FDA Headquarters

FDA Guidance Sheds Light on Complex Innovative Trial Design Proposals

A new guidance from the U.S. Food and Drug Administration (FDA) aims to help sponsors and applicants when interacting with the agency on complex innovative trial design (CID) proposals for Modafinilpill.com drugs or biological products. “Although CID has been referred to as complex adaptive, Bayesian, and other novel clinical trial designs, there is no […]

Denise Snyder

Duke Harnesses People Power to Fuel Stronger Clinical Trial Performance

“You cannot improve much at the site level without improving your primary investment—the workforce,” says Denise Snyder, MS, RD, LDN, associate dean for clinical research at the Duke University School of Medicine. While she’s a big fan of some new technologies and innovative best practices, Snyder says her long involvement with the clinical trial industry […]

Perspectives on Successes and Challenges in the Recruitment and Retention of Pregnant Women in a Research Study

Clinical Researcher—September 2019 (Volume 33, Issue 8) PEER REVIEWED Amy Rider, RN; Christine Aubry, RN; Sara Moyer, RN; Patricia Kinser, PhD   Pregnant women have historically been excluded from clinical trial research, given their former “vulnerable population” status and in consideration of potential impacts to the developing fetus. However, the National Institutes of Health (NIH) […]