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Engagement in Research for Pragmatic Clinical Trials3/30/2020Guidance documentThis document provides considerations for investigators designing and conducting PCTs as well as institutional review boards (IRBs) overseeing them.
  
Living Textbook Grand Rounds Series: Part 3-Tips for Putting Together a Successful PCT Grant Application 3/27/2020Grand RoundsDr. Weber presents best approaches to developing a successful grant application for embedded PCTs.
  
Living Textbook Grand Rounds Series: Part 3-Tips for Putting Together a Successful PCT Grant Application 3/27/2020VideoDr. Weber presents best approaches to developing a successful grant application for embedded PCTs.
  
Clinical Trials in the Time of COVID-19 3/20/2020Grand RoundsA Duke University panel discusses the impact of the COVID-19 outbreak on the conduct of clinical trials.
  
Intraclass Correlation Coefficient Cheat Sheet3/16/2020HandoutAn introductory description of the intraclass correlation coefficient (ICC), a descriptive statistic that is important for the design and analysis of cluster-randomized trials
  
Impact of Regulatory Guidance on Evaluating Cardiovascular Risk of New Glucose-Lowering Therapies to Treat Type 2 Diabetes Mellitus–Lessons Learned and Future Directions 3/13/2020Grand RoundsDrs. Sharma and Granger discuss aspects of the regulatory guidance for evaluating the cardiovascular risk of new glucose-lowering treatments for type 2 diabetes.
  
Impact of Regulatory Guidance on Evaluating Cardiovascular Risk of New Glucose-Lowering Therapies to Treat Type 2 Diabetes Mellitus–Lessons Learned and Future Directions 3/13/2020VideoDrs. Sharma and Granger discuss aspects of the regulatory guidance for evaluating the cardiovascular risk of new glucose-lowering treatments for type 2 diabetes.
  
Creating a Learning Health System Through Randomization 3/6/2020Grand RoundsDr. Horwitz describes methods for using randomization in health system quality improvement (QI) initiatives to promote a learning healthcare system.
  
Creating a Learning Health System Through Randomization 3/6/2020VideoDr. Horwitz describes methods for using randomization in health system quality improvement (QI) initiatives to promote a learning healthcare system.
  
LIRE Public Use Dataset and Data Dictionary3/5/2020Public use datasetLIRE Public Use Dataset and Data Dictionary
  
LIRE Computable Phenotypes3/5/2020Computable phenotypeLIRE Computable Phenotypes
  
AcuOA Ethics and Regulatory Discussion2/28/2020Meeting summaryThis document contains the meeting minutes and supplementary materials for the AcuOA Demonstration Project
  
NOHARM Ethics and Regulatory Discussion2/28/2020Ethics and regulatory documentationThis document contains the meeting minutes and supplementary materials for the NOHARM Demonstration Project
  
FM TIPS Ethics and Regulatory Discussion2/28/2020Ethics and regulatory documentationThis document contains the meeting minutes and supplementary materials for the FM TIPS Demonstration Project
  
OPTIMUM Ethics and Regulatory Discussion2/28/2020Ethics and regulatory documentationThis document contains the meeting minutes and supplementary materials for the OPTIMUM Demonstration Project
  
Living Textbook Grand Rounds Series: Part 2-Preparing for the Unknown: Conducting Pragmatic Research in Real-World Contexts2/28/2020Grand RoundsAn expert panel discusses approaches to preparing, monitoring, and evaluating pragmatic clinical trials embedded in real-world clinical settings.
  
Living Textbook Grand Rounds Series: Part 2-Preparing for the Unknown: Conducting Pragmatic Research in Real-World Contexts2/28/2020VideoAn expert panel discusses approaches to preparing, monitoring, and evaluating pragmatic clinical trials embedded in real-world clinical settings.
  
TiME Closeout Data and Resource Sharing Checklist2/26/2020Data and Resource Sharing ChecklistTiME Closeout Data and Resource Sharing Checklist
  
TiME Closeout Snapshot2/26/2020HandoutCloseout snapshot of the TiME Demonstration Project
  
ePCT Factsheet 20202/25/2020HandoutDouble-sided information sheet about the NIH Collaboratory and pragmatic clinical trials
  
Nudge Study Updates2/21/2020Grand RoundsDrs. Bull and Ho discuss the progress and challenges of the Personalized Patient Data and Behavioral Nudges to Improve Adherence to Chronic Cardiovascular Medications (Nudge) Demonstration Project.
  
Nudge Study Updates2/21/2020VideoDrs. Bull and Ho discuss the progress and challenges of the Personalized Patient Data and Behavioral Nudges to Improve Adherence to Chronic Cardiovascular Medications (Nudge) Demonstration Project.
  
NIH Collaboratory Communication Channels2/19/2020HandoutNIH Collaboratory Communication Channels graphic
  
Do Our Current Research Models Meet the Needs of a Learning Health Care System? 2/14/2020Grand RoundsDr. Atkins discusses how new research models and health system partnerships can advance a learning healthcare system.
  
