December 19, 2019 – As the year—and the decade—draws to a close, we take a look back at some of our accomplishments and the ways in which we shared knowledge in 2019.
As detailed in our DCRI Annual Report, 2019 was a busy and productive year. Our faculty and operational staff published more than 1,300 scholarly articles in FY19—the highest number on record for the DCRI. In addition to publishing science in scholarly journals, DCRI representatives shared their knowledge and expertise in plenty of other avenues, including through writing editorials on seminal topics in their respective fields, contributing research that helped shape FDA guidance and other regulatory documents, and presenting at large conferences. Take a look through this article to view some of the year’s highlights.
Providing Wraparound Study Support: Our Services and Capabilities
The DCRI continues to provide capabilities that are critical to the future of efficient and well-designed clinical research, such as taking pragmatic approaches to clinical trials. This year, the DCRI’s pragmatic approach of identifying and recruiting patients through electronic health records resulted in ADAPTABLE successfully meeting its enrollment goal of 15,000 participants. The DCRI also continues its services in areas like adjudication of clinical events from its Clinical Events Classification group and partnering with patients to provide diverse perspectives in research through DCRI Research Together. New this year to the DCRI was the Behavioral Research Intervention Science Center (BRISC), which implements behavioral incentives into studies and provides evidence for what motivates patients and providers to change their behavior. Additional services and capabilities provided by the DCRI are discussed in the following articles:
- The DCRI Arrhythmia Core Lab, which has longstanding expertise in evaluation and adjudication of electrograms and electrocardiograms, is now set to work on more studies that involve wearable devices.
- The DCRI provides advice on best practices via white papers. For example, through the Global Pediatric Clinical Trials Research Network, the DCRI worked directly with sponsors to identify pain points and challenges to pediatric clinical research, and subsequently released a white paper providing recommendations to address these challenges.
- Along with groundbreaking studies, the DCRI also generates new evidence through registries, such as the cv-MOBIUS registry that seeks to enroll and follow 8,500 high-risk patients to understand how lipid management treatments are used in real-world practice.
- The DCRI hosts quarterly DCRI Think Tanks, which are designed to convene diverse stakeholders to tackle the greatest challenges and largest gaps in clinical research. Recently, the DCRI published a paper sharing findings from a think tank on tech-enabled trials.
Sharing Our Expertise: Contributions to Regulatory Documents and Other Recommendations
The DCRI also delivers on our mission to share knowledge through contributing to regulatory documents and other recommendations widely recognized by their fields. This year, work from DCRI pediatrics researchers helped to shape FDA guidance on how to conduct studies in newborns. Several collaborations among the DCRI and other organizations have also helped the FDA to map its strategy and recommendations for using real-world evidence in research. Other key examples of DCRI faculty sharing their expertise to impact their fields include:
- Pediatric Trials Network Studies Lead to FDA Approval of Acyclovir Labeling Supplement
- Few Treatment Guidelines for Heart Disease are Based on Rigorous Study
- DCRI Research Contributes to FDA Approval of First Drug For Rare Disease in Pediatric Patients
- ARLG Study Employs Innovative Model to Test Diagnostics for Extragenital Gonorrhea
- DCRI Patient Preference Research Contributes to FDA Decision
- DCRI Study Honored as Practice-Changing by New England Journal of Medicine
- DCRI Contributes to AHA Statement on HIV and Cardiovascular Disease
- ACC Advocates for Fair Compensation for Cardiologists
- DCRI Receives Grant to Develop Measures for Pain in Infants and Young Children
- DCRI Pediatrician Contributes to Guidance on Pediatric Weight-Loss Surgery
- Data Monitoring Committees Need Complete Data to Protect Patients
Conducting Innovative Research: New Studies and Study Milestones
DCRI teams continued to work diligently on their respective studies. Some teams launched new trials, such as the PREVENTABLE trial, which was awarded $90 million to study the effects of statins on the cognitive function of older adults. Others celebrated the achievement of milestones years in the making; for example, expansive childhood research program ECHO, for which the DCRI acts as a coordinating center, received IRB approval and has already initiated studies. Additional new studies and study milestones included:
