October 18, 2022: Richesson to Present on EHR-Based Phenotyping at IMPACT Collaboratory Grand Rounds

Headshot of Rachel RichessonRachel Richesson, cochair of the NIH Pragmatic Trials Collaboratory’s Electronic Health Records (EHR) Core, will present this week at IMPACT Collaboratory Grand Rounds.

The virtual session, “Developing Standards and Quality Metrics for Clinical Phenotyping Using EHR Data in Pragmatic Clinical Trials,” will be held on Thursday, October 20, 2022, at 12:00 pm eastern.

Richesson is a professor of learning health sciences in the University of Michigan School of Medicine. She is working with the EHR Core to develop standards and quality metrics for EHR-based phenotyping, the topic of her upcoming Grand Rounds presentation.

Zoom Details for IMPACT Grand Rounds:

  • Please click the link to join the webinar: https://hebrewseniorlife.zoom.us/j/97344810673
  • Or iPhone one-tap: US: +13126266799,,97344810673#  or +14702509358,,97344810673#
  • Or Telephone: US: +1 312 626 6799  or +1 470 250 9358
  • Webinar ID: 973 4481 0673

Podcast July 8, 2022: FDA Draft Guidance on Real-World Evidence (John Concato, MD, MS, MPH)

This podcast continues the discussion with Dr. John Concato as he discusses the FDA draft guidance on real-word evidence. Click on the recording below to listen to the podcast.

Want to hear more? View the full Grand Rounds presentation.

For alerts about new episodes, subscribe free on Apple Podcasts or SoundCloud. Read the transcript.

June 24, 2022: FDA Draft Guidance on Real-World Evidence (John Concato, MD, MS, MPH)

Speaker

John Concato, MD, MS, MPH
Associate Director for Real-World Evidence Analytics
Office of Medical Policy (OMP)
Center for Drug Evaluation and Research (CDER)
Food and Drug Administration (FDA)

 

 

Keywords

Big data; Real-word evidence; Real-world data; 21st Century Cures Act; FDA Draft Guidance

 

Key Points

  • Big Data, a term first used in the 1990s, leverages modern technology to increase the quantity, forms, speed, and capability to manipulate large-scale data. Real-world data (RWD) is a term with specific regulatory implications referring to health care data routinely collected from a variety of sources. Real-world evidence (RWE) is clinical evidence derived from analysis of RWD regardless of study design.
  • Terminology is important in research work, and we should strive to be as precise as possible with the terminology we use.
  • With the 21st Century Cures Act of 2016, the FDA established a program to evaluate the potential use of real-world evidence to support new indications for drugs and satisfy post-approval study requirements.
  • In 2021, the FDA issued 4 draft guidance documents for Real-world data and Real-world evidence intended to guide the selection and management of data sources to appropriately address the study question and support decision-making for drug and biological products.

Discussion Themes

– Could real-world data sources be certified and preclude the need for submission of source data on a study specific basis? From the FDA point-of-view, while reliability can be more readily evaluated and would tend to be more stable, the relevance to a particular study could not be determined as easily.

– While there can be a reflex that says we can never be sure about major confounding, it should not be the miasma of the 21st century. A thoughtful approach that considers the characteristics that matter is the best approach.

 

Read Dr. Concato’s publication Randomized, observational, interventional, and real-world—What’s in a name? and the FDA Draft Guidance for RWD/RWE.

Tags

#pctGR, @Collaboratory1

December 15, 2021: This Friday in PCT Grand Rounds, Cybersecurity and Compliance in Clinical Research and Healthcare

Headshot of Dr. Eric Perakslis
Dr. Eric Perakslis

In this Friday’s PCT Grand Rounds, Dr. Eric Perakslis of Duke University will present “Cyberthreat, Cybersecurity and Cyber Compliance in Clinical Research and Healthcare: One Size Fits None.” The Grand Rounds session will be held on Friday, December 17, at 1:00 pm eastern.

Dr. Perakslis is the chief science and digital officer for the Duke Clinical Research Institute and the chief research technology strategist in the Duke University School of Medicine. Join the online meeting.

