DRN

December 15, 2025: A Year of Trial Results and Innovations From the NIH Pragmatic Trials Collaboratory

Posted on by Damon Seils

A collage of journal covers with the label "NIH Pragmatic Trials Collaboratory 2025 Publications Roundup"In 2025, NIH Pragmatic Trials Collaboratory investigators published new study designs and trial results, shared insights from program leadership, and developed innovative methods in the design, conduct, implementation, and dissemination of pragmatic clinical trials. Their work included perspectives from the Coordinating Center, best practices from the Core Working Groups, and results from the NIH Collaboratory Trials.

The program contributed 45 articles to the peer-reviewed literature this year, including the primary results of the ACP PEACE, BackInAction, HiLo, INSPIRE, and PRIM‑ER trials. Cross-Core and cross-Trial collaborations led to the sharing of important lessons from the conduct of multiple NIH Collaboratory Trials.

The total number of published articles from the program reached 386.

Coordinating Center

Cross-Core and Cross-Trial Collaborations

Distributed Research Network

Core Working Groups

Biostatistics and Study Design Core

Community Health Improvement Core

Electronic Health Records Core

Ethics and Regulatory Core

Health Care Systems Interactions Core

Patient-Centered Outcomes Core

NIH Collaboratory Trials

ABATE Infection

ACP PEACE

ARBOR-Telehealth

BackInAction

BeatPain Utah

BEST-ICU

EMBED

FM-TIPS

GGC4H

GRACE

HiLo

I CAN DO Surgical ACP

IMPACt-LBP

INSPIRE

iPATH

LIRE

MOMs Chat & Care Study

NOHARM

Nudge

OPTIMUM

PRIM-ER

SPOT

TAICHIKNEE

December 14, 2021: A Year of New Insights From the NIH Collaboratory

Posted on by Damon Seils

Collage of journal coversNIH Collaboratory researchers in 2021 shared study results, generated new knowledge, and developed innovative research methods in pragmatic clinical trials. Their work included insights from the Coordinating Center and Core Working Groups, analyses from the NIH Collaboratory Distributed Research Network, and results and methodological approaches from the NIH Collaboratory Trials.

So far this year, the NIH Collaboratory has produced 3 dozen articles in the peer-reviewed literature, including the primary results of the PPACT and TSOS trials, the study design of the Nudge and OPTIMUM studies, insights into the COVID-19 pandemic from the EMBED and ACP PEACE studies, and more:

NIH Collaboratory Coordinating Center

NIH Collaboratory Distributed Research Network

ACP PEACE NIH Collaboratory Trial

BackInAction NIH Collaboratory Trial

EMBED NIH Collaboratory Trial

GRACE NIH Collaboratory Trial

HiLo NIH Collaboratory Trial

LIRE NIH Collaboratory Trial

Nudge NIH Collaboratory Trial

OPTIMUM NIH Collaboratory Trial

PPACT NIH Collaboratory Trial

PRIM-ER NIH Collaboratory Trial

PROVEN NIH Collaboratory Trial

SPOT NIH Collaboratory Trial

TSOS NIH Collaboratory Trials

February 24, 2021: Study Using Distributed Research Network Finds Low Incidence of High-Priority Prescribing Cascades in Alzheimer Disease

Posted on by Damon Seils

The incidence of a specific type of “prescribing cascade” among patients with Alzheimer disease is low, according to a new analysis of data from the NIH Collaboratory Distributed Research Network (DRN). The study was published in the Journal of the American Geriatrics Society.

Persons with Alzheimer disease are at high risk for prescribing cascades, in which patients receive potentially unnecessary drug prescriptions to address side effects of their other medications. Although prescribing cascades involving antidopaminergic and antiparkinsonian medications in particular have been identified as a high-priority target for improving medication safety in patients with Alzheimer disease, little is known about their incidence in this population.

Investigators from the Controlling and Stopping Cascades Leading to Adverse Drug Effects Study in Alzheimer’s Disease (CASCADES‐AD) used administrative claims data from 2 large commercial health insurance providers to address this gap in knowledge. The providers are data partners in the NIH Collaboratory DRN. Using data for more than 121,000 patients with Alzheimer disease, the researchers found that the proportion of antidopaminergic-antiparkinsonian medication prescribing cascades was low. Only 36 patients received an antiparkinsonian medication out of more than 4500 patients who were taking an antipsychotic drug or metoclopramide.

