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Non‐inferiority margins employed in clinical trials in Japan
Author(s) -
Gosho M.
Publication year - 2015
Publication title -
journal of clinical pharmacy and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.622
H-Index - 73
eISSN - 1365-2710
pISSN - 0269-4727
DOI - 10.1111/jcpt.12268
Subject(s) - medicine , clinical trial , margin (machine learning) , drug trial , drug , pharmacology , machine learning , computer science
Summary What is known and objective Determination of the non‐inferiority margin is one of the major and most difficult considerations when planning a non‐inferiority clinical trial. This article aims to list the non‐inferiority margins employed in recent clinical drug‐development trials in Japan. Methods We investigated non‐inferiority margins by reviewing new drug‐development dossiers for drugs approved between January 2010 and December 2012 in Japan. Results and discussion We identified 174 non‐inferiority trials, where the efficacy of the test drug was compared to that of a control drug. We have described 70 clinical endpoints and the corresponding non‐inferiority margins. In antidiabetes drug trials, a margin of 0·4% mean difference in haemoglobin A1c level was used most frequently. In trials for glaucoma and ocular hypertension, 1·5 mmHg mean difference in intra‐ocular pressure value was the commonest margin. A 10% margin of proportion difference was the most frequently chosen in trials of anti‐infection drugs. We have provided a short description of the methods used to determine the non‐inferiority margin. What is new and conclusion We report on the non‐inferiority margins used for a range of endpoints in recent drug‐development trials for a number of different diseases. We hope that the details would be helpful to those appraising, reporting or designing non‐inferiority trials.