Look at Millennials to Predict the Future of Clinical Research Culture

If you have the pleasure of knowing me in the professional world, or perhaps sitting through one of my lectures, you’re all too familiar with what I have to say about caring for your workforce, creating your culture, and, frankly, managing your management and leadership. It’s a “soap box” I have stood on for many […]

‘Lost’ Drug Trial Highlights Potential of Repurposed, Repositioned, and Rescued Compounds

With Australian specialty pharmaceutical company Race Oncology’s announcement last week that the first patient had been treated with the “lost” drug Bisantrene in a clinical trial for relapsed/refractory acute myeloid leukemia (AML) in Israel, other firms may be reevaluating the potential for similarly repurposed, repositioned, or rescued drugs to become breakthrough treatments against the odds. […]

Savvy Planning Key to Navigating Successful Multi-Site Trials

There’s no “silver bullet" or “holy grail” when it comes to juggling complex, multi-center clinical trials, says Samantha Sharpe, CCRP, Program Manager, Nationwide Children’s Hospital: Abigail Wexner Research Institute. “There’s no magic template, or one way to do this,” she says. Instead, it takes old-fashioned hard work and planning. Lots of it. “Planning is key […]

FDA Headquarters

Acting FDA Commissioner Affirms Importance of Curtailing Rising Clinical Trial Costs

Calling out clinical trials as the “most expensive part of drug discovery and development,” Acting U.S. Food and Drug Administration (FDA) Commissioner Dr. Ned Sharpless just told agency staff he’s committed to promoting the use of innovative trial design among other tools to improve efficiency and speed delivery of drugs and devices to market. “We […]

Medical Device Adverse Event Reporting Presents Daunting Challenges

Site personnel must be empowered to leverage critical thinking when developing and implementing adverse event (AE) reporting procedures in medical device studies, two leading experts say. It might sound like common sense, but it’s not always so self-evident, says Bradley Lieberman, manager of clinical monitoring services at IMARC. Device studies are often complex but lacking […]