CASCADES-AD was supported by a grant from the National Institute on Aging. Read more about the NIH Collaboratory DRN.

December 15, 2020: A Year of Results and New Insights From the NIH Collaboratory

Posted on by Damon Seils

Collection of Journal CoversNIH Collaboratory researchers in 2020 reported study results, generated new knowledge, and developed innovative research methods in pragmatic clinical trials. Their work included insights from the Coordinating Center and Core Working Groups, analyses from the NIH Collaboratory Distributed Research Network, and results and methodological approaches from the NIH Collaboratory Trials.

So far this year, the NIH Collaboratory has produced more than 3 dozen articles in the peer-reviewed literature, including the primary results of the PROVEN and LIRE trials, the study design of ACP PEACE, insights into the COVID-19 pandemic from TSOS and EMBED, and more:

NIH Collaboratory Coordinating Center

NIH Collaboratory Distributed Research Network

ACP PEACE NIH Collaboratory Trial

EMBED NIH Collaboratory Trial

HiLo NIH Collaboratory Trial

LIRE NIH Collaboratory Trial

PPACT NIH Collaboratory Trial

PRIM-ER NIH Collaboratory Trial

PROVEN NIH Collaboratory Trial

SPOT NIH Collaboratory Trial

STOP CRC NIH Collaboratory Trial

TSOS NIH Collaboratory Trial

July 21, 2020: Distributed Research Network Study Finds Lower Rates of Alzheimer Disease and Related Dementias in Medicare Advantage Plans

Posted on by Damon Seils

The prevalence of diagnosed Alzheimer disease and related dementias (ADRD) is lower in Medicare Advantage health insurance plans than in traditional fee-for-service Medicare, according to a new analysis of data from the NIH Collaboratory Distributed Research Network (DRN). The study was published this month in Alzheimer’s & Dementia.

NIH Collaboratory DRN HandoutMuch of the current understanding about the characteristics and experiences of people diagnosed with ADRD comes from studies of fee-for-service Medicare beneficiaries. These studies typically do not include the one-third of Medicare beneficiaries who are enrolled in Medicare Advantage plans.

In the new analysis, Jutkowitz and colleagues used data from 3 large health insurance providers that make up 30% of the Medicare Advantage health insurance market. The 3 providers are data partners in the NIH Collaboratory DRN. The researchers found that the age- and sex-stratified prevalence of ADRD among Medicare Advantage beneficiaries was lower than among fee-for-service beneficiaries. They also observed higher disenrollment rates among Medicare Advantage beneficiaries—up to 30% at 1 year—than were found in previous studies. The findings have methodological implications for research in both Medicare Advantage and fee-for-service Medicare populations.

This work was supported within the NIH Collaboratory by the NIH Common Fund through a cooperative agreement from the Office of Strategic Coordination within the Office of the NIH Director and through the NIA IMPACT Collaboratory by the National Institute on Aging. Supplemental funding was provided by the National Center for Complementary and Integrative Health. Learn more about the NIH Collaboratory DRN.

February 7, 2020: NIH Collaboratory Distributed Research Network Solicits Data Queries to Advance Collaborations

Posted on by Damon Seils

NIH Collaboratory DRN Handout

The NIH Collaboratory Distributed Research Network (DRN) is soliciting queries from investigators at academic institutions, federal agencies, and not-for-profit organizations. The DRN facilitates innovative, multi-institutional collaborations for large, longitudinal observational studies and can support randomized trials.

A new handout from the NIH Collaboratory Coordinating Center summarizes the capabilities of the DRN and connects readers to more information, including examples of recent collaborations that leveraged the DRN to answer important questions.

Using a distributed analysis approach, the DRN enables investigators to collaborate with health plan–based research data partners who participate in the FDA’s Sentinel System. These research data partners have access to large sets of administrative claims data and, in some cases, linked clinical data. Also, because the research partners have direct identifiers and a relationship with potential participants, the DRN enables investigators to conduct prospective longitudinal observational studies.

Two recent studies from the DRN highlighted multi-institutional collaborations that used administrative data and claims to define populations, identify outcomes, and generate hypotheses in support of pragmatic clinical trials and other prospective studies. Another recent study used national claims data from the DRN for more than 73 million pediatric visits across the United States to explore declines in potentially inappropriate antibiotic dispensing, a major public health priority.

