January 24, 2020: Special Grand Rounds Series Begins January 31st With ‘Pragmatic Clinical Trials: How Do I Start?’

Join us Friday, January 31st, for “Pragmatic Clinical Trials: How Do I Start?”—the first in our special 5-part Grand Rounds series focused on the Living Textbook. NIH Collaboratory investigators Dr. Greg Simon and Dr. Lesley Curtis will offer guidance on what researchers need to begin an embedded pragmatic clinical trial, including:

  • Developing your research question
  • Establishing close partnerships with participating healthcare system leaders and staff
  • Putting together your trial team

Visit our events calendar here for details about how to join this webinar. See below for the full schedule of sessions and a special message from Dr. Kevin Weinfurt.

Full Schedule of sessions

Title Speakers Date
Pragmatic Clinical Trials:
How Do I Start?
Greg Simon, MD, MPH, KPWHRI

Lesley Curtis, PhD, Duke University

January 31, 2020
Preparing for the Unknown: Conducting Pragmatic Research in Real-World Contexts Jerry Jarvik, MD, MPH, University of Washington

Vince Mor, PhD, Brown University

Leah Tuzzio, MPH, KPWHRI

February 28, 2020
Tips for Putting Together a Successful PCT Grant Application Wendy Weber, ND, PhD, MPH, NCCIH March 27, 2020
Choosing What to Measure
and Making It Happen: Your Keys to Pragmatic Trial Success
Rachel Richesson, PhD, MPH, Duke University

Emily O’Brien, PhD, FAHA, Duke University

May 1, 2020
Demystifying Biostatistical Concepts for Embedded Pragmatic Clinical Trials Liz Turner, PhD, Duke University

Patrick Heagerty, PhD, University of Washington

David Murray, PhD, NIH

June 19, 2020

 

December 20, 2019: Embedded Pragmatic Clinical Trials: From Idea to Funding to Implementation: A Living Textbook Grand Rounds Series

Coming in 2020, the NIH Collaboratory will host a 5-part Grand Rounds Series focused on the Living Textbook. The series will feature Collaboratory expert speakers guiding the audience through the life cycle of an ePCT by way of the textbook—from idea to funding to implementation.

The series begins January 31 with “Pragmatic Clinical Trials: How Do I Start?” and will end June 19 with “Demystifying Biostatistical Concepts for Embedded Pragmatic Clinical Trials.”

See below for the full schedule of sessions and a special message from Dr. Kevin Weinfurt.

Full Schedule of sessions

Title Speakers Date
Pragmatic Clinical Trials:
How Do I Start?
Greg Simon, MD, MPH, KPWHRI

Lesley Curtis, PhD, Duke University

January 31, 2020
Preparing for the Unknown: Conducting Pragmatic Research in Real-World Contexts Jerry Jarvik, MD, MPH, University of Washington

Vince Mor, PhD, Brown University

Leah Tuzzio, MPH, KPWHRI

February 28, 2020
Tips for Putting Together a Successful PCT Grant Application Wendy Weber, ND, PhD, MPH, NCCIH March 27, 2020
Choosing What to Measure
and Making It Happen: Your Keys to Pragmatic Trial Success
Rachel Richesson, PhD, MPH, Duke University

Emily O’Brien, PhD, FAHA, Duke University

May 1, 2020
Demystifying Biostatistical Concepts for Embedded Pragmatic Clinical Trials Liz Turner, PhD, Duke University

Patrick Heagerty, PhD, University of Washington

David Murray, PhD, NIH

June 19, 2020

 

We hope you will join us to learn more about the fundamentals for designing and launching a successful ePCT. Please download the flyer for the Living Textbook Grand Rounds series and share with your colleagues and institution.

