Happy New Year, and welcome to our first Quality Issue of 2025! It this edition, we spotlight some of the most important developments in clinical research and Risk-Based Quality Management (RBQM). 2025 is going to be an interesting year for RBQM. Our prediction is that there’s going to be an increased focus on Central Monitoring […]
The complexities of oncology drug development have long posed significant challenges, particularly in determining the optimal dose that balances therapeutic efficacy with patient safety. The FDA’s recent guidance on dose optimization1 represents a significant milestone in addressing these concerns by refining outdated dose-finding methodologies. This article explores how dose optimization can enhance both patient safety […]
Welcome to this month’s Quality Issue, where we spotlight some of the most important developments in clinical research and Risk-Based Quality Management (RBQM). From transformative FDA guidance to our upcoming virtual event, here’s what you need to know. FDA Draft Guidance Aims to Transform Clinical Trials by Integrating RCTs into Routine Practice The FDA has […]
The FDA has just released a draft guidance, “Integrating Randomized Controlled Trials for Drug and Biological Products Into Routine Clinical Practice Guidance for Industry” aimed at transforming how Randomized Controlled Trials (RCTs) for drug and biological products are conducted. If finalized, this move could reshape the clinical trial landscape by merging trials with routine healthcare […]
The U.S. Food and Drug Administration (FDA) has made a significant move to modernize clinical research with the release of its final Guidance for Conducting Clinical Trials with Decentralized Elements. Published this month, the guidance reflects the increasing adoption of decentralized clinical trials (DCTs), where activities like telehealth consultations, home-based care, and the involvement of […]
