Two Questions and Five Suggestions Before You Begin Implementing Decentralized Trials

Contributed by Joy Jurnack, RN, CCRC, FACRP Our industry is hyper-focused on patient centricity, but how is the philosophy implied by this term implemented in a practical way? This question has been front and center in my mind since switching my perspective from site operations to engagement and solutions for patient-centric research. Simply put, arriving […]

DSMB Reports How it Monitored the COVID-19 Vaccine Trials

Clinical evaluation of three COVID-19 vaccine candidates in 2020 and 2021 during a worldwide pandemic that killed or sickened millions was unprecedented in terms of urgency and scope. Responsibility for the safety, integrity, and scientific validity of the trials in the United States fell to 12 experts of the federally appointed COVID-19 Vaccine Data and […]

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NIH All of Us Program Marks Diversity Milestones

The All of Us Research Program at the National Institutes of Health (NIH) has made significant progress since its national launch three years ago, building and providing unprecedented access to a vast and diverse health research databank, reports Andrea H. Ramirez, MD, MS, All of Us senior advisor, and colleagues in the Journal of the […]

FDA Letter Signals Seriousness of Submitting Results to

“We take [compliance with] requirements seriously,” says Miah Jung, PharmD, a pharmacologist with the U.S. Food and Drug Administration (FDA). While the FDA “hopes for voluntary compliance,” the agency also wants regulated entities to understand the importance of compliance and the potential consequences of failing to meet regulatory expectations, adds Jan Hewett, BSN, JD, […]