Article type
Year
Abstract
Background: previous studies have shown that most Chinese-sponsored drug-related randomized controlled trials (CS-D-RCTs) were positive, and the reporting quality was low. However, none of the studies was representative or comprehensive.
Objectives: to:
1) estimate the number of published CS-D-RCTs by language (Chinese and English) and by publication year (2006 and 2016);
2) describe the characteristics of published CS-D-RCTs; and
3) compare the percentage of positive CS-D-RCTs across language (Chinese and English) and publication year (2006 and 2016).
Methods: this was a cross-sectional study based on published literature. We searched seven bibliographic databases for CS-D-RCTs published as journal articles in 2006 or 2016, including three English bibliographic databases (EBDs) and four Chinese bibliographic databases (CBDs).
We classified CS-D-RCTs in five categories:
1) CS-D-RCTs published in Chinese and only indexed in CBDs;
2) CS-D-RCTs published in Chinese and indexed in both EBDs and CBDs;
3) CS-D-RCTs published in English and only indexed in EBDs;
4) CS-D-RCTs published in English and indexed both in EBDs and CBDs;
5) CS-D-RCTs published in English and only indexed in CBDs.
We counted the CS-D-RCTs in Categories 2,3,4, and 5. For CS-D-RCTs in Category 1, we randomly selected a portion of Chinese journals including CS-D-RCTs to reach a prespecified precision, then enumerated the CS-D-RCTs in selected journals.
We followed a standard screening process adopted in systematic reviews. We extracted the following information from the articles:
1) general information, including the name of the journal, publication date, registration status, funding source, etc;
2) design, including the randomization method, allocation concealment, masking method, whether intention-to-treat (ITT) analysis was conducted, whether sample size calculation was conducted, etc;
3) participants, including the sex, age, disease condition, sample size, etc;
4) interventions, including the name of the drug, comparison, follow-up period, etc;
5) outcomes, including whether primary outcomes were defined, and positivity of each primary outcome, etc.
We compared the number and characteristics of the CS-D-RCTs by language, indexed databases, and publication year.
Results: the number of total CS-D-RCTs has increased from 16,000 in 2006 to 44,000 in 2016. However, the percentage of the CS-D-RCTs published in English has decreased from 1.6% in 2006 to 1.4% in 2016. Information extraction is still ongoing. We expect the study will be completed by the end of August 2019.
Conclusions: the number of CS-D-RCTs has increased rapidly in the past decade covering a wide range of diseases and interventions. Although the absolute number has increased, the percentage of CS-D-RCTs published in English has decreased slightly.
No patient or healthcare consumer was involved.
Objectives: to:
1) estimate the number of published CS-D-RCTs by language (Chinese and English) and by publication year (2006 and 2016);
2) describe the characteristics of published CS-D-RCTs; and
3) compare the percentage of positive CS-D-RCTs across language (Chinese and English) and publication year (2006 and 2016).
Methods: this was a cross-sectional study based on published literature. We searched seven bibliographic databases for CS-D-RCTs published as journal articles in 2006 or 2016, including three English bibliographic databases (EBDs) and four Chinese bibliographic databases (CBDs).
We classified CS-D-RCTs in five categories:
1) CS-D-RCTs published in Chinese and only indexed in CBDs;
2) CS-D-RCTs published in Chinese and indexed in both EBDs and CBDs;
3) CS-D-RCTs published in English and only indexed in EBDs;
4) CS-D-RCTs published in English and indexed both in EBDs and CBDs;
5) CS-D-RCTs published in English and only indexed in CBDs.
We counted the CS-D-RCTs in Categories 2,3,4, and 5. For CS-D-RCTs in Category 1, we randomly selected a portion of Chinese journals including CS-D-RCTs to reach a prespecified precision, then enumerated the CS-D-RCTs in selected journals.
We followed a standard screening process adopted in systematic reviews. We extracted the following information from the articles:
1) general information, including the name of the journal, publication date, registration status, funding source, etc;
2) design, including the randomization method, allocation concealment, masking method, whether intention-to-treat (ITT) analysis was conducted, whether sample size calculation was conducted, etc;
3) participants, including the sex, age, disease condition, sample size, etc;
4) interventions, including the name of the drug, comparison, follow-up period, etc;
5) outcomes, including whether primary outcomes were defined, and positivity of each primary outcome, etc.
We compared the number and characteristics of the CS-D-RCTs by language, indexed databases, and publication year.
Results: the number of total CS-D-RCTs has increased from 16,000 in 2006 to 44,000 in 2016. However, the percentage of the CS-D-RCTs published in English has decreased from 1.6% in 2006 to 1.4% in 2016. Information extraction is still ongoing. We expect the study will be completed by the end of August 2019.
Conclusions: the number of CS-D-RCTs has increased rapidly in the past decade covering a wide range of diseases and interventions. Although the absolute number has increased, the percentage of CS-D-RCTs published in English has decreased slightly.
No patient or healthcare consumer was involved.