pragmatic clinical trials

Grand Rounds July 18, 2025: State of Clinical Trials: An Analysis of ClinicalTrials.gov (Adrian F. Hernandez, MD, MHS; Rebecca D. Sullenger, MPH; Sara Bristol Calvert, PharmD; Karen Chiswell, PhD; Christopher J. Lindsell, PhD)

Posted on by Sophia Ramirez

Speakers:

Adrian F. Hernandez, MD, MHS
Executive Director
Duke Clinical Research Institute

Rebecca D. Sullenger, MPH
Duke University School of Medicine
MD Student | Class of 2026

Panelists:

Sara Bristol Calvert, PharmD
Director of Projects
Clinical Trials Transformation Initiative

Karen Chiswell, PhD
Statistical Scientist
Duke Clinical Research Institute

Christopher J. Lindsell, PhD
Director, Data Science and Biostatistics
Duke Clinical Research Institute

Keywords

Clinical Trials; Enrollment; Pragmatic Clinical Trials; Policy; Data Science

Key Points

  • A study of clinical trials from 2007 to 2010 found that the field was dominated by small trials and contained significant heterogeneity in methodological approaches, including reported use of randomization, blinding, and Data Monitoring Committees.
  • Clinical trials in the United States may be limited by legal, regulatory, and cost-related barriers. In a study of patient enrollment for cardiovascular clinical trials, the authors concluded that the U.S. had more trial sites than Eastern Europe or South America, but enrolled significantly fewer patients per site. These trends highlight the need for improved clinical trial infrastructure.
  • The presenters noted several promising trends in the field: growth in pragmatic clinical trials; high interest in clinical trial innovation from regulatory bodies and funding agencies; and the rapidly evolving capacity of clinical trials, particularly around accessibility.
  • The presenters provided an updated picture of the clinical trials landscape in the U.S., based on retrospective analyses of interventional clinical trials registered on ClinicalTrials.gov between 2018 and 2024.
  • They found that many trials remain small, lack a control group, and are incomplete after 5 years. Although small clinical trials without controls may be appropriate or necessary in specific contexts, such trials are also less likely to produce actionable data.
  • National policies prioritizing a more rapid, rigorous evidence generation system will likely be necessary to create a clinical trial ecosystem best equipped to advance public health.
  • In light of these insights, the team shared 5 potential policy approaches to improve the evidence-generation system in the U.S.:
    • Streamline trial start-up processes, institutional review board approvals, and contracting;
    • Enable scalable technologies to support greater participation;
    • Invest in modern clinical trial design strategies;
    • Require public reporting of key performance indicators and pay-for-performance results; and
    • Create stronger data sharing requirements and accountability rules.

Discussion Themes

Though the team utilized existing fields in ClinicalTrials.gov for their data, future research may utilize the key word search (i.e. adaptive platform trials) or natural language processing to investigate the state of clinical trials.

The value of small (<100 participants) trials was debated by the panelists. Though they do have a time and place, the high proportion of Phase III trials that enrolled less than 100 participants was surprising and concerning.

There are some limitations to ClinicalTrials.gov, namely in data entry. The more complex the trial, the more difficult it is to submit in a timely fashion. The system may post a barrier to embracing modern clinical trial design strategies.

Academia will also need to make policy changes to facilitate a healthier clinical trials ecosystem. The way career development and promotion pathways are structured, researchers are incentivized to lead small, potentially duplicative trials. Institutions need to reward, compensate, and value individual contributions to large-scale programs; i.e., the informative trial over the individually led trial.

