Objective To introduce how to use Stata software to implement the randomization of clinical trials. Methods Some examples were taken to describe how to implement the randomization of each kind of clinical trials. Results Stata implemented its required functions, such as simple randomization, stratified randomization, block randomization and the randomization of group treatment. Conclusion Stata can easily implement the randomization of clinical trials.
Based on the conclusion of recent clinical research conducted by foreign countries, there is no statistical difference in outcomes between real and placebo acupuncture. This paper analyzes the weaknesses of methods currently being used by foreign countries to compare the effects of real and placebo acupuncture, striving for a new way to test for the placebo effect; a way that is more scientific, more suitable for the current conditions of China, while at the same time capable of being recognized internationally. This paper describes a new acupuncture placebo-controlled method. Under the condition of complete patient trust, we may ensure an ideal placebo effect to the greatest extent by minimizing the potential curative effects in the placebo group. From the actual clinical practice, by randomized controlled trial comparing acupuncture and medicine, using the concept as the double-dummy clinical trail, this paper explores the “double-dummy – non-specific sites – random sampling” method in the clinical setting as a way to form a new acupuncture clinical research model of comparison between acupuncture and medicine.
To evaluate the clinical efficacy and safety of piperacillin/ tazobactam in the treatment of hospital acquired pneumonia( HAP) . Methods A multicenter, open-labeled, non-comparative clinical trial was conducted. Patients with HAP were administered intravenously with piperacillin /tazobactam( 4. 5 g) every 8 h for 7-14 days. Results A total of 250 patients were enrolled in this study and 246 subjects were clinical valuable. At the end point, the clinical efficacy rate was 81. 7% ( 201 /246) and the bacterial eradication rate was 74. 1% ( 83 /112) . The rate of drug related adverse events was 2. 8% ( 7 /250) , in which 4 cases had clinical significance ( rash, dyspnea, injection site pain and diarrhea, respectively) and 3 cases had abnormal laboratory findings ( hepatic dysfuction , eosinophilia and so on ) . All events were mild and transient . Conclusions Piperacillin/ tazobactamis effective and safe in the treatment of HAP, therefore, it is recommended as one of the first-line antibiotics to treat the patients with HAP.
Objective To evaluate the methodological quality of clinical trials on traditional Chinese medicine (TCM) nursing in recent six years.Methods Such databases as CNKI, VIP, WanFang Data and CBM were searched for collecting clinical trials on TCM nursing published from January 2006 to September 2011, and domestic primary nursing journals were also searched from January 2010 and September 2011. Methodological quality of included studies was assessed using quality assessment criteria of the Cochrane systematic review guideline. Results A total of 854 clinical trials were retrieved, including 706 (82.7%) randomized controlled trials (RCTs), 108 (12.6%) quasi-randomized controlled trials and 40 (4.7%) non-randomized controlled trials. In the methodological quality analysis, the comparability of baseline was mentioned in 784 trials (91.8%), a total of 498 (58.3%) reported definite diagnosis criteria. 178 (20.8%) reported exclusive criteria. 831 studies (97.3%) applied relevant statistical methods properly. However, only 55 trials (6.4%) mentioned the method of randomization sequence. 10 studies (1.2%) described the method of randomiztion assignment. Blinding was mentioned in 22 studies (2.6%). 98 trials (11.5%) did prospective follow-up. 93 trials (10.9%) had safety description. 20 trials (2.3%) reported lost and with drawl cases, but only 2 conducted intention-to-treat analysis. It was hard to determine whether there was selective reporting bias or not because all the studies did not have protocols. Only 21 studies (2.5%) mentioned the lack of outcome indicators which could be the evidence for existing of bias. By annual analysis, there were 81 trials which conformed to at least 2 low risk criteria. 10 trials (12.3%) was published in 2009, 26 trials (32.1%) published in 2010, and 27 trials published by September 2011, indicated an uptrend. Conclusions According to the Cochrane Collaboration’s tool for assessing risk of bias, the overall quality of clinical trials on TCM nursing is low with defects in different degrees, but it rises gradually over years.
The use of placebo controls in acupuncture trials has been an international concern for many years. We discussed some common problems in placebo controls and introduced four kinds of control methods (sham acupuncture, non-points acupuncture, minimal acupuncture and non-specific sites acupuncture). For sham acupuncture, non-points acupuncture and non-specific sites acupuncture, patients who have received acupuncture are liable to doubt the intervention they are taking. Minimal acupuncture has better reliability but is limited to use in many diseases for its physiological effect. Needling on some special parts of the body, for example, head and back side of the body, can make balance among factors as reliability, physiological effect and feasibility. This paper recommends a control method needling special parts according to the tradiontional acupuncture theory, which provides references for acupuncture clinical trials.
