Characteristics of anticancer drug studies registered on the Chinese Clinical Trial Registry (ChiCTR) from 2007 to 2015

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Abstract

Objective:

This research aims to examine the basic and methodological characteristics of anticancer drug studies registered on the Chinese Clinical Trial Registry (ChiCTR) and explores the progress of implementation of good clinical practice (GCP) and the challenges it poses for anticancer drug research in China.

Methods:

The studies from 2007 to 2015 were downloaded from the ChiCTR and those involving anticancer drugs with evaluation of the main dimensions. The numerical trend of the studies registered each year was analyzed. Chi-square tests were performed to test for significant differences between different funding sources, types of drug and study phases.

Results:

Six hundred and four anticancer drug studies were collected. The overall number of anticancer drug studies was increased. Significant differences could be seen in the dimensions of multicentre study (P = 0.000), participant number (P = 0.029) and randomization procedure (P = 0.005) for the three funding sources. There were significant differences in the dimensions of multicentre study (P = 0.001), participant number (P = 0.025), collecting samples from participants (P = 0.006), and randomization procedure (P = 0.009) between different kinds of drugs. There were also significant differences in the dimension of participant number (P = 0.025) and randomization procedure (P = 0.016) between different study phases.

Conclusion:

There are problems with study registry criteria and study type classification method. Also, within the studies researched, heterogeneity exists for various dimensions. Different sources of funding, distinct types of drug and disparate phases of study lead to significant differences in certain dimensions of anticancer drug studies.

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