Grand Rounds March 14, 2025: Spillover Due to Constraints on Care Delivery: A Potential Source of Bias in Pragmatic Clinical Trials (Sean Mann)

Posted on by Sophia Ramirez

Speaker

Sean Mann
Senior Policy Analyst
RAND Corporation

Keywords

Development Economics; Spillover; Bias; Pragmatic Clinical Trials

Key Points

  • Individually randomized, parallel-group embedded pragmatic trials randomly assign patients to a new healthcare intervention or to a control group that receives some form of usual care. They take place in real-world health settings, where clinical resources can be scarce.
  • If an intervention increases patient use of scarce resources – e.g., appointments, hospital beds, provider attention – this can reduce the availability of those resources for the control group and bias results. This is known as negative spillover, or crowding out, in the field of development economics. However, spillover due to resource constraints is absent from the major frameworks that inform clinical trial methods.
  • 4 conditions must be met for spillover to affect trial results: 1) Resources are shared across trial arms 2) Care delivery resources are constrained or limited in some way 3) The intervention being studied affects utilization of the scarce resource 4) Having fewer resources available to care for patients affects their health outcomes. These conditions are fairly common in pragmatic trials.
  • Spillover is not just a source of bias; it has implications for patient safety. If negative spillover occurs, patients who are assigned to a control arm are no longer receiving usual care as it’s commonly understood. Mann provided strategies that research teams can use to detect spillover or avoid it entirely, including utilizing a cluster-randomized design or a demand-balanced trial design.
  • Spillover remains hypothetical, and positive spillover is also possible. Study results affected by spillover can still be a valid indication that an intervention affects care utilization.
  • In many pragmatic trials, spillover is likely negligible. Mann and his colleagues at Rand are trying to help determine when spillover concerns should prompt changes to study design or justify additional data collection and analysis. They recently published a paper in Trials that explores the issue in further detail: Mann, S. Negative spillover due to constraints on care delivery: a potential source of bias in pragmatic clinical trials. Trials 25, 833 (2024). https://doi.org/10.1186/s13063-024-08675-9

Discussion Themes

While the Cochrane Risk of Bias Tool v. 2.0 (RoB 2) can be useful for looking at disparities in the level of care provided to the control group versus the intervention group, it exclusively looks at bias due to lack of blinding.

IRB applications could be expanded to include further questions about how resources are being used at a study site, how a study may potentially increase demands on those resources, and how it might affect others who are receiving those health services.

Clinical settings aren’t necessarily a zero sum game; negative spillover will apply in certain contexts, while in others the presence of an intervention will lead to positive spillover or no effect.

Grand Rounds December 16, 2022: The Use of EHR-Agnostic Clinical Decision Support to Prevent Thromboembolism in Hospitalized Medically Ill Patients (Alex C. Spyropoulos, MD, FACP, FCCP, FRCPC; Jeffrey Solomon, BFA)

Posted on by Elizabeth Mccamic

Speakers

Alex C. Spyropoulos, MD, FACP, FCCP, FRCPC
Professor of Medicine – The Donald and Barbara Zucker School of Medicine at Hofstra/Northwell
Professor – Institute of Health System Science – The Feinstein Institutes for Medical Research
System Director – Anticoagulation and Clinical Thrombosis Services
Northwell Health at Lenox Hill Hospital

Jeffrey Solomon, BFA
Senior Director, Usability Lab
Feinstein Institutes for Medical Research, Northwell Health, Manhasset, NY

 

 

Keywords

Pragmatic Clinical Trials, Cluster Randomized Trial, EHR solutions

 

