January 30, 2020: Meeting Materials from the NIH Collaboratory PRISM Kickoff Meeting

The Collaboratory has made available all the presentations from their recent PRISM Kickoff meeting held in Bethesda November 19-20, 2019.

PRISM Demonstration Project Investigators
Left to right: Kathleen Sluka, PT, PhD (FM TIPS); Andrea Cheville, MD (NOHARM); Karen Sherman, PhD, MPH (AcuOA); Jon Tilburt, MD (NOHARM); Lynn DeBar, PhD, MPH (AcuOA); Leslie Crofford, MD (FM TIPS); and Natalia Morone, MD (OPTIMUM).

The PRISM (Pragmatic and Implementation Studies for the Management of Pain to Reduce Opioid Prescribing) program is a component of the NIH HEAL Initiative to address the opioid crisis. Highlights of Day 1 included welcoming the 4 new PRISM UG3 Demonstration Projects—AcuOA, FM TIPS, NOHARM, and OPTIMUM—and introducing the study teams to the NIH Collaboratory Program and Coordinating Center, hearing an overview of the HEAL Initiative goals and cooperative agreement, and learning about the aims of the new studies. Day 2 included face-to-face meetings between each PRISM Demonstration Project and the Collaboratory Core working groups to discuss anticipated challenges in design, implementation, analysis, and dissemination.

View or download the meeting materials on the website.

 

 

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

 

January 16, 2020: NIH Collaboratory Investigators Describe Key Elements of Successful Distributed Research Networks

Members of the NIH Collaboratory Distributed Research Network (DRN) have helped build DRNs for the Sentinel System, the NIH Collaboratory, and the National Patient-Centered Clinical Research Network (PCORnet). In a new article published online in Contemporary Clinical Trials Communications, they describe the key elements of successful DRNs, as well as methods, challenges, and solutions encountered in using DRNs to support different phases of randomized, multisite clinical research.

“…[DRNs] are a vital component for trials that use real-world data to generate real-world evidence. Given their access to larger and more diverse populations, as well as health systems with a variety of care practices, DRN-based trials have the potential to produce more generalized results.” —Marsolo et al. 2020

DRNs enable the use of real-world data by repurposing electronic health record (EHR) and claims data for research. However, the use of these data to create evidence is “complicated by lack of uniformity in data collection, a fragmented healthcare system, and the imperative to protect research participants.”

The NIH Collaboratory DRN can support observational studies of comparative effectiveness and safety, prospective data collection, and randomized clinical trials. For more, see the list of publications and presentations.

January 15, 2020: NIH Collaboratory Announces Data and Resource Sharing Page

The NIH Collaboratory Coordinating Center has published a new Data and Resource Sharing Page on the Living Textbook, which is designed to share the data and resources generated by the Demonstration Projects.

“As part of the Collaboratory’s commitment to sharing, all NIH Collaboratory Demonstration Projects are expected to share data and resources, such as protocols, consent documents, public use datasets, computable phenotypes, and analytic code.”  —Data and Resource Sharing Page

The page holds links to datasets and data dictionaries, study tools, ethics and regulatory documentation, computable phenotypes and analytic code, data collection forms, study design papers, main outcomes papers, and other information that might be useful to others.

To assist clinical investigators in planning for sharing these resources, Demonstration Projects are given a Data and Resource Sharing Informational Document and an Onboarding Data and Resource Sharing Questionnaire during the onboarding process.

These documents contain:

  • Questions designed to help investigators think through the unique concerns when sharing data and resources from embedded pragmatic trials
  • Data sharing requirements for the NIH Collaboratory, NIH, and medical journals
  • Examples from NIH Collaboratory Demonstration Projects.
  • Descriptions of data sharing mechanisms, such as archives and enclaves
  • Examples of data sharing platforms
  • Examples of data sharing statements

At closeout, Demonstration Projects are provided a Closeout Data and Resource Sharing Checklist, and investigators from the completed projects use this checklist to provide a final data share package.

For more on data sharing, see the Living Textbook Chapter, Data Sharing and Embedded Research.

January 9, 2020: NIH Collaboratory Investigators Respond to Draft NIH Policy on Data Sharing

NIH Collaboratory leadership and Demonstration Project principal investigators, along with their colleagues, responded this week to the recently released Draft NIH Policy for Data Management and Sharing and supplemental draft guidance. The draft policy proposes that applicants for research funding submit a plan describing how scientific data will be managed and shared.

“We applaud the NIH’s policy and commitment to making the results and outputs of the research it funds and conducts available to the public. We enthusiastically support data sharing and agree with the principles of this policy. However, we believe more detail is warranted about the different types of research (ie, embedded pragmatic research), the associated protections, and acceptable mechanisms for sharing data, such as public and private archives and enclaves.” —Response to Draft NIH Policy for Data Management and Sharing

The main topics covered in the response are:

  • Support for the goals of the draft data sharing policy
  • Assessing and mitigating re-identification risk
  • Protecting secondary subjects
  • Use of data enclaves
  • Crediting those who share data

Other signatories include participants in the National Academy of Medicine’s Clinical Effectiveness Research Innovation Collaborative of the Leadership Consortium for Value and Science-Driven Health Care, and leaders of the Health Care Systems Research Network.

