Recently, the increasing risk of drug development has impelled pharmaceutical enterprises to improve ways of research and exploitation. Adaptive design has been proposed for decades. Although the theory of this design is not perfect, it has been recognized and applied worldwide as a decreasing risk of drug development to a certain extent. The traditional fixed design in western medicine isn’t entirely suitable for traditional Chinese medicine (TCM), while the adaptive design with integrity and variability features provides a new idea for TCM development. Hereby the application of adaptive design in TCM is regarded as an important procedure for promoting TCM modernization, and it has a wide prospective.
The method of evaluating clinical efficacy of traditional Chinese medicine is one of the hotspots in the field of traditional Chinese medicine in recent years. How to dynamically evaluate individual efficacy is one of the key scientific problems to explain the clinical efficacy of traditional Chinese medicine. At present, there are no recognized methods of evaluating individual efficacy of traditional Chinese medicine. In this study, we provided a method of dynamically evaluating individual efficacy of traditional Chinese medicine based on Bayesian N-of-1 trials after analyzing the current status of researches on methods of evaluating individual efficacy of traditional Chinese medicine. This method has the advantages of both N-of-1 trials and Bayesian multilevel models. It is feasible to evaluate individual efficacy of traditional Chinese medicine from the perspective of the design and analysis method. This study can provide an important basis for enriching and improving the methodology of evaluating individual efficacy of traditional Chinese medicine.
Evidence-based medicine advocates to support clinical decision-making with the best evidence, which is useful to objectively evaluate the clinical efficacy of traditional Chinese medicine and optimize clinical diagnosis and treatment. However, significant individualized characteristics identified from syndrome differentiation and treatment are incompatible with evidence-based clinical decision-making, which highlights population-level evidence, to some extent. In recent years, a number of new methods and technologies have been introduced into individualized clinical efficacy evaluation research of traditional Chinese medicine to assist managing and processing complex and multivariate information. These methods and technologies share similarities with evidence-based medicine, and are expected to link the clinical practice of traditional Chinese medicine with evidence-based clinical decision-making. They will guide the development of evidence-based clinical decision-making in traditional Chinese medicine.
In recent years, clinical research shows the trend of globalization. Due to characteristics of the huge number and relative concentration of patients, the wide variety of diseases, a high patient enrolment rate, lower trials costs, and so on, China and India become a focus of this trend. However, China and India also have their own advantages in the aspects of diseases, infrastructure, policies, regulations, regulatory environment, language, and culture. The key question to address is: how to increase the shares in the trial market in the future and to enhance the international status of China’s clinical research? Before we answer this question, we must understand the present situations of clinical research resources in China and India. So, we searched the relevant literature at home and abroad by computer and hand to analyze advantages and efficiency of clinical research resources in China and India.
This paper introduced database resources, retrieval methods, boolean operators, wildcard characters and proximity operators of ProQuest Dialog. Integrated with characteristics of literature retrieval of systematic reviews, this paper also introduced how to search literature in ProQuest Dialog when conducting a systematic review, in order to help reviewers to reasonably choose databases and improve their searching efficiency.
Data management system is a major factor affecting the quality of clinical trial. Development of data management system include a steering group and data safety and monitoring board, data collection, database, performance of the data safety and monitoring, as well as locking of database. This article provides key issues of the five parts so as to help researchers understand the clinical trial data management system.
Compared with traditional clinical trials, the real-world studies set higher requirements on the authenticity (reality), applicability, and timeliness of the evidence obtained. In this paper, we brought up a hypothesis that creating synergies between observational and experimental studies may meet these requirements. And then it was discussed in three aspects including providing evidence, research design and execution. In addition, data analysis facilitated generating efficient and robust evidence which was in support of decision making. Finally, some enlightenment may be offered for Traditional Chinese Medicine evaluation methods based on the synergies of both study types.
ObjectiveUsing SYRCLE tool (the SYstematic Review Centre for Laboratory animal Experimentation) to evaluate the risk of bias of animal studies in stroke field published in Chinese journals, identify problems of these studies in design, implementation and measurement, in order to provide references for improving the quality of animal studies in China. MethodsWe searched databases including CBM, VIP, CNKI and WanFang Data from inception to December 31st, 2014. Two reviewers independently screened literature, extracted data, and assessed the risk of bias of included animal studies using SYRCLE tool developed by the National Centre for the Replacement, Refinement and Reduction of Animals in Research. ResultsA total of 582 studies were included. The assessment results showed that the number of reported items with "Low Risk" in SYRCLE, which have 22 items, reported in >50% of the 4 items and in <30% the 16 items in articles of animals experiments. More than 99% of the studies fulfilled the 3 items and more than 17% of the articles to meet the 10 items while less than 1% of the documents met the 17 items. The quality of studies increased excepted the period of 2010 to 2014. The methodological quality of animal experiments presented a trend of increasing and no significant differences were found in CSCD indexed or not. ConclusionThe methodological quality of animal experiments of stroke is poor in China in terms of the selection bias, implementation bias, measurement bias, withdraw bias and reporting bias.