Millennial Expectations Poised to Upend Clinical Trial Recruitment

Members of the largest demographic group in American history have been online since early childhood, probably don’t have a primary care physician, and pretty much expect their healthcare to be delivered how and when they want. Whether it’s via telehealth, using mobile apps, or other technologies, today’s so-called Millennials or Generation Y children—born roughly between […]

Thought Leaders Offer Rosy View on Future of Clinical Trials

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 […]

Gottlieb Says Real-World Evidence is Here to Stay

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 […]

GAO Report: Drug Companies Making Progress Expanding Drug Availability Beyond Trials

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 […]

Ensure Everyone’s On Board Before Launching eTMF Program

More than four years and hundreds of clinical trials later, Eli Lilly’s Nicole Sheetz is an even bigger believer than before in the power of electronic trial master files (eTMFs) to improve study transparency, oversight, and quality—but cautions others about the importance of addressing and changing any holdover “mindset” that fails to immediately recognize the […]