The full letter is available for download and includes the list of signatories.

Comments are due no later than January 10, 2020, and may be submitted online.

For more on data sharing, see the Living Textbook chapter, Data Sharing and Embedded Research.

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.

December 18, 2019: NIH Collaboratory Shares New Findings and Fresh Insights in 2019

NIH Collaboratory researchers in 2019 continued to generate new knowledge and research methods in pragmatic clinical trials. Their work included insights from the Coordinating Center and Core Working Groups, large-scale analyses of data from the NIH Collaboratory Distributed Research Network, and results and innovative methodological approaches from the Demonstration Projects.

So far this year, the NIH Collaboratory has produced nearly 3 dozen articles in the peer-reviewed literature, including the primary results of the ABATE Infection trial, confirmation by the TiME trial of the feasibility of embedding large pragmatic trials in clinical care, and more:

NIH Collaboratory Coordinating Center

NIH Collaboratory Distributed Research Network

ABATE Infection Demonstration Project

EMBED Demonstration Project

PPACT Demonstration Project

PRIM-ER Demonstration Project

PROVEN Demonstration Project

SPOT Demonstration Project

STOP CRC Demonstration Project

TiME Demonstration Project

TSOS Demonstration Project

November 1, 2019: Collaboratory PIs Give Advice to New Pragmatic Trials

The NIH Health Care Systems Research Collaboratory program is welcoming new embedded pragmatic clinical trials (ePCTs) on pain management and reducing opioid prescribing as part of the NIH’s Helping to End Addiction Long-term Initiative (NIH HEAL Initiative). At the same time, many of the Collaboratory’s early Demonstration Projects are completed and now publishing results. At a recent Collaboratory Steering Committee meeting, we spoke with four of the principal investigators (PIs) of completed trials to glean advice for new trials.

What words of advice do you have for investigators conducting their first embedded PCT?

Dr. Laura Dember, PI of the Time to Reduce Mortality in End-Stage Renal Disease (TiME) trial (NCT02019225).

Dr. Dember: “An important message is that progress in making big changes to how trials are conducted is going to be incremental. We need to be aspirational, but we also need to recognize that we’re not going to solve all of the problems with one try. We should not be discouraged by the things that don’t work, but rather keep moving forward by building on what we’ve learned.”

Dr. Lynn Debar, PI of the Collaborative Care for Chronic Pain in Primary Care (PPACT) trial (NCT02113592).

Dr. DeBar: “Regarding stakeholder engagement, recognize that these are really complex adaptive systems, and sometimes, more resources and harder pushing is not the way to accomplish your goal. You have to really think through how to communicate: where and how you push requires thinking about all the stakeholders involved.”

Dr. Beverly Green, Co-PI of the Strategies and Opportunities to Stop Colorectal Cancer (STOP CRC) trial (NCT01742065).

Dr. Green: “The collaboration part of bringing the investigators together to figure out the pieces of the puzzle has really been valuable to me. Really try to understand stakeholder engagement, the values of the people involved, and work to align them. This way, when you get it right, embedded pragmatic research can save money, improve health, and be a better experience for staff and patients. It’s a win-win.”

Dr. Susan Huang, PI of the Active Bathing to Eliminate (ABATE) Infection trial (NCT02063867).

Dr. Huang: “Communication is so important because if you have stakeholders at the table, not all of them will have the exact vantage point as you, and you will learn by communicating. And, if you’re learning different things and reaching different forks in the road that require decision-making and troubleshooting, it’s only by talking about them that you get everybody to really understand what the goal is. And in this way, you come up with better solutions than you could come up with yourself.”

What was the biggest lesson learned in conducting your trial?

Dr. Dember:  “It’s important to effectively engage with people on the ground. The extent to which this is possible depends on the setting, but, at least for some interventions, being able to engage with the people who are actually implementing the trial procedures is critical.”

Dr. Huang: “The biggest lesson is the critical nature of the partnership and the investment involved in maintaining it. The strength of our trial, and our ability to conduct it, was dependent on a strong partnership.”

Dr. Debar: “Vertical integration is important: you need high level buy-in, but you also need buy-in from people on the ground who are providing care.”

Dr. Green: “Someone in NIH did the math regarding how much an implementation study costs per participant, and he said, ‘That has to be cheaper.’ This prompted me to think about what things could be answered with embedded research. As a clinician, day to day, I am always making decisions that I don’t really know the answer because there isn’t enough evidence. There are so many questions that need to be answered, and embedded pragmatic research is a great starting point for getting more answers. We’ll never get there by doing this one trial at a time with traditional research.”

