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A long-awaited FDA draft guidance released last week clarifies the agency’s position on the design, planning and conduct of decentralized trials (DCT) but is notably silent on the question of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
Early gathering of patient feedback on trial technology platforms is critical to warding off potential problems during a trial. One WCG expert outlines a number of important factors to consider early in development to ensure trials employ technology with patients in mind.
Screening, initial appointment logistics and first visits are the most frustrating trial processes for site staff, according to a new study on the burdens of critical processes and decentralized trial (DCT) methodologies that interviewed a select group of CRCs about their perspectives. Read More
Electronic informed consent (eConsent) appears to be just as easy, if not easier, for patients to use and understand as traditional paper-based consenting and improves consent document completion, a recently published study has found. Experts say these findings should give sites greater confidence in taking on eConsent solutions. Read More
Protocol complexity continues to grow, the latest data show, as sponsors seek more — and more specific — data, resulting in slower trials and overburdened sites and raising a crucial question: How do sites and sponsors simplify trials without sacrificing scientific progress? Read More