Denmark Finds Sponsors ‘Overburdening’ Study Sites To Support Decentralized Trials
Inspections, Scientific Advice Procedures Reveal Multiple Challenges
Executive Summary
A senior Danish GCP Inspector highlights instances of clinical trial sites facing burdensome procedures to support decentralized trials and discusses other challenges posed by such studies.
You may also be interested in...
EU Countries Focus On National Best Practices For Decentralized Trial Approvals & Inspections
The EU recommendation paper on decentralized clinical trials (DCTs) marked an important “first step” on the direction the European regulatory network wants to take with DCTs. Member states are now focused on reviewing and tracking DCTs to gain experience before considering the need for any updates to the recommendation paper.
Decentralized Trial Technologies An ‘Encumbrance’ For Site Personnel, US Survey Shows
The Association of Clinical Research Professionals says the perspective of personnel working at clinical research sites must be taken into account to ensure the effective implementation of decentralized clinical trials.
Decentralized Trial Approaches: How Do They Match Up To Conventional Studies?
Mira Zuidgeest is the principal investigator of a key EU study that proposes to compare fully remote, hybrid and conventional clinical trial approaches. She talks to the Pink Sheet about how the study might help understand “where we're heading with decentralized clinical trials.”