With a new international guidance open for public comments, stakeholders in digital, hybrid, and fully decentralized clinical trials (DCTs) may feel a growing urgency to harmonize global regulations to prevent any roadblocks to adopting the technologies necessary to achieve the benefits of this approach.
This study explored the experiences of clinical research principal investigators (PIs) in addressing diversity in clinical trials. The PI respondents, recruited through social media and professional networks, shared their insights through interviews.
Digital medicine represents a paradigm change in oncology research by harnessing technological breakthroughs to address the constraints of traditional clinical trial procedures. Researchers may collect huge amounts of patient-generated health data by adding digital tools into the clinical trial process.
This article presents a fictionalized scenario and details to illustrate career options worth considering in contract research organizations and other settings.
Amidst discussions regarding quality control and software, it is crucial to remember the ultimate objective of this effort: the creation of a Registration Dossier ensuring that the data generated during the different stages of the lifecycle of the product are accurate, complete, and reliable.