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 two factors that affect enrollment of participants and the process of intervention in randomizedcontrolled pragmatic trials are similar to the situation of clinical practice, thus its effects are similar to the situation ofclinical practice. Therefore, when one estimates an intervention’s effect on a patient, it will be more similar to a real clinicalsituation than results taken from an explanatory trial. Due to the introduction of interventions and process variables usedin a pragmatic trial that conform to traditional Chinese medicine and acupuncture practices, more and more interest isgrowing among researchers in the traditional Chinese medicine field. This article introduces the principles and conceptsof the pragmatic trial, and the key points of design via some samples.
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.
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.
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.
ObjectivesTo systematically review the efficacy of traditional Chinese medicine for arrhythmia caused by anthracycline drugs.MethodsPubMed, EMbase, The Cochrane Library, CBM, CNKI, WanFang Data databases were electronically searched to collect randomized controlled trials (RCTs) on the efficacy of traditional Chinese medicine for arrhythmia caused by anthracycline drugs from inception to October 2017. Two reviewers independently screened literature, extracted data and evaluated risk of bias of included studies. Meta-analysis was then performed by Revman 5.3 software.ResultsA total of 4 RCTs involving 312 patients were included. The results of meta-analysis showed that: the incidence of tachycardia in the Wenxin granule treatment group was lower than that in the control group (RR=0.35, 95%CI 0.18 to 0.67, P=0.002). Baoxinkang was more effective than antioxidant western medicine in protecting myocardial SOD activity (RR=2.25, 95%CI 1.74 to 2.76, P<0.000 01). But there was no significant difference between two groups on the incidence of atrial premature beats (RR=0.40, 95%CI 0.15 to 1.08,P=0.07), premature ventricular contractions (RR=0.56, 95%CI 0.23 to 1.34, P=0.19) and atrial fibrillation (RR=0.41, 95%CI 0.11 to 1.53, P=0.18). In addition, there was no significant difference between Wenxin granules and amiodarone in treating arrhythmia induced by anthracycline. The addition of Wenxin granules on the basis of anthracycline antitumor chemotherapy regimens was not effective in delaying disease progression compared with anthracycline alone. Wenxin granules could not change the SOD level of breast cancer patients with cardiotoxicity caused by anthracycline chemotherapy, compared with chemotherapy and basic treatment.ConclusionsThe current evidence shows that Wenxin granules can prevent and reduce anthracycline-induced tachycardia, but its efficacy in improving the overall efficiency, preventing and reducing atrial premature beats, premature ventricular contractions, atrial fibrillation, and SOD levels are unclear. Baoxinkang can protect myocardial SOD activity. Due to limited quality and quantity of the included studies, more high quality studies are required to verify above conclusions.
In order to mediate the contradiction between the high quantity and low quality of Traditional Chinese Medicine (TCM) clinical research, to avoid blind research and waste of resources, and to promote the benign development of TCM clinical research, we proposed carrying out health research priority setting on the TCM clinical research. This paper defined the main content of TCM clinical research and briefly introduced the research status of priority setting methods. We described a five-step process of the TCM priority setting research: setting the research scope and plan, establishing the working group, mapping the research field, identifying priority research areas, reporting, evaluating and updating the research. It is expected that this area will receive the attention of relevant researchers, policy makers and research funders.
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.
Objective To systematically review the intervention effects and safety of cardiovascular polypill for the relevant risk factors of coronary heart disease. Methods The randomized clinical trials (RCTs) on polypill in intervening coronary heart disease were searched in PubMed, CENTRAL, ICTRP, CBM, CNKI, WanFang and VIP from their inception to September 2012. Two reviewers independently screened the literature according to the inclusion and exclusion criteria, extracted the data, and assessed the methodological quality. Then the analysis was conducted. Results A total of 5 RCTs from overseas were included. The descriptive analysis showed that: a) as for blood pressure, polypill was obviously superior to placebo in reducing SBP and DBP with a significant difference, but it didn’t reveal difference compared to the hypotensive drugs used alone; b) as for serum lipid, polypill was obviously superior to placebo in reducing TC, TG and LDL-C with a significant difference, but there was no difference between polypill and standard drug treatment; c) as for glucose, polypill was obviously superior to placebo in reducing glucose with a significant difference; d) as for adverse reaction, such adverse events as cough, bleeding tendency or gastritis, liver and kidney dysfunction were reported in the included studies; e) as for drug compliance, polypill showed no differences compared with either standard treatment or placebo. Conclusion Polypill has intervention effects on the relevant factors of coronary heart disease, such as hypertension and serum lipid, etc. Due to quantity limitation of the included trials, the above conclusion still needs to be further proved by performing more large scale and high quality studies. For lack of adequate evidence, this review does not recommend polypill as a primary care for cardiovascular disease.