FDA Logo

FDA Suggests Narrowing Cancer Clinical Trial Focus

Clinical development takes too long and costs too much because of the time spent spinning wheels between the start and end of phases of clinical trials, says an increasingly proactive U.S. Food and Drug Administration (FDA). According to FDA Commissioner Scott Gottlieb, MD, “Expansion of cohort trials can bring efficiency to drug development, potentially reducing […]

Denise Snyder, MS, RD, LDN, Associate Dean for Clinical Research at Duke

Competency Standards Key to Elevating Clinical Trial Profession

“Everybody's talking about clinical research in a different way today than they did 20 years ago,” says Denise Snyder, associate dean for clinical research at the Duke University School of Medicine, and a member of the Association of Clinical Research Professionals (ACRP) Workforce Innovation Steering Committee (WISC), a group dedicated to advancing competency standards in […]

Brodie Reynolds, Senior Talent Partner, R&D Staffing

Is the Lack of Career Paths Hindering Professional Advancement in Clinical Research?

Sometimes you’ve got to get outside a situation to gain a new perspective. When Brodie Reynolds, senior talent partner, Genentech, takes a look at the clinical trial career environment, he’s not crazy about some of what he sees. Prior to rejoining the clinical trial fold, Reynolds worked with American Express and Facebook, among other companies. Returning […]

Jim Nichols

Are You Ready to Meet FDA’s Strict eCTD Requirements?

The U.S. Food and Drug Administration (FDA) has given industry nearly three years to get ready to handle submission of the electronic common technical document (eCTD), so don’t expect much sympathy from the agency today if you don’t comply, says Jim Nichols, COO at Cunesoft. After a few delays, using an eCTD to file the […]

Unified Regulators Complicate Site Compliance Programs

The Medicines & Healthcare products Regulatory Agency (MHRA) in the U.K. and the U.S. Food and Drug Administration (FDA) are working more closely together in new ways to synchronize—and strengthen—each other’s regulatory inspections, according to an anecdotal data research report on trends in practices of these and similar regulatory authorities around the world from The […]