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.
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.
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.
ObjectiveTo construct a framework and functional items of a scientific research assistant tool for conducting systematic review for patient-reported outcome measures. MethodsBased on the research foundation and work experience of the system evaluation of two patient-reported outcome measures systematic reviews carried out by the research group in the early stage, the framework and function system of scientific research aid tool was initially constructed, and two rounds of correspondence were carried out by Dephi expert consultation method. ResultsThe effective recovery rates of the two rounds of expert consultation questionnaires were 90% and 100%, the expert authority coefficient was 0.839, and the compatibility coefficients of suitability and importance were 0.105 and 0.177, respectively. The final the patient-reported outcome measures tool system evaluation scientific research aid tool system consists of 7 frames and 31 items. ConclusionThis study has developed a scientific and comprehensive set of functional criteria for research-assistant tools that systematically review patient-reported outcome measures based on the COSMIN methodology and it lays the foundation for subsequent tool research and development.