Do Our Current Research Models Meet the Needs of a Learning Health Care System? 2/14/2020VideoDr. Atkins discusses how new research models and health system partnerships can advance a learning healthcare system.
  
Using Nudges to Improve the Delivery of Health Care 2/7/2020Grand RoundsDr. Patel discusses how nudges can be designed to help clinicians with evidence-based care decisions and help patients increase engagement and change health behaviors.
  
Using Nudges to Improve the Delivery of Health Care 2/7/2020VideoDr. Patel discusses how nudges can be designed to help clinicians with evidence-based care decisions and help patients increase engagement and change health behaviors.
  
Using Nudges to Improve the Delivery of Health Care2/7/2020Podcast
  
Design and analytic considerations for using patient-reported health data in pragmatic clinical trials: report from an NIH Collaboratory roundtable2/6/2020Journal articlePublication from the ADAPTABLE supplement
  
HiLo Study Snapshot2/5/2020HandoutStudy snapshot of the HiLo Demonstration Project
  
ePCT Quick Start Guide2/5/2020HandoutA guide designed for clinical investigators interested in learning how to conduct an embedded pragmatic clinical trial (ePCT)
  
NIH Implementation Team Chart2/5/2020HandoutThis document lists the active members of the NIH Implementation Team
  
LIRE Closeout Data and Resource Sharing Checklist2/3/2020Data and Resource Sharing ChecklistLIRE Closeout Data and Resource Sharing Checklist
  
Living Textbook Grand Rounds Series Part 1: Pragmatic Clinical Trials: How Do I Start?1/31/2020Grand RoundsDrs. Simon and Curtis discuss how PCTs are different and why we need them, and important things to consider when developing your pragmatic research question and engaging with stakeholders.
  
Living Textbook Grand Rounds Series Part 1: Pragmatic Clinical Trials: How Do I Start? 1/31/2020VideoDrs. Simon and Curtis discuss how PCTs are different and why we need them, and important things to consider when developing your pragmatic research question and engaging with stakeholders.
  
NIH Collaboratory Distributed Research Network (DRN) Handout1/30/2020HandoutNIH Collaboratory Distributed Research Network (DRN) Handout
  
Design and implementation of a clinical decision support tool for Primary Palliative Care for Emergency Medicine (PRIM-ER)1/28/2020Journal articlePublication from the PRIM-ER Demonstration Project
  
Cardiovascular Trials Over 2 Decades: Progress on Pragmatism? 1/24/2020Grand RoundsDr. Ezekowitz describes recent progress in pragmatism in cardiovascular trials.
  
Cardiovascular Trials Over 2 Decades: Progress on Pragmatism? 1/24/2020VideoDr. Ezekowitz describes recent progress in pragmatism in cardiovascular trials.
  
Assessment of the Human Systemic Absorption of Sunscreen Active Ingredients: FDA-Sponsored Randomized Clinical Trial1/17/2020Grand RoundsDr. Matta describes recent assessments of systemic absorption of sunscreen active ingredients in an FDA-sponsored RCT.
  
Assessment of the Human Systemic Absorption of Sunscreen Active Ingredients: FDA-Sponsored Randomized Clinical Trial1/17/2020VideoDr. Matta describes recent assessments of systemic absorption of sunscreen active ingredients in an FDA-sponsored RCT.
  
Pragmatic Trials of Behavioral Economic Interventions to Increase Colorectal Cancer Screening1/10/2020Grand RoundsDr. Mehta discusses how principles of behavioral economics can be used to help increase rates of colorectal cancer screening.
  
Pragmatic Trials of Behavioral Economic Interventions to Increase Colorectal Cancer Screening1/10/2020VideoDr. Mehta discusses how principles of behavioral economics can be used to help increase rates of colorectal cancer screening.
  
Statement by Individual Leaders and Investigators Involved in Pragmatic Clinical Trials Embedded in Healthcare Systems1/9/2020Response to Draft NIH Data Sharing Policy
  
Considerations for using distributed research networks to conduct aspects of randomized trials1/2/2020Journal articlePublication from the Distributed Research Network
  
Ethics and collateral findings in pragmatic clinical trials1/1/2020Journal articlePublication from the MOTIFS supplement
  
Response to Open Peer Commentaries on 'Ethics and collateral findings in pragmatic clinical trials'1/1/2020Journal articlePublication from the MOTIFS supplement
  
Evaluation of a Level I trauma center provider training in alcohol brief intervention delivery within a 25-site trial of screening and intervention for PTSD and related comorbidity12/29/2019Journal articlePublication from the TSOS Demonstration Project
  
EMBED Update: Challenges and Solutions12/13/2019Grand RoundsDrs. Melnick and D’Onofrio discuss challenges and solutions in their EMBED Demonstration Project.
  
EMBED Update: Challenges and Solutions12/13/2019VideoDrs. Melnick and D’Onofrio discuss challenges and solutions in their EMBED Demonstration Project.
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