The clinical research industry is falling behind the innovation curve, says Ken Getz, executive director of the Tufts Center for the Study of Drug Development (CSDD), taking years — and sometimes decades — to evaluate, adopt and fully implement new technologies and methods. Read More
The University of North Carolina at Chapel Hill (UNC) School of Medicine’s innovative web-based solution to managing their trials’ startup processes was crowned the winner of this year’s Innovation Challenge at the 2023 MAGI East Clinical Research Conference in Philadelphia. Read More
Great progress has been made in the movement to improve diversity, equity and inclusion (DE&I) in clinical research, but experts say more work is needed improving trust and scaling down to the community level to continue making strides. Read More
Sponsors should build risk-based quality management (RBQM) into their trials as if they were constructing a house from the basement up, advises the director of the FDA’s Office of Bioresearch Monitoring Operations. Read More
Sites venturing into the growing field of digital therapeutics (DTx) need the appropriate infrastructure, tech know-how and adaptability, while sponsors need to be willing to offer training/support, iron out hurdles that come with remote components and simplify these trials whenever possible, a clinical research expert advises. Read More
DALLAS — With the clinical research workforce dwindling, it’s never been more important for sites and sponsors to “sell” themselves to job candidates, according to one talent acquisition expert who advocates knowing your organization’s true value. Read More
A long-awaited FDA draft guidance released last week clarifies the agency’s position on the design, planning and conduct of decentralized trials (DCT) but is notably silent on the question of responsibility for oversight of home health visits, a key issue for sites and sponsors. Read More
The pharma industry needs to come to a consensus on best practices for systematically evaluating the benefits and risks of drug products, says a new paper from AstraZeneca that aims to stimulate discussion on optimal ways to carry out benefit-risk assessments. Read More
Best practices for avoiding trial startup delays are available in a new publication from the Association of American Cancer Institutes (AACI) that offers a process map intended to improve alignment between sites, sponsors and CROs on study startup expectations. Read More
Expert certified good clinical practice (GCP) training will be available at the WCG MAGI Clinical Research Conference in Philadelphia next month. Read More