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Returning individual research results to clinical study participants has not historically been the norm, even for participants with abnormal findings. The paradigm, though, is shifting, with return of results becoming not only a scientific responsibility but also an ethical imperative. However, best practices haven’t been established yet. A team of Duke researchers led by Svati H. Shah, MD, MS, Ursula Geller Distinguished Professor of Research in Cardiovascular Diseases, and Neha Pagidipati, MD, MPH, associate professor of medicine, have developed a model using the Project Baseline Health Study (PBHS) for how to effectively communicate results to patients and help empower them towards their health and medical choices. The study also detailed the large number of abnormal results that were returned to participants, highlighting the need to consider these processes early in study design. Results were published in the American Journal of Medicine Open.

Five years after the start of the COVID-19 pandemic, the research community is reflecting on the historic research response to understand the disease and develop diagnostics, therapies, and vaccines. In a special thematic issue of the Journal of Clinical and Translational Science, a set of papers outlines the most critical takeaways for the public health and research communities that should be applied to future public health emergencies.

Leading experts recently explored how generative AI could revolutionize clinical research through automated documentation and enhanced trial efficiency. Their findings, published in JACC: Advances, outline crucial steps for successful AI integration while addressing technical, ethical, and regulatory challenges to ensure more accessible and effective research outcomes.

A study led by the Duke Clinical Research Institute (DCRI) in partnership with Vanderbilt University found no symptomatic or clinical benefit in taking metformin at a titrated dosage of 1,500 mg per day for 14 days for the treatment of mild-to-moderate COVID-19 symptoms.

A new publication developed in collaboration by CTTI, the Duke Clinical Research Institute (DCRI), the Duke Margolis Institute for Health Policy, and Protas published in Trials highlights the current barriers to clinical trial transformation, areas of improvement, and actions needed to transform clinical evidence generation in the United States to better align with clinical care demands. A modern clinical trial infrastructure should prioritize trial accessibility, answer relevant study questions reliably, respond to public health emergencies rapidly, and more.

New evidence and results from eight studies based on data from the IPF-PRO/ILD-PRO Registry was shared by the Duke Clinical Research Institute (DCRI) and its collaborators at the American Tho

After decades of decline, heart failure mortality is climbing, with a dramatic rise in heart failure deaths among younger adults. The number of people dying from heart failure in the United States went down steadily from 1999 to 2009. However, progress made in treating heart failure began unraveling from 2009 to 2012 when heart failure-related mortality rates plateaued, according to a study led by Duke University School of Medicine.

An antibiotic that has shown effectiveness for bacterial pneumonia also appears successful in fighting methicillin-resistant staph infections, reports a team led by Duke Health. The drug, ceftobiprole, showed similar benefit when tested against the antibiotic daptomycin to treat complicated Staphylococcus aureus bacterial infections. If approved by the FDA, ceftobiprole could provide another line of defense against a common and often deadly bacterial infection.

A study led by the Duke Clinical Research Institute (DCRI) in partnership with Vanderbilt University found no clinical benefit to taking fluticasone furoate for treatment of mild-to-moderate COVID-19 symptoms.

Despite numerical improvements in mortality, hospitalizations and exercise ability, data did not reach the pre-specified level of statistical significance.