In recent years, several nucleoside analogues have been authorized to treat patients with chronic hepatitis B. Evidence of efficacy and safety provided by clinical trials with these agents was adequate to back their licensing authorization. Without question, however, there is room to improve trial design if future pivotal trials are to provide more informative data than those derived from the trials of authorized nucleoside analogues. In response to a call to reexamine trial design for chronic hepatitis B, the author presents personal thoughts in hopes that data derived from future trials may provide more robust efficacy and safety evidence and, therefore, provide clinicians with informative instructions on the use of these drugs, which should be an important consideration in granting licensing authorization.
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