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ISSN 1001-5256 (Print)
ISSN 2097-3497 (Online)
CN 22-1108/R
Issue 12
Dec.  2018
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Article Contents

Important issues in protocol design of exploratory and confirmatory clinical trials of new drugs for nonalcoholic steatohepatitis

DOI: 10.3969/j.issn.1001-5256.2018.12.005
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  • Published Date: 2018-12-20
  • The research and development of new drugs for nonalcoholic steatohepatitis (NASH) is a research hotspot in the field of liver diseases. Confirmatory clinical trials are the key clinical trials for new drug registration, while exploratory clinical trials usually provide a basis for confirmatory clinical trials. Due to different objectives of clinical trials in different phases, there are different requirements and strategies for protocol design. Trial design should take into account both ethics and scientificity. Good protocol design needs to consider the methodology of clinical trials, the overall strategy for drug research and development, new drugs under research and their target indications, and clinical epidemiology, diagnosis, and evaluation of NASH.

     

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