October 5, 2021: New Article Identifies Challenges and Prerequisites for Using Electronic Health Record Systems for Pragmatic Research

JAMIA Cover

In a new NIH Collaboratory study, 20 NIH Collaboratory Trials responded to a survey about challenges encountered when using the electronic health record (EHR) for pragmatic clinical research. The goal of the study was to elucidate challenges and develop solutions—or prerequisites for pragmatic research—to enable healthcare system leaders, policy makers, and EHR designers to improve the national capacity for generating real-world evidence.

The article was published in the Journal of American Medical Informatics Association (JAMIA).

The challenges identified by the projects fell into 6 broad themes, including inadequate collection of patient-centered data, lack of functionality for structured data collection, lack of standardization, lack of resources to support customization, difficulties aggregating data from multiple sites, and difficult and inefficient access to EHR data.

Researchers from the NIH Collaboratory’s EHR Core and colleagues from the Patient-Centered Outcomes and the Health Care Systems Interactions Core Working Groups discussed the issues and iterated possible solutions. The authors developed the following prerequisites for the conduct of pragmatic research:

  • Integrate collection of patient-centered data into EHR systems
  • Facilitate structured research data collection by leveraging standard EHR functions, usable interfaces, and standard workflows
  • Support creation of high-quality research data by using standards
  • Ensure adequate IT staff to support embedded research
  • Create aggregate, multidata type resources for multisite trials
  • Create reusable and automated queries

The authors argue for the ability to tailor EHR systems to enable the collection of patient-centered outcomes and the extraction of high-quality, standardized data. Although the primary uses of the data are for clinical care and billing, high-quality data from the EHR also have the potential to improve clinical care and population health by providing reliable evidence and to support pragmatic research and learning within and across healthcare systems.

Read the full article.

This work was supported within the National Institutes of Health (NIH) Health Care Systems Research Collaboratory by the NIH Common Fund through cooperative agreement U24AT009676 from the Office of Strategic Coordination within the Office of the NIH Director. This work was also supported by the NIH through the NIH HEAL Initiative under award number U24AT010961.

 

July 6, 2021: New Quick Start Guide Offers Advice for Partnering With Healthcare System Leaders

The NIH Collaboratory is pleased to share a new resource to help clinical investigators successfully partner with healthcare system leaders. The Quick Start Guide for Researcher and Healthcare Systems Leader Partnerships provides advice from NIH Collaboratory and healthcare system leadership and serves as an annotated table of contents for the Living Textbook, pointing readers to essential content.Quick Start Guide for Partnerships

The Quick Start Guide is part of a series of tools intended to support the successful conduct of ePCTs within healthcare systems. The first guide in the series, the Quick Start Guide for Investigators, is designed for clinical investigators interested in learning how to conduct an ePCT. The NIH Collaboratory Coordinating Center is developing more Quick Start Guides for different audiences and use cases.

July 1, 2021: NIH Collaboratory Leadership Asks, ‘Is Learning Worth the Trouble?’

Cover of the New England Journal of MedicineIn an article published today in the New England Journal of Medicine, Drs. Richard Platt, Adrian Hernandez, and Greg Simon of the NIH Collaboratory discuss barriers to healthcare system participation in embedded research and strategies for improvement.

“We advocate creating a robust national [embedded pragmatic clinical trial] capability to generate evidence to guide decisions by patients, clinicians, health systems, and regulators and respond to urgent national health crises, like COVID-19 or the opioid crises,” the authors wrote.

The article recommends a 4-pronged strategy that researchers and funders should consider to increase healthcare system participation in pragmatic clinical trials:

  • Reimburse for the additional costs of trial participation.
  • In some highly engaged systems, support permanent, reusable infrastructure.
  • Offload research-specific tasks to minimize burden on sites (such as IRB oversight, obtaining informed consent, and mailing medications to participants).
  • Assign and promote reputational benefit for these activities.

In another perspective piece by Simon, Platt, and Hernandez published in the April 2020 issue of the journal, the authors explored why randomized A vs B comparisons remain uncommon in clinical trials.

