. Hear about efforts to modernize the ClinicalTrials.gov and Protocol Registration and Results System (PRS) databases. Review PRS options for data entry for ePCTs and discuss ways to address issues that arise in reporting.

Speaker: Stacey Arnold

What's New With Data Sharing and Repositories

Hear from the NIH about the new data sharing policy that was released in January 2023. Learn the changes and exceptions, noting that all new NIH Pragmatic Trials Collaboratory and all PRISM projects will be required to share data. Learn from the NIH various data sharing options and suggested criteria for identifying a data repository for your study.

Speaker: Taunton Paine

Clarifying Different Scientific Goals and Resources Needed for Data Sharing Based on Collaboratory Experiences

Discuss the different scientific goals that motivate data sharing. Discuss the resources needed to achieve each of the goals. Describe early Collaboratory experiences in the use of shared data.

Speaker: Keith Marsolo, PhD

Lightning Round - Sharing Results With Patients and Participants

Discuss approaches to sharing results with participants and community stakeholders.

Moderator: Kevin Weinfurt, PhD

Panel:

Lessons on Data Sharing From the HEAL Bioethics Supplement

Discuss ethical issues associated with data sharing, including lessons learned from the Bioethics Supplement.

Speaker: Stephanie Morain, PhD, MPH

How Do We Drive Change in the Incentive Structure to Promote Data Sharing?

Discuss incentives for data sharing including those for researchers, clinicians, and healthcare system leaders. Discuss how to improve patient understanding of the importance of data sharing and encourage participation.

Speaker: Adrian Hernandez, MD, MHS

Top Barriers/Challenges and Recent Generalizable Lessons Learned From the UH3s

NIH Collaboratory Trials discuss barriers, challenges, and lessons learned. 

Closing Remarks

Wendy Weber, ND, PhD, MPH; Lesley Curtis, PhD

NIH-Hosted Workshop: Getting the Right Evidence to Decision-Makers Faster (June 2023)

This 2-day workshop held during June 2023 explores the critical cycle of evidence generation to decision by health system leaders to implement the findings of pragmatic clinical trials (PCTs) conducted within health care systems.