In order to improve the efficiency and guarantee the quality of the research of cross-regional multi-center clinical trials, with the combination of WIN 2003 Server IIS, SQL Server 2005 database and ASP.Net programming techniques, the Pocock and Simon minimized randomization system model facing the network was put forward, and this system based on that model was developed. The two sides in this system can achieve cooperation process from screening subjects, random allocation and drug management to filling electronic case report form. Moreover, the customers of this system can also publish official documents, exchange information and take full use of other available assistant functions through the office automation platform.
Objective To know the current status of multinational clinical trials (MNCTs) in East Asia, and to find the characters of MNCTs in countries/regions. Methods We downloaded the trial records of East Asia on May 8, 2008 from ClinicalTrials.gov and analyzed the data. Results The number of clinical trials sponsored by industry was 125 in China Mainland, 196 in Taiwan, 134 in Hong Kong, 264 in Korea, and 231 in Japan, respectively. Of the total 654 clinical trials in East Asia, 307 (47%) trials were MNCTs, most of which were conducted by Euro-American pharmaceutical companies, such as Pfizer, AstraZeneca, GlaxoSmithKline, Sanofi-Aventis and Bristol-Myers Squibb. Main therapeutic areas were cancer, followed by CNS diseases, cardiovascular diseases, infectious diseases, diabetes mellitus and respiratory diseases. Trials in phaseⅢwere 198 (65%), in phaseⅣ32 (10%), others in phaseⅡorⅠ. One hundred and ninety trials (62%) were double-blind clinical trials, about half of them using placebo. The characters of clinical trials in China were: ① Most of MNCTs were large scale trials with big sample size and many study sites; ② Most of local trials were phase Ⅲ trials; ③ There were no phase Ⅰ trials. The characters in Taiwan, Hong Kong and Korea were: 1) Most of the trials (84% in Taiwan and 93% in Hong Kong, 72% in Korea) were MNCTs, 2) A lot of large scale trials were conducted with each other. The characters of clinical trials in Japan were: ① MNCTs were only 17%, ② Large scale trials were fewer. Conclusion In East Asia, MNCTs are developing because of the initiation of the Europe and America pharmaceutical giants. It seems that the regulation in each country influence the development pattern of East Asia.
Objective To analyze the methodological quality of clinical trails on butylphthalide for cerebral ischemic stroke. Methods We collected all of the published clinical studies on butylphthalide for cerebral ischemic stroke in the world, and evaluated the methodological quality of the included studies according to clinical epidemiologic standard. The search time was from the establishment of each database to December, 2009. Results A total of 62 studies involving 5 762 patients were included. In all included studies, there were 56 randomized controlled trials (RCTs). A total of 8 studies described the method of random assignments. There were 4 multi-center randomized double-blind placebo-control trials. A total of 55 reported diagnosis criteria, 40 reported included criteria, 28 reported excluded criteria; 36 reported the curative efficacy at the end of the treatment, 51 assessed the neurological deficit score of patients before and after the treatment, 27 evaluated the ADL scores; 32 studies reported the side effects; 6 trials did not conduct intention-to-treat analysis even though some people withdrew the treatment because of the side effects or poor tolerance, etc. Conclusion Except for several high quality RCTs, current quality of some clinical trials on butylphthalide for ischemic stroke should be improved. We recommend that researchers should use internationally accepted consolidate standards of reporting trials (CONSORT) in future studies.
Objective To explore the current problems of training on ethics reviews in clinical trials in China. Methods We designed a quantitative survey to collect participants’ feedbacks on the training workshop on ethics reviews, which included contents, arrangement and structure, relevant to the workshop and their difficulties on ethics review work. Results A total of 60 questionnaires were sent and the response rate was 56.7% (34/60). A total of 120 participants from 18 provinces of China. Most of them were members of the virtual research center of evidence-base medicine of the Ministry of education. A total of 78.1% (25/32) participants thought they achieved their purpose after training, and 12.5% (4/32) did not meet their needs due to the poor language. The feedbacks of contents and quality of the workshop on ethics were shown in Table 1. The top useful contents (cents in 8-10) were: clinical trial registration, policies of WHO and China (93.8%, 30/32), data management and quality control in clinical trials, the roles of clinical trial registries and ethics committees (93.3%, 28/30), transparency in clinical trials (93.3%, 28/30), informed consent and beyond (91.8%, 31/34), and how to approach ethical review case studies (90.9%, 30/33), etc. Nobody considered workshop of less help.The majority (85.1%, 23/27) thought difficulties on ethic reviews existed and the main difficulties include: short of operational administrative rules (82.6%, 19/23), poor training opportunity (52.1%, 12/23), less supports from administrative (30.4%, 7/23) and financial (21.7%, 5/23), etc. The relevance (8-10 cents) to ethics workshop was: methods of teaching 75.9% (22/29), PPT 75% (21/28) and materials 42.9% (12/28). Conclusions There is some limitations in the first workshop on ethic reviews due to the lower response rate. However, it still shows the importance of training on ethics reviews. Training strategies should focus on different participants’ needs and the relevance to methods of teaching, and materials, etc. Workshopadopted lectures, cases studies analysis, more discussions and necessary translation will be welcome.