As cell and gene therapies continue to reshape treatment for complex and rare diseases, clinical research teams are navigating new operational realities. As these therapies advance, development strategies are also evolving to address new operational, regulatory, and evidence-generation challenges. Unlike many traditional therapies, cell and gene therapies may...
Decentralized Clinical Trials (DCTs) are not a novel concept but have gained prominence with advancements in digital technology and the increasing need for patient-centric approaches. The recent release of the FDA’s final guidance on DCTs in September 2024 marks a...
Infant formula is an essential food product that serves as the sole source of nutrition for many babies in North America and Europe during their first year of life, supporting health, growth, and development.1,2 More than a year since the...
Progress in advanced computational methods using modeling and simulation has been enabled by advancements in computing technologies and the rise of artificial intelligence and machine learning. This has opened new opportunities in pharmaceutical drug development, such as the ability to...
Traditionally, early-stage clinical trials focus on toxicity assessment and dose selection. Today, a growing number of Phase 1/2a trials are designed to draw inference about preliminary response rates due, in part, to the use of biomarkers and adaptive design approaches...
Cancer is one of the most scientifically complex and dynamic diseases. Even with significant advances in our understanding of the genetic and molecular mechanisms that lead to cancer, only 10 percent of approved oncology drugs demonstrate an overall survival benefit.1...
By utilizing accumulating data to modify the operating characteristics of an active trial in accordance with pre-specified rules, adaptive designs can make clinical trials more flexible, efficient, and informative than fixed-sample designs.1 Adaptive design approaches can be applied across all...
Despite advances in our understanding of the complex genetic, molecular, and immunological factors which lead to cancer, the success and likelihood of approval rates for oncology remain low. According to a recent study performed by the Biotechnology Innovation Organization (BIO),...
Phase I and II trials may have different overall goals (i.e., demonstrating safety vs. efficacy), but the two both struggle with a major challenge in oncology study design: finding the right dose. Luckily, decades of data and innovations have given...