Article

Pulmonology Division Launches New Volunteer-Based Health Data Repository

Leaders say the data will improve research, benefit patients

Clinical volunteer

Working to expand volunteer-based research and patient health data for investigators, a Duke pulmonologist has launched the first volunteer data repository for the Division of Pulmonary, Allergy, and Critical Care Medicine.

Loretta G. Que, MD, director of the Pulmonary Clinical Research Unit, leads the effort that began in September 2019 with recruitment of patients in the Duke Asthma, Allergy, and Airway Center. Que coordinates the division’s participation in clinical trials sponsored by industry as well as the National Institutes of Health.

“Our data is only as good as the number of patients we enroll,” Que says. “This is an important step in creating the research that helps us better understand disease mechanisms and find optimum therapies for the patients.” Previously, most investigators worked alone to recruit patients for specific projects.

The repository is part of the division’s effort to bolster research infrastructure, says Patty J. Lee, MD, the new chief of the division. Historically, less than 5% of adult patients at Duke volunteer for clinical trials—a participation rate that is below that of most academic medical centers, Que says.

Que’s team works to increase recruitment and awareness among the clinical staff while creating two data sets: one for healthy volunteers and a second for patients with a history of lung disease, which is defined broadly to increase participation. Que recruited Antoinette Santoro, MS, from the Duke Department of Anesthesiology to direct recruitment and manage the databases. “We need a more aggressive, more enlightened approach to encourage patient volunteer involvement,” Que says.

The model for the volunteer data repository was based on the new American Lung Association-Airway Clinical Research Center Lung Health Cohort that will be operational in 19 medical centers. “Our approach was enthusiastically received by the American Lung Association,” Que says.

In addition to improving research participation, data repositories offer benefits to potential patients that are enrolled in studies:

  • Access to physician visits with regional/national disease expertise at no cost to the study subject.
  • Access to studies that use new therapeutic approaches that may not be FDA approved.
  • Access to new investigational drugs, devices, and novel technologies
  • Participation in clinical studies that can improve understanding of health and disease.