For more information about the DRN and opportunities for collaboration, contact nih-collaboratory@dm.duke.edu.

Support for the DRN is provided within the NIH Collaboratory by the NIH Common Fund through a cooperative agreement from the Office of Strategic Coordination within the Office of the NIH Director.

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

Posted on by Karen Staman

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.

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

Posted on by Damon Seils

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 NIH Collaboratory Trials.

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 NIH Collaboratory Trial

EMBED NIH Collaboratory Trial

PPACT NIH Collaboratory Trial

PRIM-ER NIH Collaboratory Trial

PROVEN NIH Collaboratory Trial

SPOT NIH Collaboratory Trial

STOP CRC NIH Collaboratory Trial

TiME NIH Collaboratory Trial

TSOS NIH Collaboratory Trial

December 12, 2019: Two New Studies Highlight Feasibility of Using the Distributed Research Network to Support Pragmatic Trials

Posted on by Damon Seils

Two new studies from the NIH Collaboratory’s Distributed Research Network (DRN) demonstrated the feasibility of using administrative data and claims to define populations, identify outcomes, and generate hypotheses in support of pragmatic clinical trials and other prospective studies.

In an analysis of data for 53,000,000 patients from 3 health insurers, researchers evaluated the feasibility of using claims to identify the incidence of chemotherapy-induced peripheral neuropathy (CIPN). The findings highlight challenges with the administrative codes currently used by clinicians to identify CIPN. The data may also be helpful in generating hypotheses about risk factors and treatment effectiveness in future research.

The study was supported by a grant from the National Cancer Institute and was published online ahead of print in Supportive Care in Cancer.

In another study from the DRN, published last week in PLoS One, researchers used health plan data for more than 750,000 patients to investigate statin use in older adults with and without cardiovascular disease and/or diabetes. Evidence for the appropriateness of statin use in adults older than 75 years is limited. The researchers found that statin initiation was low in the study population, especially for primary prevention of cardiovascular disease, suggesting an opportunity to conduct large pragmatic trials to develop better evidence for clinical guidelines.

Support for both studies was provided within the NIH Collaboratory by the NIH Common Fund through a cooperative agreement from the Office of Strategic Coordination within the Office of the NIH Director.

December 6, 2019: Millions More People, Stronger Collaborations: The New and Improved NIH Collaboratory Distributed Research Network (Richard Platt, MD, Kevin Haynes, PharmD, Denise Boudreau, PhD, Jerry Gurwitz, MD, Christopher Granger, MD)

Posted on by Gina Uhlenbrauck

Speakers

Richard Platt, MD, MS
Professor and Chair
Harvard Medical School
Department of Population Medicine

Kevin Haynes, PharmD, MSCE
Principal Scientist
HealthCore

Denise Boudreau, PhD
Senior Scientific Investigator
Kaiser Permanente Washington Health Research Institute

Jerry H. Gurwitz, MD
Professor of Medicine, Family Medicine and Community Health, and Population & Quantitative Health Sciences
University of Massachusetts Medical School
Executive Director, Meyers Primary Care Institute

Christopher B. Granger, MD
Professor of Medicine
Duke University

Topic

Millions More People, Stronger Collaborations: The New and Improved NIH Collaboratory Distributed Research Network

Keywords

Embedded clinical research; Distributed research network; Administrative claims data; Multisite research; Sentinel System; Electronic health data; National registries; Common data model; Curated research data

Key Points

  • The NIH Collaboratory Distributed Research Network (DRN) enables investigators funded by the NIH and other not-for-profit sponsors to collaborate with investigators based in health plans that participate in the FDA’s Sentinel System.
  • Examples from an array of real-world research studies highlight strengths of conducting collaborative research using the DRN.
  • Among the DRN’s attributes are the abilities to embed a randomized clinical trial in real-world clinical settings, to direct outreach to providers and patients/families, and to determine feasibility with high accuracy to allow confidence in planning of ambitious clinical trials.

Discussion Themes

The DRN is optimized for multicenter research and depends on partnerships. It was developed to enable productive research collaborations.

How do investigators who are not embedded in participating health systems learn to work effectively in the DRN?

Read more about the NIH Collaboratory’s DRN.

Tags
#pctGR, @Collaboratory1, @DeptPopMed, @HealthCoreRWE