Unpacking the FDA’s New Guidance on Remote Data Acquisition
The FDA’s recently released guidance on Digital Health Technologies for Remote Data Acquisition in Clinical Investigations represents a significant step forward in the exploration and application of digital health tools. As someone who works with technology innovators, drug and device clinical trial sponsors, and the medical innovation investment community, I’m convinced that this guidance has arrived at an ideal time.
NIH Collaboratory Celebrates 10 Years of Rethinking Clinical Trials®, Changes Program Name to NIH Pragmatic Trials Collaboratory
The NIH Collaboratory launches into its tenth year with a new name, continued commitment, and enhanced web tools and resources.
With ‘Test-to-Stay,’ Children and Staff Can Safely Remain in School After COVID Exposures
Top scientists and physicians from the ABC Science Collaborative outline how a more focused COVID-19 “test-to-stay” protocol can keep kids in school without overwhelming the system.
Amgen Joins CardioHealth Alliance to Expedite Evidence-Based Solutions for Prevention and Care of Cardiovascular, Renal, and Cardio-metabolic Diseases
The CardioHealth Alliance welcomes Amgen as a new member and invites others to join in the effort to advance prevention and care.
Patient Survey Finds Post-operative Pain Common After Total Joint Replacement Surgery
A survey of 2,638 Duke Health patients who had total replacement of knee, hip, or shoulder joints in 2014-20 found that approximately one-third experienced high-impact or bothersome chronic pain fo
Lung Transplant Clinical Trials Network Renewed for Seven More Years
With $21 million in new funding from the NIAID, the network now includes eight centers in North America and will study adolescent lung transplant recipients as well as adult.
DCRI Think Tank Considers Promise of Machine Learning in Clinical Evidence Generation
Stakeholders at a January 2020 DCRI Think Tank examined the role of machine learning (ML) in the design, conduct, and analysis of clinical trials.
New Heart Clinical Trial to Shine Light on Early Atrial Fibrillation Treatment
Until now, scientific research about treatment for the most common type of heart arrythmia, atrial fibrillation (AFib), has primarily focused on patients with already established cases of the condition. CHANGE AFib, a new pragmatic clinical trial, will determine whether early treatment with the antiarrhythmic drug dronedarone improves cardiovascular and long-term outcomes in patients presenting to the hospital with first-detected AFib.
CSRC Pilot Project Creates Novel Pediatric ECG Data Warehouse
A new project led by the Cardiac Safety Research Consortium created a first-in-kind data warehouse to help ensure comprehensive cardiac safety review for therapeutic product development for children.
Data Finds Universal Masking Limits School Transmission of COVID-19 Despite Delta Variant
The ABC Science Collaborative’s latest study published in Pediatrics includes data from 20 school districts during summer 2021, when the Delta variant became the dominant strain of SARS-CoV-2 in th