Allison Trainor, MPH, CPH, CCRC, UF Health Cancer Center in Florida

IRBs Don’t Have to be the Enemy

The upswing in multisite studies is making coordination between sites and institutional review boards (IRBs) simultaneously more important and more challenging, says Allison Trainor, MPH, CPH, CCRC, a clinical research coordinator at UF Health Cancer Center in Florida. It’s all too common for a site to find itself in a classic Catch-22 where there are […]

FDA Logo

Industry Applauds Selection of Gottlieb to Helm FDA

After a search that reportedly included a number of twists and turns, President Donald Trump has nominated Dr. Scott Gottlieb to be the next U.S. Food and Drug Administration (FDA) Commissioner. Gottlieb, a cancer survivor, is clinical assistant professor at New York University and health information technology adviser for the U.S. Department of Health and […]

Guest Blogger Angela Roberts, Head of CRA Recruitment, CRAresources

Are You Reading Fraudulent Resumes?

Don’t you love it when a terrific clinical research associate (CRA) just falls out of the sky? That is what happened to me recently—an outstanding resume seemed to literally drop in my lap. This CRA had the perfect education, terrific experience with a reputable contract research organization, and a wonderfully diverse therapeutic listing. Was she […]

Mutual Respect Key to Successful Informed Consent Program

Informed consent is not just about documentation, says Erica Jonlin, a regulatory manager at the University of Washington. Done properly, it can improve the pool of patients and the overall reputation of clinical trials, she adds. It’s incumbent upon the person doing the informing to understand the study backward and forwards—that means without having to […]

Former FDA Commissioner Robert M. Califf, MD

Former FDA Commissioner Calls for Increased Clinical Trial Education

Even as the clinical research enterprise is poised for “transformational progress,” swifter advancements in clinical trials are hampered by wariness over technology, miscommunication between industry and regulators, and a lack of education, former U.S. Food and Drug Administration (FDA) Commissioner Robert M. Califf, MD, said during a Clinical Trials Transformation Initiative (CTTI) webinar on March […]