The clinical research industry's paralyzing delays, millions of dollars wasted on dead ends, and resource inefficiencies are the result of faulty team mechanics, several experts say.
The U.S. Food and Drug Administration (FDA) wants clinical trial sites to prove their compliance with regulations through better documentation of corrective actions, an expert says.
Starting new clinical trial (CT) sites requires adequate staffing and equipment, proactive standard operating procedures (SOPs), and budgeting skills.
Clinical trial (CT) sites should have a basic list of standard operating procedures (SOPs) written and in place before research is initiated, an expert suggests.
In this study, 2,499 hiv-seronegative men or transgender females who have sex with men (MSM) were randomized to daily TDF/FTC vs. placebo in a multicenter, controlled trial with clinical sites in North America, Latin America, Thailand, and Africa.
Two cases were reported in this paper. the first case was a 52-year-old wildlife biologist who went deer hunting in Virginia in November 2008.