Key Points

  • The majority of hospital-acquired Venous Thromboembolism (VTE) occurs in non-surgical medical inpatients, but Thromboprophylaxis for medically ill patients during and after hospital stays is underutilized. Electronic alerts incorporating VTE risk models could increase appropriate use of Thromboprophylaxis and reduce symptoms of VTE.
  • The study team’s health informatics group developed a novel clinical decision support (CDS) tool, called IMPROVE-DD VTE CDS, which can be integrated into different electronic health record (EHR) systems. The effectiveness of the intervention was then evaluated through a cluster randomized trial at four academic tertiary hospitals from December 21, 2020 to January 21, 2022.
  • This trial tested the hypothesis that the use of a platform-agnostic, EHR-embedded VTE risk model with integrated CDS would 1) increase rates of appropriate Thromboprophylaxis, and subsequently 2) reduce thromboembolism, compared to usual medical care in hospitalized, medically-ill patients.
  • The study team developed the tool using high-quality evidence from randomized trials related to risk factors for subpopulations and guideline recommendations. The solution’s interface was developed using workflow analysis, multiple iterations of the tool and usability testing.
  • The trial is the first to show that a universal EHR-integrated CDS tool using a validated VTE risk model (IMPROVE-DD) had a high adoption rate (77%), significantly increased rates of in-hospital appropriate Thromboprophylaxis and significantly reduced major Thromboembolic events without an increase in major bleeding at 30 days post-discharge compared to usual medical care. Thirty-day mortality was higher in the intervention hospital group.
  • The study team spoke about the tension that often exists between solutions that are tightly integrated into a specific EHR and the ability to disseminate them widely. Developers worked to find the “sweet spot” in a solution that balanced the two priorities. The tool’s success is attributed to workflow analysis, rapid prototyping, usability testing and its integration with the EHR.
  • The high baseline rate of appropriate in-hospital and at-discharge Thromboprophylaxis in the academic control hospitals suggests that the solution has an even greater potential for positive impact at non-academic or rural hospital settings.

 

Discussion Themes

– How was usability tested and how does the tool fit into a clinician’s daily routine? With every iteration of testing, the team worked to identify barriers in provider workflow. The number of testing rounds, as well as the quality of usability testing, was critical in understanding workflows and the best moment to launch the tool. The team also engaged with a diverse array of providers from multiple hospitals and specialties. It was important to observe behaviors in real time and be open to making changes at multiple points during the design and testing process.

– How did you derive and evaluate the evidence that was used in the IMPROVE-DD VTE CDS tool? The team derived the evidence based on a multivariate analysis from an international prospective registry. The team also conducted multiple external validation projects using the same weights and scores. In doing this, they were able to replicate the data among different populations.

– How can tools like this contribute to clinical decisions based on data for subgroups instead of broader guidelines? The study team is hopeful that this effort and others like it will promote clinical decisions that are based on evidence for patient subgroups. Clinical recommendations should be based on more specific data, as there are public health implications for guideline statements that are too broad.

-What is the explanation for the excess deaths at 30 days in the intervention group? The trial was designed before the COVID-19 pandemic, but it was conducted during the height of the pandemic in New York. Because of rebalancing of physicians, there were more COVID-19 patients in the intervention group. Researchers considered this an epiphenomenon that likely reflects the imbalance of the COVID-19 patients in the intervention group. More analysis is needed to confirm that hypothesis

Tags

#pctGR, @Collaboratory1

Grand Rounds September 16, 2022: Using Nationwide Registries to Conduct Pragmatic Randomized Trials: The DANFLU Program (Tor Biering-Sørensen, MD, PhD, MPH)

Posted on by Elizabeth Mccamic

Speaker

Tor Biering-Sørensen, MD, PhD, MPH
Professor in Translational Cardiology and Pragmatic Randomized Trials
Head of Center for Translational Cardiology and Pragmatic Randomized Trials
Department of Biomedical Sciences
Faculty of Health and Medical Sciences
University of Copenhagen
Head of Cardiovascular Non-Invasive Imaging Research Laboratory
Department of Cardiology
Copenhagen University Hospital – Herlev and Gentofte

 

Keywords

DANFLU-1, Pragmatic Clinical Trials

 