IMPACT Collaboratory: Are You Ready for a Pragmatic Trial? The RAPT Model and Implementation Considerations

Speakers:

Rosa Baier, MPH
Associate Director, Center for Long-Term Care Quality & Innovation
Associate Professor, Health Sciences, Policy & Practice
Brown University School of Medicine

Eric Jutkowitz, PhD
Assistant Professor
Brown University School of Public Health

Laura Gitlin, PhD, FGSA, FAAN
Dean, Distinguished Professor, Drexel University
Adjunt Professor, Johns Hopkins University

Read more about the RAPT Model.

Zoom Conferencing

Join from PC, Mac, iOS or Android: https://hebrewseniorlife.zoom.us/j/5479652617 

Dial-In: +1 646 876 9923 (US Toll) or +1 669 900 6833 (US Toll)

Meeting ID:  547 965 2617

January 11, 2019: FDA Releases Framework for Evaluating the Use of Real-World Evidence

To help fulfill the requirements of the 21st Century Cures Act by accelerating medical product development and fostering innovation and advances in medicine, FDA recently created a framework for evaluating the use of real-world evidence. The framework is intended to help evaluate trials that use real-world data for the creation of real-world evidence.

  • Real-world data: routinely collected information about a person’s health status in the electronic health record, claims, registries, and other sources, including patient-generated sources.
  • Real-world evidence: reliable, clinical information derived from real-world data about risks, benefits, and burdens of therapies.

This framework will apply to various pragmatic clinical trials embedded in health care systems and conducted as part of routine care (and will not apply to more traditional clinical trials conducted parallel to care).

Three main considerations are included in the framework:

  1. Will the real-world data be fit for use (do they reliably and adequately represent the concept)?
  2. Will the evidence generated by the trial provide adequate evidence to help answer regulatory questions?
  3. Will the conduct of the study meet FDA regulatory requirements?

December 11, 2018: Two New NIH Funding Opportunity Announcements for Pragmatic Trials Address the Opioid Crisis

The NIH has announced two new funding opportunity announcements (FOAs) for 7 or more embedded pragmatic clinical trials that address pain management and the opioid crisis. These projects will become part of the NIH Health Care Systems Research Collaboratory as phased UG3/UH3 cooperative research.

The two announcements are:

The announcements are part of the NIH Heal (Helping to End Addiction Long-term) Initiative, which was created in April 2018 in an effort to speed scientific solutions for addressing the national opioid public health crisis.

November 13, 2018: Summary of Workshop on Pragmatic Trials of Therapeutic A vs B Interventions Now Available

The NIH Collaboratory recently convened a workshop to explore embedded pragmatic clinical trials comparing two or more therapeutic medical interventions. These “A vs B” trials are meant to test existing, viable treatment alternatives where there is uncertainty about which treatment is best in which populations. There are unique barriers that make these types of pragmatic trials especially challenging to implement. For the workshop, a panel of experts gathered to discuss challenges and solutions regarding partnering with healthcare systems to conduct the trials, unique legal and ethical issues, and design and operational considerations. The summary of the workshop is now available: Workshop Summary: Embedded Pragmatic Clinical Trials of Therapeutic A vs. B Interventions

 

Additional Resources:

Embedded pragmatic clinical trials of therapeutic A vs. B interventions workshop videocast.

 

February 7, 2018: In New Video, Drs. Susan Huang and Gloria Coronado Give Advice to Pragmatic Trial Investigators

In the spring of 2018, the NIH Collaboratory will be welcoming a new set of Demonstration Projects and will help shepherd the new pragmatic trials through the piloting and implementation phases of their studies. In a new video in the Living Textbook, two of our seasoned principal investigators—Drs. Susan Huang and Gloria Coronado—give advice to the newcomers and other investigators new to conducting pragmatic trials.

Advice to New Pragmatic Trial Investigators from NIH Research Collaboratory on Vimeo.

