Since the introduction of the original 3+3 method, the available design options for dose escalation in early phase studies have expanded beyond traditional algorithm-based designs to include model-based designs.
Oncology dose-escalation trials are a distinct entity, with nuances and considerations which set them apart from other therapeutic areas. From varying trial designs to the patients who participate, dose-finding clinical trials in oncology are a clinical research paradigm. Understanding strategies to facilitate success is key to study planning and execution, from feasibility to site selection through enrollment and treatment.
Clinical pharmacology is an important cornerstone of the clinical development of drugs, which this blog post has only begun to introduce. Future blog posts will focus on various aspects of clinical pharmacology, including the types of studies that comprise a clinical pharmacology program, a comparison of clinical pharmacology programs for large and small molecules, evaluations of drug interactions, and regulatory considerations for clinical pharmacology.
From the continuous development of clinical trial and data platforms to the ever-increasing complexity of therapeutic landscapes, understanding the best approach towards conducting feasibility for a clinical trial can prove daunting. Through our expertise in the most innovative feasibility tools and data platforms, we combine these data sources with our operational experience to put forth the most comprehensive, data-driven approaches to starting clinical studies off on the right foot.
While a 505(b)(2) NDA can potentially get a drug to market faster than a 505(b)(1) NDA, the choice of a bridging strategy to the listed drug is important and involves consideration of multiple factors.