Key Points

  • The Danish Nationwide Registries include the Danish Patient Registry (a registry of every inpatient and outpatient contact in the Danish free-for-all public healthcare system); the Danish Medicines Registry (a registry of every filed prescription at any pharmacy in Denmark including information on pill strength, pack size, etc.); and the Danish Registry of Causes of Death (a registry of long-term clinical outcomes including hospitalizations, outpatient visits, procedures, prescriptions, mortality). Denmark also has registries tracking socioeconomic data such as income and level of education and other types of data that can be linked together for study.
  • Denmark also has a mandatory electronic mailbox (e-BOKs) system that is required for all Danish citizens older than 18 and is linked to each citizen’s social security number. The system is used by approximately 5.8 million people, representing more than 95% of the population. The system is used for priority communications from government agencies, hospitals, banks, and others, and allows for rapid delivery of recruitment letters and implementation interventions
  • The national registries can be used to identify potential study participants who meet specific criteria and the e-BOKs system allows researchers to easily send invitations to potential participants, as well as follow up communications. Researchers can track participants through their medical records regardless of location and through the national registries. This infrastructure can be used to conduct pragmatic Phase II trials, large-scale pragmatic RCTs, such as DANFLU, and nationwide implementation trials.
  • The COlchicine Hypertension Trial (COHERENT) is a pragmatic Phase II trial that looked at only hypertension by using registry data to identify patients that receive at least two hypertension drugs. The DECODE trial used registry data to identify patients with chronic kidney disease.
  • The DANFLU-1 trial is a large-scale pragmatic RCT that looked at high-dose vs standard-dose flu vaccine to test whether high-dose vaccines might reduce hospitalizations among the elderly, age 65 and older. The DANFLU-1 trial evaluated the feasibility of integrating an individually randomized trial into routine seasonal influenza vaccination practice using administrative health registries for data collection. 34,000 study invitations were sent out and 12,551 participants consented and were randomized in the study. One hypothesis-generating outcome was that participants randomized for the high-dose vaccine had a 64% lower risk for hospitalization than the standard-dose vaccine.
  • With the success of DANFLU-1, the team is launching the fully powered DANFLU-2 trial, which will be conducted the next two years, randomizing 208,000 patients over two flu seasons. The team will send out 800,000 invitations. Hospitalization of flu is the primary outcome.
  • The NUDGE-FLU trial is a nationwide implementation study that will randomize all Danish citizens above 65 who receive a free vaccine by Danish government. 1.2 million citizens will be randomized to receive 10 different communications. The aim is to test communication strategies for optimizing the update of the flu vaccine. Another trial is called NUDGE-DM using the same system for identifying patients with diabetes to test communication strategies for optimizing the use of guideline directed medical therapy for T2D patients with established CVD

Discussion Themes

-I was struck by the number of people that were approached and joined the DANFLU study. For most trials it’s 2-4%. What was the type of engagement; were people aware clinicians were involved? These are participants who are already in the vaccine company’s registry. They have been vaccinated and were seeking the flu vaccine. We would not expect this recruitment rate in other trials.

–What clinicians are involved in the trial? It wasn’t the intention to bypass clinicians but the only ones involved are in the study lab and with the vaccine company. We are bypassing the normal ways because we are not in the hospitals. We are using the vaccine clinics where it’s nurses who are administering the vaccine at clinics in all of the cities, not just at hospitals. During the vaccine season they have pop-ups. We can do this work cheaply because we are not using local sites, we are not paying participants. The DANFLU-1 trial was close to $1.5 million U.S. dollars.

-These one-time interventions, like vaccines, contact people, deliver intervention, what about chronic care that is needed for a trial where more monitoring is needed? You can always use the system to identify potential candidates and then guide them to the local cardiology, kidney department. To keep the cost down, we are thinking about how to use vaccine clinics. It was the first try at testing the systems, so now we are testing whether mailing out potential interventions or using the vaccine clinics where they have to go in to draw a blood sample

Learn more

Read about DANFLU-1.

