Designing Studies to Evaluate Anti-Hepatitis B Virus Therapies: From the Perspective of Studies for the Registration of Pharmaceutical Products

The clinical studies that are required to obtain world-wide regulatory approval to market therapies for the treatment of hepatitis B virus (HBV) are lengthy, large, and costly. It is therefore important that those undertaking such studies fully understand the disease, the current therapies available, the requirements of major regulatory authorities, and the role that the new therapy will play in the treatment of the disease before embarking on these studies. The aims of this chapter are to outline some of the factors that should be taken into consideration when planning such studies, to highlight common pitfalls in the design and conduct of these studies, and to provide some suggestions on how these pitfalls might be avoided.