Science 37 is excited to be part of the first-of-its-kind direct-to-family study with the Duke Clinical Research Institute (DCRI) for decentralized research in pediatric lupus. The iPERSONAL (Individual Patient Exposure and Response in Pediatric Lupus) study will help determine the most effective dose of hydroxychloroquine for children and teens with lupus as well as whether a digital pill bottle aids medication adherence. As the world continues to adapt to the global COVID-19 pandemic, the study will demonstrate that a decentralized trial model can make it easier for children and their families to participate in groundbreaking research from home.
DCRI Launches First Direct-to-Family Study to Improve Medication Dosing and Adherence in Children and Teens with Lupus
Home-based clinical study design combines on-site nursing visits and mobile technology to embed research into patients’ lives
DURHAM, N.C. (Sept. 16, 2020) – The Duke Clinical Research Institute (DCRI) today launched the first direct-to-family, decentralized clinical trial to help determine the most effective dose of hydroxychloroquine, commonly known as Plaquenil®, for children and teens with lupus. The iPERSONAL (Individual Patient Exposure and Response in Pediatric Lupus) study also will test whether a digital pill bottle will help children and teens remember to take their medicine.
“Not only does this study use an exciting new model of clinical research, but it is also answering important questions for pediatric patients with lupus,” said Stephen J. Balevic, MD, MHS, Assistant Professor of Pediatric Rheumatology at Duke University and co-principal investigator for the study alongside Christoph Hornik, MD, PhD, MPH, Associate Professor of Pediatrics at Duke University. “Although hydroxychloroquine is the most commonly prescribed drug to patients with lupus, it has never been studied in children to understand the optimal dose needed to reduce lupus disease activity. By conducting this study using a digital pill bottle cap, we’re also studying new ways to improve medication adherence, which is often a challenge when patients experience onset of lupus during childhood and adolescence.”
The DCRI is working with Science 37, the industry leader in decentralized clinical trials, to provide the clinical trial platform and mobile research team needed to conduct the study directly in participants’ homes. Virtual studies, like iPERSONAL, have become an increasingly important way to conduct research during the COVID-19 pandemic, and all precautions will be taken to safely conduct the study.
“The Science 37-DCRI collaboration highlights how meaningful the integration of technology and decentralized clinical trial operational expertise can be in designing and executing clinical research focused on the patient experience,” said Jonathan Cotliar, MD, Chief Medical Officer at Science 37. “The iPERSONAL study helps to demonstrate patient safety and high-quality data while we make it easier for children and their families to participate in groundbreaking research from home.”