Creating Novel Methods

As the world changes—including the emergence of new digital technologies, novel data sources, and even, in the case of the COVID-19 pandemic, never-before-seen diseases—the ways in which we conduct clinical research must also change.

As the world’s largest academic clinical research organization, the DCRI has long been at the forefront of developing and testing novel methods that can accelerate research timelines, better partner with patients, and answer more questions. Today, the DCRI is leading the way in use of novel methods and trial designs, such as virtual trials and master protocols, to answer questions more efficiently and improve health around the world—while creating a research process that truly works for patients and sites alike.

Innovate to Accelerate: Putting Novel Methods to the Test

From cutting-edge statistical methodologies to novel networks that enable research based on electronic health records, the DCRI leverages many innovative strategies to accelerate traditional research timelines—while still ensuring reliable and trusted data.

Statistical Innovation: Modeling to Big Data

Past and present members DCRI biostatisticians discuss the innovations that the Biostatistics team has brought to clinical research throughout the institute's history, from modeling techniques to analysis plans for new study designs.

Watch a video featuring Kerry Lee, PhD; Zhen Huang, MS; and Laine Thomas, PhD, talking about the evolution of DCRI’s biostatistics work.


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Discovering More Answers Through Open Science

The pioneering open science effort Supporting Open Access for Researchers (SOAR) paid homage to DCRI's history by making four decades' worth of data from the Duke Cath Lab publicly available for research and education—a first for a university health system.

Watch Frank Rockhold, PhD, talk about the promise of open science and how the DCRI facilitates it via SOAR.


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PCORnet: Enabling More Efficient Research

The DCRI serves as the coordinating center for PCORnet®, the National Patient-Centered Clinical Research Network, which aims to improve efficiency of health research nationwide. DCRI led the ADAPTABLE study, which demonstrated research enabled by electronic health records via PCORnet, and has embarked on additional novel studies leveraging the power of PCORnet.


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Listen to Jenny Cook, MPH, and Lauren Cohen, MA, discuss DCRI research enabled by PCORnet.

Finding Treatments Faster via Master Protocols

DCRI's clinician-researchers are developing studies using master protocols, also known as platform trials, in order to study multiple interventions concurrently and thus enable faster, more efficient research in many clinical areas, including COVID-19. Several factors contribute to DCRI's leadership in the master protocol space, including our range of clinical expertise, our ability to manage operational complexities, and our strong analytics capabilities.


Listen to Christoph Hornik, MD, PhD, MPH, talk about how the DCRI uses our expertise to lead master protocols.

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Accelerating Knowledge Through Partnerships

The DCRI relies on many ongoing partnerships in order to conduct innovative clinical research. One such partnership is with Verily Life Sciences LLC, an Alphabet company, which has enabled large-scale, real-world research such as the HERO research program and Project Baseline, which aims to use longitudinal, real-world data to learn more about health.


Listen to Beth Fraulo, RN, BSN, discuss unique aspects of DCRI’s partnership with Verily and the research it has enabled.


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Real-World Data for Real-World Questions

The DCRI responded to COVID-19 by creating the HERO Registry, which leveraged PCORnet® to better understand the pandemic's impacts on health care workers, and by co-creating the HERO-TOGETHER study, which tracks real-world safety data for the COVID-19 vaccines.


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Watch Emily O'Brien, PhD, give an overview of HERO. 

Engaged and Embedded: Making Research Frictionless for Patients

The DCRI believes that all people should be partners in research. We take the approach of creating bidirectional relationships in research, which is evidenced in the two examples below, in order to make studies more accessible and easier for patients to participate in. Data show that more engaged patients lead to more successful studies—ensuring that, ultimately, we find the answers that patients seek.

Co-Creating Research With Patient Partners

Renee Leverty, BSN, MA, program lead for DCRI Research Together, speaks with patient advocate Fredonia Williams, PhD, about her contributions to DCRI study CONNECT-HF as a patient partner after receiving a new diagnosis of heart failure.

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Virtual Trials Bring Research to Patients

DCRI pediatric rheumatologist Stephen Balevic, MD, speaks about DCRI’s partnership with the Childhood Arthritis & Research Alliance (CARRA) with Vincent Del Gaizo, a representative of CARRA. DCRI is leveraging CARRA to conduct a novel virtual trial.

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