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 […]
The lack of data is a major bottleneck for many kinds of research, and especially for the development of better medical treatments and drugs. These data are extremely sensitive and, understandably, people and companies alike are often unwilling to share their information with others. Researchers at the Finnish Center for Artificial Intelligence (FCAI) have […]
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 […]
“We take [compliance with ClinicalTrials.gov] 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, […]