October 23, 2020: Outpatient Clinical Decision Support – An Evidence-Based Implementation Framework (Patrick O’Connor, MD, MA, MPH; JoAnn Sperl-Hillen, MD)

Speakers

Patrick O’Connor, MD, MA, MPH
Senior Clinical Investigator
HealthPartners Institute

JoAnn Sperl-Hillen, MD
Senior Clinical Investigator
HealthPartners Institute

Topic

Outpatient Clinical Decision Support – An Evidence-Based Implementation Framework

Keywords

Clinical decision support; Electronic health record (EHR); Automated tools; Web applications; Clinical informatics

Key Points

  • A well-designed clinical decision support (CDS) system should fire only when there is a potential large benefit, such as a cardiovascular benefit for patients with a reversible risk. The CDS trigger should be patient-centric, and the system should save clinician time and improve the quality of care.

  • The CDS in question was designed for use in cardiovascular (CV) disease to:

    • Identify and target individuals with the greatest potential for a CV benefit and prioritize CV risk factors based on potential benefit.

    • Display personalized treatment options (eg, medication intensification, behavioral/lifestyle change, safety alerts, referrals, and testing due).

    • Provide tools to both the patient and clinician to support patient engagement and shared decision-making.

Discussion Themes

How are the interventions prioritized in the CDS system? What about decision-making across other clinical domains?

What do you see as the drivers of uptake and adoption of CDS with triggers compared with telehealth?

What clinic challenges did you encounter after the onset of COVID-19?

Read more in Clinical Decision Support Directed to Primary Care Patients and Providers Reduces Cardiovascular Risk: A Randomized Trial (J Am Med Inform Assoc, 2018) and NCT01420016 (ClinicalTrials.gov).

Tags

#pctGR, @Collaboratory1

September 11, 2020: Launching CONNECTS: Collaborating Network of Networks for Evaluating COVID-19 and Therapeutic Strategies (Gordon Bernard, MD; Sonia Thomas, DrPH)

Speakers

Gordon R. Bernard, MD
CONNECTS ACC Science Unit P
Professor of Medicine
Executive Vice President for Research
Senior Associate Dean for Clinical Science
Vanderbilt University Medical Center

Sonia Thomas, DrPH
CONNECTS ACC Principal Investigator
Senior Research Statistician
RTI International

Topic

Launching CONNECTS: Collaborating Network of Networks for Evaluating COVID-19 and Therapeutic Strategies

Keywords

COVID-19; CONNECTS; NHLBI; Collaborative research; Data sharing; Adaptive trials; Data standardization; ACTIV; Therapeutic agent prioritization

Key Points

  • The Collaborating Network of Networks for Evaluating COVID-19 and Therapeutic Strategies (CONNECTS) is a research partnership coordinated by the Research Triangle Institute, Vanderbilt University Medical Center, and the National Heart, Lung, and Blood Institute (NHLBI) of the NIH.
  • CONNECTS aims to build on existing clinical research networks to better understand the risk of severe illness from COVID-19 and to identify therapies that will slow or halt the disease progression and speed recovery. Studies will enroll participants with health conditions that are known to increase their risk for severe complications from COVID-19.
  • The immediate goal is to design and implement master protocol-driven adaptive clinical trials, including outpatient, inpatient, and recovering master protocols.
  • CONNECTS is part of a larger ecosystem in the Department of Health and Human Services that includes the FDA, CDC, BARDA, Operation Warp Speed, and NIH. More than 34 trial networks and 1,000 sites are participating in CONNECTS.

Discussion Themes

Are the CONNECTS resources, such as the common data elements manual, draft protocols, and case report forms, publicly available?

In your effort to reach underrepresented communities, have you considered collaborating with Historically Black Colleges and Universities (HBCUs), particularly those that conduct health research?

While COVID-19 is providing you with plenty to focus on, do you see the potential for sustainability of CONNECTS beyond this pandemic?

Read more about CONNECTS.

Tags

#pctGR, @Collaboratory1