The company plans in October to conduct a separate test specifically to study the seasonal flu vaccine's effectiveness among 480 elderly participants (a demographic often encouraged to get seasonal flu shots), and Phase III
efficacy trials across a larger set of demographics are scheduled to begin early next year.
Not exact matches
Three studies presented at the American Epilepsy Society's 69th Annual Meeting in Philadelphia highlight emerging
efficacy and safety data of Epidiolex, a pharmaceutical liquid formulation of cannabidiol, which is currently undergoing U.S. Food and Drug Administration (FDA) authorized Phase 3 pivotal clinical
trials in the United States and
across the globe by GW Pharmaceuticals.
The documentation ranges
across the whole spectrum of drug development: Investigators» brochures provide information on all that is currently known about the medicine and so need periodic updating; accurate and concise protocols are required to ensure that
trials are performed effectively; clinical
trial reports (generally from phase II and III studies) present the information gathered from the
trials; higher level documents provide summaries of
efficacy and safety data from clinical
trial programmes; expert reports provide critical interpretation of the results; and response documents clarify any points that are not clear to the regulatory agencies or provide additional analyses or supporting data for any items of concern.
Along with our nonprofit partners, this program aims to collect, organize, and validate massive amounts of data generated by clinical
trials across our global
trial network sites in order to generate novel insights into biomarkers for safety and
efficacy, novel treatment strategies, and personalization of treatment regimens.