OBJECTIVES: In view of the publication of the draft ‘Chinese Guidelines for the Application of Patient-reported Outcomes in Drug Clinical Research’ (December, 2021) we examined the availability of clinical outcomes assessment (COA) instruments in Chinese language. We explored therapeutic areas where the use of COA was well established (oncology, endocrine metabolism, rheumatology, dermatology, gastroenterology, and neurology) and checked for the availability of COAs translated into traditional or simplified Chinese as well as Mandarin or Cantonese dialects.

METHODS: Translations available for each disease area were searched in the ePROVIDE database. The age group for selected COA instruments was adult population (18+). Only those COA instruments that had existing translations in Chinese (traditional or simplified, Mandarin or Cantonese dialects) were included in the final sample.

RESULTS: A total of 60 instruments were identified in the pre-specified disease areas. The largest number of available COAs translated into Chinese language were found in the following disease areas: endocrine metabolism (n=22), rheumatology (n=13), followed by dermatology (n=10), oncology (n=7), gastroenterology (n=5) and neurology (n=3). The vast majority of identified COAs were patient reported outcome measures.

CONCLUSIONS: Several COA instruments are available for the Chinese market already, but further use in drug development and suitability for Chinese regulatory opinion is still to be determined. Most instruments have been developed into traditional or simplified Chinese, rather than Chinese dialects spoken in specific regions. The availability of validated translations of COAs in Chinese language will allow sponsors to expand their clinical investigations to this region, making new treatments more accessible to Chinese patient populations.