- TRANSFORM-HF Pioneers New Type of Clinical Trial
- PRECISE Begins Enrollment, Looks to Improve CT Intervention
- Gene Therapy Trial for Pompe Disease Begins
- DCRI Earns $19M in Funding As Part of National Effort to Address Opioid Crisis
- PTN Receives NIH Funding to Advance Down Syndrome Research
Working Together to Make an Impact: Collaborations and Strategic Partnerships
In addition to new studies, the DCRI has also entered into new collaborations over the last year. Some of these strategic partnerships have been study-related, such as a partnership with Cerner, the world’s largest electronic health record company, to leverage real-world data in clinical research. Others have been related to a general area of expertise, such as the DCRI’s entry into the Digital Therapeutics Alliance. Additional collaborations and partnerships include:
- Duke Joins Baseline Health Consortium to Get Patients More Involved in Research
- DCRI and Responsum Health Announce Collaboration to Connect Uterine Fibroids Patients
- DCRI Teams with American Heart Association to Conduct Pragmatic Clinical Trials and Pursue Implementation Science
Owning Our Perspective: Editorials and Discussion Pieces
From a Viewpoint in JAMA Cardiology from Ann Marie Navar, MD, PhD, which likened medical misinformation surrounding vaccines to fears surrounding statins, to an editorial from Michael Felker, MD, in Circulation that called for more data on the benefits of newer cardio-metabolic drugs, our faculty shared many perspectives this year. A sampling of DCRI stories that covered other editorials and discussion pieces published within the last year include:
- DCRI Researchers Weigh In on Patient Data-Sharing (Eric Peterson, MD, MPH)
- Open Data Critical to Clinical Research (Frank Rockhold, PhD)
- Implantable Cardioverter Defibrillators Still Important in Clinical Practice (Sana Al-Khatib, MD)
- Real-World Evidence Presents Pros and Cons in Assessing Drug Safety (Emily O’Brien, PhD, and Stephen Greene, MD)
- DCRI Researchers Weigh In on Wearables in Heart Failure Care (Adam DeVore, MD, and Adrian Hernandez, MD, MHS)
- To Leverage Power of Machine Learning, Focus on Implementation is Needed (Eric Peterson, MD, MPH)
Presenting New Discoveries: Attendance at Major Conferences
Many DCRI faculty and operations staff attended both the American College of Cardiology Annual Scientific Session, held in March in New Orleans, and the American Heart Association Scientific Sessions, held in November in Philadelphia. Science shared at these two major cardiology conferences included:
- ACC 2019: Use of Guideline-Directed Medical Therapies for Comorbidities May Improve Outcomes for Patients with Atrial Fibrillation
- ACC 2019: Some Heart Disease, AF Patients on Combined Therapies Could Skip Aspirin
- ACC 2019: Compound Improves Heart Failure Biomarker Even After Hospitalization
- ACC 2019: Heart Failure Patients Not Having Medication Doses Increased to Recommended Targets
- ACC 2019: A Multidisciplinary Approach to Improve Care for Geriatric Heart Failure Patients
- AHA 2019: DCRI Study Tests Apixaban versus Warfarin in New Patient Population
- AHA 2019: Data Highlight Differences in Discrimination of Noninvasive CAD Testing
- AHA 2019: Stent Thrombosis is Rare but Serious in Patients with AF and Recent PCI
In addition to ACC and AHA, our cardiology faculty, fellows, and staff attended and presented at several other key cardiology related conferences throughout the year, including: the Cardiovascular Clinical Trialists Forum; European Society of Cardiology Congress; the 23rd annual meeting of the Heart Failure Society of America; the Society for Cardiovascular Angiography & Interventions Scientific Sessions; and the Transcatheter Cardiovascular Therapeutics Symposium.
Our conference attendance isn’t reserved for our cardiovascular therapeutics team only, however. DCRI faculty and operational staff also attended and presented at: The American Association for the Study of Liver Diseases; Digestive Disease Week; the Infectious Diseases Society’s IDWeek; the American Society of Nephrology’s Kidney Week; the American Urological Association’s 2019 Annual Meeting; the American Medical Informatics Association’s Informatics Summit and its Annual Symposium; the professional society for health economics and outcomes research (HEOR) annual ISPOR conference; the Society for Clinical Data Management’s SCDM 2019 conference; the Pediatric Academy Societies Meeting; the American Thoracic Society’s International Conference; and the International Stroke Conference.