Correlates of the Quality of Pharmaceutical Clinical Trials Paper in Taiwan

• Main Authors: Wei-Shun Chang, 張惟舜
• Other Authors: Chung-Yeh Deng
• Format: Others
• Language: zh-TW
• Published: 2016
• Online Access: http://ndltd.ncl.edu.tw/handle/54694042763366478355

碩士 === 國立陽明大學 === 公共衛生研究所 === 104 === Objective Consolidated standards of reporting trials is used to improve the quality of randomized clinical trials papers. This study will use the variables of the basic information published in randomized clinical trials papers and classify consolidated standards of reporting trials into four types from the latest 2010 version as index. To study factors associated with randomized clinical trials papers’ quality among Taiwan pharmaceutical randomized clinical trials literatures. Method Using research data from PubMed medical database, literatures on Taiwan pharmaceutical randomized clinical trials are collected, up to the date of April 30, 2015. The datas are then analyzed by descriptive statistics and inferential statistics. Result All collected literatures, it can be found that in comparison with published papers before 1997, 1997 to 2002 and 2002 to 2011, published papers after 2011 have a greater value in average number of four types’ checklist items. Funding information in papers which average checklist items values are higher than no funding information in papers. Through multiple linear regression analysis, the literature publication year after 2011 and funding in papers are significantly better in type1, type2 and total section on the quality of randomized clinical trial papers. Conclusion Literature publication year and funding will significantly affect the quality of randomized clinical trials papers. After the publication of the consolidated standards of reporting trials in 2010, papers published after 2011 and funding information in papers have more checklist items in four types. Publication year variable is statistical significance in all types and total section. This shows that CONSORT2010 statement is useful to improve the quality of randomized clinical trial papers.