House Democrats Press for COVID-19 Clinical Trial Transparency

“Dire consequences could result if any eventual authorization or approval of a vaccine is influenced by political pressure and is not based on sound science,” three leading congressional Democrats wrote last week to nine pharmaceutical companies currently developing COVID-19 vaccines. The politicians are seeking further information about the companies’ research and development efforts, as […]

Leaders Confront Lack of Clinical Trial Patient Diversity

Clinical trial experts from across the entire industry ecosystem took on the vexing problem of underrepresentation of minority populations in clinical trials at a September 15 summit sponsored by the Association of Clinical Research Professionals (ACRP) and The Avoca Group. Evonne Lackey, CCRP, director of clinical research at the Swedish Cancer Institute, said the industry […]

Clinical Study Reports 101: Tips and Tricks for the Novice

Clinical Researcher—September 2020 (Volume 34, Issue 8) PEER REVIEWED Sheryl Stewart, MCR, CCRP   The tenets of Good Clinical Practice (GCP), promulgated by the International Council for Harmonization (ICH), require that investigator-initiated trials (IITs), especially those involving an Investigational New Drug application to the U.S. Food and Drug Administration (FDA), have the principal investigator (PI), […]