Drug Designing: Open Access
Open Access

The challenge in the design and operation of late phase clinical trials

International Conference and Expo on Drug Discovery & Designing

August 11-13, 2015 Frankfurt, Germany

Seung Eun Choi

Scientific Tracks Abstracts: Drug Des

Abstract :

Phase III and Phase IV studies have been performed as one of regulation’s requirement often. More safeties and more efficacies
could be kept by clinical studies after FDA’s approval. The phase Ð�?II clinical trials include big number of subjects and need high
cost in comparison to phase �? and phase �?�?. In addition, they must meet need of ethics completely too. The value of phase IV studies
has been emphasized in terms of keeping safety and efficacy post approval. There are more types of studies in late clinical studies,
including observational studies, post marketing surveillance as well as phase IV trials/studies. There are challenges of designing the
late studies and operation of them in the practice. The practical challenges are introduced and the solutions which would be practiced
to keep the studies from damage in the field are shared.

Biography :

Seung Eun Choi has completed her MD from College of Medicine, Seoul National University, and Surgery Residency from Seoul National University Hospital. She
completed her Clinical Fellowship in Pediatric Surgery in Seoul National University Children Hospital. She has completed her PhD in Transplant Immunology as full-time
Researcher from Microbiology and Immunology Department in College of Medicine, Seoul National University. Previously, she did in-vivo experiment in immunology area
during 6 years and has worked in several healthcare companies.