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find Author "WU Yangfeng" 3 results
  • Application of evidence-based medicine in diagnosis and treatment of cardiovascular diseases

    This paper tried to address how to apply the relative concepts and methods of evidence-based medicine in clinical practice of cardiology, especially in diagnosis and treatment, with an aim to promote the cardiovascular evidence-based medicine in China.

    Release date:2016-08-25 03:17 Export PDF Favorites Scan
  • Impact of the COVID-19 epidemic on ongoing clinical trials and suggestions for countermeasures

    Coronavirus disease (COVID-19) is currently a world-wide major public health event. Since study sites of clinical trials are primarily at healthcare institutions and investigators are primarily clinicians, the epidemic inevitably has a huge impact on a large number of ongoing clinical trials. The proper implementation of clinical trials in key aspects and the quality of core data collection will greatly influence the validity of the final results. In this paper, we analyzed the potential impact of the outbreak of a new epidemic infectious diseases on the clinical trials from seven aspects, which involves the selection of study participants, randomization, blinding, implementation of intervention measures, follow-up of primary outcomes, safety monitoring and project management. Corresponding countermeasures were put forward.

    Release date:2020-09-21 04:26 Export PDF Favorites Scan
  • Comparison of drug clinical trials between China, the United States, Europe and Japan in terms of study type, design, and completion

    ObjectiveTo compare drug clinical trials between China, the United States, Europe and Japan in terms of study type, design, completion and results publication.MethodsWe randomly selected 190 clinical trials that were registered in ClinicalTrials.gov from 2009 to 2014, and followed up to December 31st, 2019. Comparisons were made for the type of sponsor, phase, design, and completion status by the sponsor’s country.ResultsAmong all included clinical trials, trials from the United States, Europe, Japan and China accounted for 50.5%, 34.2%, 9.0% and 6.3%, respectively. Among these trials, 71.1% had been completed and 69.5% disclosed results had been published publicly prior to the end of follow-up, and differences between countries were statistically significant (P<0.05). Two-thirds of the trials in China were phase Ⅲ/Ⅳ trials; in contrast, most of the clinical trials in the United States and Europe were phase Ⅰ/Ⅱ trials. The proportion of using double-blind, randomized controlled trial design was the highest in the United States (46.9%) and the lowest in China (8.3%). Chinese sponsors were mostly hospitals/universities (58.3%), while in other countries drug trials were mostly sponsored by the industry and in Japan the proportion was as high as 94.0%.ConclusionsThe number of drug trials registered in ClinicalTrials.gov from China is small and these trials are less likely to be completed and have results published/disclosed. Pharmaceutical companies in China should pay more attention to the public registration of their clinical trials, particularly those in early phases, and improve trial design and management.

    Release date:2021-07-22 06:20 Export PDF Favorites Scan
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