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Digestive Diseases and Sciences

, Volume 64, Issue 4, pp 1050–1057 | Cite as

Design and Endpoints of Clinical Trials, Current and Future

  • Morris ShermanEmail author
Review
  • 93 Downloads

Abstract

With the advent of several new systemic agents for the treatment of hepatocellular carcinoma and the prospect of more to come it is expected that many more clinical trials will be undertaken to establish the best treatment paradigm(s). In order to help develop the most efficient and most relevant clinical trials this review concentrates on endpoints that have been used in the past. Survival is the gold standard. None of the surrogate endpoints correspond completely with survival. In addition, alternative clinical trial designs are presented that may be more efficient than the usual phase I, II, and III clinical trial strategy that has been used in the past.

Keywords

Hepatocellular carcinoma Clinical trial design Clinical trial endpoints 

Notes

Compliance with ethical standards

Conflict of interest

The author declare that they have no conflict of interest.

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Copyright information

© Springer Science+Business Media, LLC, part of Springer Nature 2019

Authors and Affiliations

  1. 1.Toronto Center for Liver Diseases, Toronto General Hospital EN 9-227University Health NetworkTorontoCanada

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