Congratulations to all four investigators for their groundbreaking work on their Demonstration Projects!

October 15, 2019: Postdoctoral Fellowship in the Ethics and Regulatory Aspects of Pragmatic Clinical Trials at Johns Hopkins

The Johns Hopkins Berman Institute of Bioethics invites applications for a Postdoctoral Fellowship in the Ethics and Regulatory Aspects of Pragmatic Clinical Trials. This position includes pursuing independent research, working alongside faculty members involved with the ethics and regulatory aspects of large-scale pragmatic clinical trials (PCTs), and participating in the Hecht-Levi Postdoctoral Fellowship in Bioethics. The postdoctoral fellow is expected to pursue one or more projects addressing the ethics and regulatory aspects of PCTs in collaboration with Berman Institute faculty members. The Fellow will actively engage with the Ethics and Regulatory Core of the NIH Health Care Systems Research Collaboratory and the Pragmatic and Implementation Studies for the Management of Pain to Reduce Opioid Prescribing (PRISM) Resource Coordinating Center.

Qualifications: Applications are welcome from candidates who will have an MD, PhD, or JD or their equivalent by the start date of the fellowship. Applicants should not have completed their terminal degree more than 3 years before the start date of the appointment. Physicians should not have completed a formal residency training program more than 3 years by the start date of the appointment.

Start date: September 1, 2020.

Terms of Appointment: The fellowship is guaranteed for 1 year with the expectation of a second year of funding, contingent on review. Applicants may not be employed by another institution and are expected to be in residence for the duration of the appointment.

How to apply: For details on how to apply see: https://bioethics.jhu.edu/education-training/fellowships/#fellowship-pragmatic. Applications must be submitted by December 16, 2019.

September 27, 2019: NIH Collaboratory to Serve as Coordinating Center for New Pragmatic Trials Addressing Opioid Crisis

The NIH Health Care Systems Research Collaboratory program is excited to announce that it has received funding to serve as the Resource Coordinating Center for a new group of large-scale embedded pragmatic clinical trials (ePCTs) on pain management and reducing opioid prescribing. As part of the NIH Collaboratory, the Pragmatic and Implementation Studies for the Management of Pain to Reduce Opioid Prescribing (PRISM) Resource Coordinating Center will provide technical support and pragmatic trial expertise for the research that this program funds. PRISM trials will determine the effectiveness of multiple non-opioid interventions for treating pain and assess the impact of implementing interventions or guidelines to improve pain management and reduce reliance on opioids.

The PRISM Resource Coordinating Center funding and new research awards, described below, are part of the NIH’s Helping to End Addiction Long-term Initiative (NIH HEAL Initiative). This federal research initiative, launched in early 2018 by NIH Director Francis S. Collins, aims to apply scientific solutions to improve treatments for chronic pain, curb the rates of opioid use disorder and overdose, and achieve long-term recovery for opioid addiction.

“The NIH Collaboratory Coordinating Center is excited to be supporting these novel pragmatic trials that address an urgent health crisis. We hope the patients, clinicians, researchers, and health systems will benefit from knowledge we’ve gained supporting complex trials embedded in health care systems over the past 7 years, which will help deliver improvements in pain management to the American public faster.” – Adrian Hernandez, MD, MHS, Vice Dean for Clinical Research, Duke University School of Medicine.

The PRISM awards total approximately $35.7 million and are supported by 8 participating NIH institutes, centers, and offices. With these awards, the NIH Collaboratory will add 4 new large-scale ePCTs to its portfolio of innovative Demonstration Projects. The trials will be conducted at Boston Medical Center, Massachusetts; Kaiser Foundation Research Institute, California; Mayo Clinic, Minnesota; and University of Iowa. They include:

  • Non-pharmacological Options in postoperative Hospital-based And Rehabilitation pain Management (NOHARM) pragmatic clinical trial
  • Fibromyalgia TENS in Physical Therapy Study (TIPS): An embedded pragmatic clinical trial
  • Group-based mindfulness for patients with chronic low back pain in the primary care setting
  • Pragmatic Trial of Acupuncture for Chronic Low Back Pain in Older Adults

The NIH Collaboratory aims to improve the way clinical trials are conducted by creating a new infrastructure for collaborative research with healthcare systems. The Collaboratory has 5 Core Working Groups of experts that help research teams address challenges of conducting research embedded in clinical care, and they collect and disseminate knowledge and best practices learned throughout the process. The ultimate goal is to ensure that healthcare providers and patients can make decisions based on the best available clinical evidence.

Related links:

NIH press release

Duke press release

NIH HEAL Initiative website

The Coordinating Center of the National Institutes of Health (NIH) Health Care Systems Research Collaboratory is supported by the NIH Common Fund through a cooperative agreement from the Office of Strategic Coordination within the Office of the NIH Director. Read more about the Collaboratory’s Demonstration Projects and the Core Working Groups.