Tags

#pctGR, @Collaboratory1

Grand Rounds August 26: The Diuretic Comparison Project: A Large Pragmatic Clinical Trial (Areef Ishani, MD, MS)

Speaker:

Areef Ishani, MD MS
Director, Primary Care and Specialty Medicine Service Line
Minneapolis VA Health Care System
Professor of Medicine
University of Minnesota

Topic: The Diuretic Comparison Project: A Large Pragmatic Clinical Trial
Date: Friday, August 26, 2022, 1:00-2:00 p.m. ET

 

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June 27, 2022: Special Edition of Contemporary Clinical Trials Offers New Perspectives on Pragmatic and Virtual Clinical Trials

Posted on by Elizabeth Mccamic

Contemporary Clinical TrialslsA special series of articles addressing pragmatic and virtual trials appears this week in the journal Contemporary Clinical Trials and offers practical approaches to the many challenges clinical trials face.

The 14 articles bring together leaders, researchers, biostatisticians, and bioethicists—including members of the NIH Pragmatic Trials Collaboratory—who are rethinking key aspects of the development, conduct, and oversight of clinical trials.

The articles include recommendations and real-world experience on how clinical trials can be done better while maintaining high-quality results using digital technology, direct-to-participant methods, and electronic health records.

The special issue can be found on the Contemporary Clinical Trials website.

Adrian F. Hernandez, MD, MHS, a co-principal investigator for the NIH Pragmatic Trials Collaboratory Coordinating Center, and Tammy Reece, MS, PMP, CCRA, the program’s project director, served as the issue co-editors. Dr. Hernandez is also vice dean and executive director of the Duke Clinical Research Institute and professor of medicine at Duke University. Ms. Reece is a Senior Project Leader in the Government Trials and Networks Group at the Duke Clinical Research Institute.

Following an introduction written by Hernandez, the remaining 13 articles focus on topics including simplification by design, digital technologies and clinical trials, iterative approaches to the use of electronic health records data for large pragmatic studies, ethics and regulatory considerations, and lifestyle and behavioral modification trials.

This body of work offers pragmatic approaches to overcoming the many reasons clinical trials are underperforming, such as high financial costs, long duration, administrative complexity, low recruitment and retention of participants, and difficulty translating knowledge to actual medical care.

“The articles in this issue recognize advances in evidence generation while sharing the challenges and gaps that still need to be addressed,” Hernandez said. “Ultimately, the clinical research ecosystem must improve, not only to keep pace with the advances in science, but to improve public health in meaningful ways.”

“The NIH Pragmatic Trials Collaboratory has been working to re-engineer clinical trials for a decade, yet there is still progress to be made,” Reece said. “Sharing knowledge and innovations across disciplines is critical to continue the momentum of transformation toward a learning health system.”

June 14, 2022: Including Diverse Participants in Pragmatic Clinical Trials

Posted on by Elizabeth Mccamic

In an interview at the NIH Pragmatic Trials Collaboratory Steering Committee meeting in April, Drs. Rosa Gonzalez-Guarda, Rachel Gold, and Karen A. Kehl discussed the importance of including diverse participants in pragmatic clinical trials and the challenges investigators and community health centers face engaging underrepresented populations in research.

During the discussion, Gonzalez-Guarda, Gold, and Kehl identified some of the challenges investigators must address in order to include diverse populations in pragmatic trials, such as inequalities in access to healthcare, under-resourced community health centers and funding mechanisms that do not accommodate research in community settings, and lack of infrastructure for research in settings outside of academic health centers.

“I think the biggest challenge that we have is that we know there are inequities in access to healthcare to begin with so if we are not thoughtful about the integration of pragmatic clinical trials within a system that already lacks accessibility to many populations, I think that is a huge challenge that we need to overcome,” said Gonzalez-Guarda of Duke University.

Changes to the way research is funded is one step that could better support research that includes diverse populations.

“Through the Collaboratory, we have used a lot of collaborative mechanisms that allow some of that building of community-based resources in the planning phases,” said Kehl of the National Institute of Nursing Research. “The Collaboratory and HEAL Initiative have had some particular supplements that are looking just at engaging diverse populations and adding to the diversity and inclusion of a study.”

Other areas to focus on include building relationships within the community, developing partnerships and infrastructure for research at community health centers, and ensuring the study content is of interest to the clinic and patients.

