Pediatric Trials Network studies lead to FDA approval of acyclovir labeling supplement
Research conducted by the Pediatric Trials Network (PTN) has led the U.S. Food and Drug Administration (FDA) to update the prescribing information, or drug label, of acyclovir to include dosing for infants with Neonatal Herpes Simplex Virus (HSV). The DCRI has acted as the coordinating center for the PTN since 2010 when it received its original funding from the National Institutes of Health (NIH).
Patient-generated data come with opportunities, challenges
With new wearable devices and apps entering the market every day, many clinicians have seen a proliferation of patient-generated data.
Gene therapy trial for Pompe disease begins
Actus Therapeutics, a privately held portfolio company of Asklepios BioPharmaceutical, Inc. (AskBio), recently announced the dosing of the first patient in a phase I/II clinical study of ACTUS-101 in patients with Pompe disease. Pompe disease is a serious disease associated with high morbidity and often leads to premature death. There are variable rates of disease progression and different ages of onset characterized as infantile-onset and late-onset disease.
Blood test for specific metabolites could reveal blocked arteries
Researchers hope to develop a test that could detect early changes in blood flow to the heart.
Interhospital transfer linked to treatment delays, worse outcomes in stroke patients
Patients who were moved between hospitals before receiving endovascular therapy were more likely to experience adverse clinical outcomes.
PRECISE begins enrollment, looks to improve CT intervention
A DCRI team has begun enrollment for a clinical trial investigating the optimal evaluation strategies for people with symptoms of coronary artery disease. PRECISE, or Prospective Randomized Trial of the Optimal Evaluation of Cardiac Symptoms and Revascularization, will enroll 2,100 patients across 100 sites in the U.S, Canada, and Europe. The trial is led by the DCRI’s Pamela Douglas, MD.
The DCRI welcomes new faculty member
Jessilyn Dunn, PhD, is a faculty member in Duke’s Departments of Biomedical Engineering; Biostatistics and Bioinformatics.
The past, present, and future of IPF research at the DCRI
Little is known about the cause of idiopathic pulmonary fibrosis (IPF), a devastating disease that is characterized by progressive scarring of the lung tissue that affects a person’s ability to bre
TRANSFORM-HF team pioneers new type of clinical trial
Heart failure patients have a tendency to accumulate excess fluid in the body, which can lead to debilitating symptoms such as shortness of breath and swelling. Loop diuretic medication, aims to prevent accumulation of this fluid and is the cornerstone treatment for heart failure signs and symptoms. With more than six million Americans affected by heart failure, and about one million hospitalized every year, a new DCRI study called TRANSFORM-HF will directly compare two well-known diuretics – furosemide and torsemide – to determine which is the most effective.
The DCRI’s Sheng Luo on the benefit of biostatistics
DCRI biostatisticians play a key role in many of the organization’s projects.