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 […]

Patient Engagement Goals Driving New Research Partnerships, Services

The quest for greater levels of patient engagement in clinical trials is surfacing as a clearly stated driver behind more and more new research partnerships and services being announced in recent months. Just this week, the contract research/commercial organization Syneos Health revealed a strategic partnership with data analytics company AiCure to “drive faster, smarter trials […]

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 partnership […]

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 […]

Evaluating the Role of the Regulatory Writer

Clinical Researcher—November 2019 (Volume 33, Issue 9) PEER REVIEWED Ridge Archer, MACPR; Mary Raber Johnson, PhD, RAC; Esther Chipps, PhD, RN, NEA-BC   Drug development is a billion-dollar industry featuring a variety of roles necessary to pursue the goal of product approval.{1} A crucial component within this process is well-developed, well-documented, and well-communicated study research […]