“My experience of 15 years of doing pragmatic trials with community health centers has focused on outcomes that are of most interest to the primary care providers, which is a lot of times going to be around maternal-child health, opioid pain management, hypertension, and diabetes—what the patients are coming in for the most and in a lot of cases [what] the clinics have a quality metric that they have to report on,” said Gold of Kaiser Permanente Center for Health Research.

Gonzalez-Guarda hopes the NIH Pragmatic Trials Collaboratory will help lead the way in putting change into action.

“There’s a lot of expertise already in the Collaboratory and success on engaging diverse populations, not only as participations of those studies [but also] as partners, and those are things that I would love to elevate and integrate into our Living Textbook as well as creating some trainings,” Gonzalez-Guarda said. “Another strategy that we need to think about is diversifying the workforce of individuals and investigators that have the expertise in this area because we do know that makes an impact in terms of encouraging diverse participation and engagement in clinical trials.”.

View the full interview.

See the complete materials from the 2022 Steering Committee meeting.

June 7, 2022: Reflecting on 10 Years of the Health Care Systems Interactions Core

Posted on by Elizabeth Mccamic

The NIH Pragmatic Trials Collaboratory Heath Care Systems Interactions Core supports and facilitates productive collaboration between researchers, clinicians, and health system leaders to conduct effective, relevant embedded pragmatic clinical research.

Health Care Systems Interactions Core Co-Chairs Dr. Eric B. Larson and Dr. Gregory Simon discussed the Core’s progress over the last 10 years in an interview at the NIH Pragmatic Trials Collaboratory Steering Committee meeting in April.

Over the last 10 years, the Health Care Systems Interactions (HCS) Core has allowed researchers to learn about working with healthcare delivery systems. Knowledge that is now common, was unknown when the Core was started, such as how dynamic healthcare delivery systems are and how the capabilities of and changes to the electronic health record can impact pragmatic clinical trials.

Through this type of discovery, the HCS Core has helped researchers become more sensitive to and aware of the priorities of healthcare delivery systems, resulting in better collaboration.

“The researchers’ priorities are usually not the same as the priorities of the people we are working with, whether they are patients, providers, or delivery systems. You have to know what other people’s purpose and drivers are and find a way to adapt,” said Larson. “We have learned and taken pretty seriously this idea of a learning health system with bidirectional engagement from research and from elements of the delivery system.”

The work of the HCS Core and NIH Pragmatic Trials Collaboratory has created a safe haven where researchers can share experiences and advance the field with common learning.

Simon sees the HCS Core as having internal and external missions. The internal mission is to support NIH Collaboratory Trials and be a community where researchers can come together, share their trials and tribulations, and experts in the Core can help these projects be successful, he described.

The external mission is focused on generalizable knowledge and advocacy. The HCS Core has shared knowledge with the research community and funders through publications and meetings and is advocating for research that includes the healthcare delivery system perspective.

“The discussion we are having is not just how do I work with healthcare systems to do my research, but how do I engage with healthcare systems about what research we should be doing, what are the right questions we should be asking for the studies that will be happening 5 years from now not the studies that are already underway,” Simon said.

Another lesson the HCS Core has learned is the importance of being flexible and adjusting. This lesson has been particularly relevant during the COVID-19 pandemic.

“COVID-19 is an extreme case of health system overwhelm, but I think we need to recognize that if we are going to serve people that have been traditionally not been well-served by the healthcare system, we will often be dealing with health systems that are chronically overwhelmed,” said Simon. “How do we do research in those settings? There are some really interesting challenges to think about.”

The HCS Core is focused on continued engagement between researchers and healthcare delivery systems that results in implementable new knowledge.

“My belief is that if we have the upstream involvement and are engaged in research projects that matter to the delivery system from the patients all the way up to the executives, we have a much better chance that when a result is valuable it becomes implementable and spreads to benefit everybody,” Larson said.

View the full interview.

