FDA Headquarters

FDA Officials Shower Investigators with Praise—And a Few Warnings

Leading U.S. Food and Drug Administration (FDA) officials hailed clinical study investigators as some of the unsung heroes of the clinical trial ecosystem during an agency training course last week in College Park, Md. However, regulators also reminded anyone contemplating leading studies to understand just how difficult the principal investigator (PI) role can be. “It’s […]

FDA Officials See Big Clinical Trial Changes on the Horizon

“My prediction is that clinical trials in 10 years’ time will be very hard for us to recognize,” Leonard Sacks, MD, associate director for clinical methodology in the Office of Medical Policy at the U.S. Food and Drug Administration’s (FDA’s) Center for Drug Evaluation and Research (CDER), told attendees of the agency’s Clinical Investigator Training […]

OhioHealth Research Institute Joins ACRP’s Clinical Research ‘Workforce Innovation Steering Committee’

The Association of Clinical Research Professionals (ACRP) welcomes OhioHealth Research Institute as the latest member of the ‘Workforce Innovation Steering Committee’ (WISC). The WISC is a collaborative partnership of private and public stakeholders working to improve clinical trial quality and respond to changes impacting the workforce by providing oversight for needed standardization activities. The […]

Cystic Fibrosis Clinical Research Coordinator Mentoring Program: A Review

Clinical Researcher—November 2019 (Volume 33, Issue 9) PEER REVIEWED Zoe Davies, NP, MS, CCRC; Colleen Dunn, MS, RRT, CCRC; Elizabeth Hartigan, MPH, RN, CRM; Kathleen Hilliard, CCRC; Patricia Burks, RN, MA, CCRC   Cystic fibrosis (CF) is an inherited, autosomal recessive, multisystem disease that affects approximately 30,000 individuals in the United States{1} and is caused […]