Chronic lung diseases affect millions of people around the world, making them a leading cause of death in both the U.S. and globally. These conditions lead to symptoms such as breathlessness, frequent hospitalizations, and impaired quality of life. Despite treatments currently available, many patients continue to experience a decline in respiratory function, increased disability, and premature death.
Conducting the necessary research to develop new treatments for respiratory diseases can be complex and challenging to execute. However, the DCRI Respiratory Medicine team is uniquely positioned to collaborate with foundations, federal agencies, and industry partners to support studies aimed at improving the health of patients with respiratory disease.
DCRI: An Academic Full Service CRO
The DCRI Respiratory Medicine team consists of practicing physicians who actively care for patients with lung diseases, innovative data scientists, and the operational resources of a full-service clinical research organization (CRO) – all embedded within Duke University. Collaborating with industry, foundation, and government partners, the DCRI forms project teams with deep subject matter expertise and practical experience conducting high-impact clinical and translational respiratory studies, from early to late phase trials, to registries, to real-world data analyses.
Disease Area Expertise
Our team provides clinical expertise across all areas of pulmonary, critical care, and sleep medicine, with particular strength and experience in the following areas:
- Chronic obstructive pulmonary disease (COPD)
- Idiopathic pulmonary fibrosis (IPF)
- Interstitial lung disease (ILD), including progressive pulmonary fibrosis (PPF)
- Asthma and airway biology
- Rare lung diseases
- Lung transplantation
Disease Spotlight
Interstitial Lung Disease (ILD)
ILD, including IPF and non-IPF PPF, is associated with poor prognosis and diminished quality of life despite the advent of antifibrotic treatments. The DCRI Respiratory Medicine team has significantly advanced our understanding of ILD by coordinating a variety of studies across all phases of clinical research:
- The IPF- and ILD-PRO registries have enrolled XXX patients across XXX centers. These registries address crucial knowledge gaps related to approved therapies in clinical practice, lung function and quality of life outcomes, and potential biomarkers for disease progression. Visit the IPF-PRO website
- Phase II and III clinical trials have evaluated the efficacy of potential new therapies in collaboration with industry and government partners, while incorporating both traditional and innovative pragmatic trial designs.
- Innovative analyses of trial and electronic health record (EHR) datasets have helped to define the utility of synthetic control groups as a strategy to improve the efficiency of future clinical trials for IPF and other ILDs.
- Collaboration between PCORnet partner site networks and our innovative data scientists has facilitated analyses that clarify the characteristics of real-world ILD and PPF populations and assess the risk of disease progression using EHR data.
Innovative in Action
Click the headers below to explore examples of previous and ongoing studies that illustrate the breadth of the DCRI’s novel approach to disease areas, study types, and methodological innovations.
OBERON: phase III, biologic agent, employed EHR-based computable phenotype to augment recruitment/enrollment
Utilizing predictive data analytics for managing COPD exacerbations, this digital inhaler technology monitors inspiratory flow during inhaler use, using flow data to create a model that can predict exacerbations.
Can we include Sanofi registry, or too early/contract not finalized?
- IPF- and ILD-PRO
- BMS phase 2 study
- I need an example here
Lung Transplant Consortium (LTC): The DCRI serves as the data coordinating center for a network of 20 transplant centers, providing a platform for observational research and biomarker analyses. LINK TO WEBSITE.
Can we include your Rezurock study Scott?
If not, maybe include Valgan in spite of it being awhile ago now, as it remains a good example of an RCT completed in a challenging disease area
Site Network & Partners
Our network consists of over XXX sites across the United States, including academic and community-based clinical research centers, providing the ability to tailor site selection to a specific disease area and/or study type. Additionally, through established partnerships with other CROs, we offer flexible options for conducting studies on a global scale.
Meet the DCRI Respiratory Medicine Team
Faculty Leadership
The DCRI Respiratory Medicine faculty have published over 500 peer-reviewed manuscripts in the field of respiratory diseases and holds key roles in professional societies, guideline committees, and on the editorial boards of leading respiratory journals. As a result, the DCRI is equipped to provide in-house key opinion leadership for studies covering a wide variety of respiratory conditions.
In collaboration with our cutting-edge data science faculty and comprehensive operational capabilities, our team is uniquely positioned to offer end-to-end guidance, from study conception to completion, ensuring that your study is conducted efficiently and achieves maximum scientific impact.