See the complete materials from the 2022 Steering Committee meeting.

May 25, 2022: NOHARM Aims to Change How Patients Manage Pain After Surgery

Posted on by Elizabeth Mccamic

NOHARM, an NIH Pragmatic Trials Collaboratory Trial, is a cluster-randomized, stepped-wedge trial of a bundled intervention that relies heavily on the electronic health record to encourage perioperative patients to consider using nonpharmacologic approaches to manage their postoperative pain. The goal is to diminish patients’ reliance on opioids after surgery and, as a result, reduce rates of inappropriate and prolonged use of opioids.

Dr. Andrea L. Cheville, Co-PI of the Non-pharmacological Options in postoperative Hospital-based And Rehabilitation pain Management (NOHARM) project, discussed the study in an interview during the NIH Pragmatic Trials Collaboratory’s Steering Committee meeting in April.

NOHARM includes 5 steps with 22 clusters randomized to each step. The clusters are defined by surgical type as well as site. The project includes 4 health systems that fall under the Mayo enterprise and share a common electronic health record.

“We have now gone live with 2 of our steps, a total of about 10 clusters, and the surgical types that are included are transplant, cardiac, pulmonary, gynecologic, C-section, orthopedic, and colorectal surgeries,” said Cheville. “The statisticians from the Collaboratory were truly vital allies in parameterizing our choice of procedures and the stepped-wedge so I really cannot call them out enough.”

In May, the project was set to go live with a third step, the automated assignment of a portal-delivered conversation guide to patients.

“The goal of the guide is to educate patients that they are likely to have pain, that it’s important to take seriously and plan for, the benefits and the potential harms of opioid use, and the availability of equally effective, safer nonpharmacologic options that have additional benefits with respect to function and anxiety and sleep quality,” Cheville said.

NOHARM has engaged more than 36,000 patients with a target of roughly 100,000 patients total. Cheville said the project has learned that patients’ receptivity to different pain management options is dynamic over the course of their perioperative journey.

NOHARM, like other trials, has faced challenges related to COVID-19, and the fact that sites may experience surges at different times. A COVID-19 surge at one site can mean that nurses trained in the intervention are deployed elsewhere or that their ability to ingest new information and change practice patterns is stressed and challenged.

“We are trying to find a happy medium between advancing the trial, ensuring high-fidelity delivery, and consistent implementation across all of our clusters while being very respectful to the taxing demands imposed by the COVID-19 epidemic on all of the stakeholder groups,” Cheville said.

Cheville said being part of the NIH Pragmatic Trials Collaboratory has been extremely beneficial for NOHARM, particularly having access to experts who are available to help with methodology, informatics, the electronic health record, parameterization, and statistics.

“If I had to pinpoint one attribute of the Collaboratory it would be the freedom to share our weaknesses, our fears, the things that keep us up at night, with colleagues who are grappling and troubleshooting exactly the same issues in parallel, who truly are walking the walk. Feeling part of a community, that’s been vital for our own psychosocial well-being,” Cheville said.

View the full video here.

NIH Pragmatic Trials Collaboratory 2022 Annual Workshop Critical Questions for Pragmatic Clinical Trialists: Insights From the NIH Pragmatic Trials Collaboratory’s First Decade

The NIH Pragmatic Trials Collaboratory will hold a virtual workshop June 15-16, 2022, to explore questions critical to designing and implementing pragmatic clinical trials conducted within healthcare systems. This workshop is an opportunity to glean the most salient lessons learned from an experienced group of the pragmatic trial investigators who will openly share the challenges they have encountered, solutions they have developed, and thoughts for the future.

The workshop will include 4 moderated webinar discussions with panels of experts that will focus on changes and current best practices regarding the use of electronic health records for pragmatic research, considerations for pragmatic trial study design, how to optimize a 1-year planning phase for a pragmatic trial, and tips for implementing interventions in complex health systems.

All sessions are free and open to the public.

Register today.

See the full schedule.