Assessment of registration quality of trials sponsored by China

J Evid Based Med. 2009 Feb;2(1):8-18. doi: 10.1111/j.1756-5391.2009.01007.x.


Objective: To evaluate the quality of the registration information for trials sponsored by China registered in the WHO primary registries or other registries that meet the requirements of the International Committee of Medical Journal Editors (ICMJE).

Methods: We assessed the registration information for trials registered in the 9 WHO primary registries and one other registry that met the requirements of ICJME as of 15 October 2008. We analyzed the trial registration data set in each registry and assessed the registration quality against the WHO Trial Registration Data Set (TRDS). We also evaluated the quality of the information in the Source(s) of Monetary or Material Support section, using a specially prepared scale.

Results: The entries in four registries met the 20 items of the WHO TRDS. These were the Chinese Clinical Trial Registration Center (ChiCR), Australian New Zealand Clinical Trials Registry (NZCTR), Clinical Trials Registry - India (CTRI), and Sri Lanka Clinical Trials Registry (SLCTR). Registration quality varied among the different registries. For example, using the Scale of TRDS, the NZCTR scored a median of 19 points, ChiCTR (median = 18 points), (median = 17 points), and Clinical (median = 12 points). The data on monetary or material support for ChiCTR and were relatively complete and the score on our Scale for the Completeness of Funding Registration Quality ranged from ChiCTR (median = 7 points), (median = 6 points), NZCTR (median = 3 points) to (median = 2 points).

Conclusion: Further improvements are needed in both the quantity and quality of trial registration. This could be achieved by full completion of the 20 items of the WHO TRDS. Future research should assess ways to ensure the quality and scope of research registration and the role of mandatory registration of funded research.

MeSH terms

  • China
  • Clinical Trials as Topic*
  • Humans
  • Patient Selection*
  • Quality Control*