Dystopian science fiction stories like Blade Runner and The Terminator make for exciting and popular, if depressing, viewing. By contrast, “happy” stories aren’t as compelling when it comes to drawing a big audience to a movie theatre. Luckily, the folks contacted by PA Consulting offered up some pretty rosy predictions for the clinical trial world […]

Unlike some other buzzwords and shiny tools, the concept of leveraging real-world evidence (RWE) in clinical trials isn’t going anywhere. At least that’s the assessment of big RWE fan and former U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb, MD. RWE is here to stay, Gottlieb says, in part because Congress has finally put […]

Drug manufacturers are reporting positive strides in terms of increasing access to investigational drugs outside clinical trials, according to a Government Accounting Office (GAO) report issued Monday (September 9). Of the 29 manufacturers interviewed, 23 posted their expanded access policies on their websites; four said they wouldn’t consider expanded access requests. The U.S. Food and […]