ABSTRACT
With the spread of the new coronavirus pneumonia in China, medical researchers at home and abroad have carried out clinical studies in order to find the best way to combat the epidemic. The quality control measures are the key to ensure the scientificity of results. An overview of a multi-center randomized controlled double-blind clinical study was presented which was on the efficacy and safety of terazavirin in the treatment of COVID-19. It has pointed out that the difficulty of quality control in this study lies in obtaining the first-line data for the research assistant due to the isolation, and the delay of quality control only through the verification of EDC data. And these problems could be solved by using "core data targeting" quality control form. The features of this form include the concise content directly aiming at the main chart data in the research report for quality control, focusing on the implementation of the core elements of the programme and function of reminding and helping research assistants understand the capabilities of the project.
ABSTRACT
The design of research protocol and quality control are the key to ensure the quality of clinical trial. A randomized clinical trial regarding the effects of medication combined with acupuncture on live birth rate in polycystic ovary syndrome (PCOS), which was initially designed as a comparative effectiveness research, then added with an acupuncture control group and finally became a factorial analysis, is taken as an example to explain the protocol design and optimization process, demonstrating the high level of methodology design and international recognization. By a series of measurements, such as unified purchase of acupuncture equipment, multiple trainings and assessments for acupuncturists' knowledge and operation standardization, in-site supervision of local center experts, the standard operation of acupuncture could be ensured and the credibility and scientificity of research results could be improved.
ABSTRACT
<p><b>OBJECTIVE</b>This article aims to introduce the benefits of qualitative research and to discuss how such research can be applied to the study of polycystic ovary syndrome (PCOS).</p><p><b>DATA SOURCES</b>Relevant articles were published in English as of May 2013 from Pubmed. Terms "polycystic ovary syndrome/PCOS, qualitative research and methodology" were used for searching.</p><p><b>STUDY SELECTION</b>Articles studying PCOS with qualitative methods were reviewed. Articles associated with the use of qualitative research in clinical research were cited.</p><p><b>RESULTS</b>Six qualitative studies related to PCOS were found in the literature search. These studies addressed different aspects in PCOS women including their womanhood, lived experience, information need, and experience of treatment with acupuncture. Five of these six studies used phenomenology as guiding theory.</p><p><b>CONCLUSION</b>Quantitative research has been the dominant approach in the field so far, qualitative research is relevant to the advancement of PCOS.</p>
Subject(s)
Female , Humans , Acupuncture Therapy , Methods , Polycystic Ovary Syndrome , TherapeuticsABSTRACT
This article was inspired by the paper that Clinical Research of Traditional Chinese Medicine NeedsA Breakthrough, which was written by Shang Hongcai. This article took the 11th Five-year Plan of the National Science and Technology Support Project and the National Public Welfare Projects of Chinese Medicine, which were undertaken by the Heilongjiang Gynecology , which is one of the National Trial Bases of Chinese Medicine as an example to illustrate the Chinese medicine clinical trial management , achievement producing , and realization of achievement transformation . The emphasis should be made on the optimization of Chinese medicine clinical trial from the topic selection , operation mode and quality control . A comprehensive and detailed management system should be worked out to ensure the smooth conduction of clinical trials. The clinical research results should be clarified to achieve high quantity and quality outputs . The article was aimed to provide references for the development and breakthrough of Chinese medicine clinical trials .