“My greatest advice is to gain partners who are operational and have insight into particular areas—whether they be hospitals, or clinics, or nursing homes—who know about how they really work, how to best incorporate the intervention into workflow, how to get the right approvals, and how to get the best information technology support available to them.”—Susan Huang, MD

“One of the key things that we’ve received from being part of the Collaboratory—compared to an R01 grant—is the opportunity to interact across all of the institutes at NIH as well as learn about other projects that are working in pretty diverse health systems, including hospital systems, nursing homes, and dialysis centers.” —Gloria Coronado, PhD

October 11, 2017: New grant awarded to Dr. Jeffrey Jarvik and his team of investigators to promote pragmatic musculoskeletal clinical research

Congratulations to Dr. Jeffrey Jarvik and his colleagues at the University of Washington for their recent grant award to establish the Core Center for Clinical Research (CCCR). The initiative will promote pragmatic, multi-institutional clinical research on musculoskeletal conditions, such as the diagnosis and treatment of back pain. The new center—the UW Center for Clinical Learning, Effectiveness And Research (CLEAR)—will investigate the effectiveness of interventions such as imagining tests, physical therapy, opioids, spine injections, and spine surgery, as well as approaches for implementation.  The National Institutes of Health (NIH)/National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) are funding the 5-year, $3.7 million initiative, which will include pragmatic and comparative effectiveness trials and Core groups, including:

  • The Methodology Core, led by Patrick J. Heagerty PhD, Chair of the Department of Biostatistics, and Sean Mooney PhD, Professor of Biomedical Informatics and Chief Research Information Officer
  • The Resource Core, led by Janna Friedly MD, Associate Professor of Rehabilitation Medicine, and Danielle Lavallee PharmD PhD, Research Associate Professor of Surgery

Dr. Jarvik is a Professor of Radiology at University of Washington and the Principal Investigator the Collaboratory Demonstration Project, the Lumbar Imaging with Reporting of Epidemiology (LIRE) trial.

 

October 3, 2017: New Collaboratory Article Explores Data Sharing and Embedded Research

In an article published in Annals of Internal Medicine, authors from the NIH Collaboratory describe concerns and solutions regarding data sharing and embedded research. Pragmatic research embedded in health systems uses data from the electronic health record and comes from a fundamentally different context than explanatory trials, which collect research-specific data. Data from embedded research have the potential to do harm if taken out of context or used for comparisons. Therefore, while the authors enthusiastically support data sharing, they also recognize that mandating data sharing may discourage health systems from volunteering to participate in embedded research.

“In an ideal world of transparency regarding healthcare processes and outcomes, health systems would have no expectation of or need for privacy regarding quality of health care delivery.  But the current world is not perfect, and unintentional disclosures from participation in embedded research could be far greater than that required for public quality measures. Health systems volunteering to participate in research to improve public health may not be willing to bear the additional risk of misuse of sensitive information.” — Simon et al. Ann Intern Med

The authors use examples from the NIH Collaboratory Demonstration Projects to illustrate potential solutions, and emphasize that data sharing plans for embedded research should be developed in partnership with health system leaders in ways that maximize the amount of data that can be shared while protecting patient privacy and healthcare system interests.

September 27, 2017: Charter Template for Data Monitoring Committees for Pragmatic Clinical Trials Now Available

Data monitoring committee templateThe NIH Collaboratory Regulatory/Ethics Core has published a charter template that can be used to help establish a data monitoring committee (DMC) and associated procedures appropriate for oversight of pragmatic clinical trials. DMCs play an important role in protecting the welfare of trial participants and ensuring the integrity of a trial so that it can yield useful results. A charter defines the primary responsibilities of a DMC, its membership, the purpose and timing of its meetings, and its procedures and statistical monitoring guidelines.

In addition to procedures and guidance for DMCs generally, this new charter template contains suggested practices specifically for DMCs for pragmatic clinical trials, such as the recommendation that at least one DMC member have prior experience in conducting and interpreting data from this type of trial.

The charter template can be downloaded and customized by organizations to set up DMCs for pragmatic clinical trials and clearly outline their operations. For more information on special considerations in data and safety monitoring for pragmatic clinical trials, please see the Data and Safety Monitoring Living Textbook chapter.