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 study the application value of mixed formulations consisting of paraffin oil, dimethyl silicone oil, and senna preparations in treatment for incomplete adhesive intestinal obstruction after laparotomy. MethodsOne hundred and twentyeight patients diagnosed incomplete adhesive intestinal obstruction admitted to this hospital from March 2005 to May 2008 were randomly divided into trial group and control group. For the control group, the tradition therapy including fasting, gastrointestinal decompression, fluid replacement therapy, and enema with soap and water were used for treatment. For the trial group, the mixed formulations consisting of paraffin oil, dimethyl silicone oil, and senna preparations were injected into stomach by the nasogastric tube on the basis of traditional treatment used for the control group. Some indicators including the successful rate of nonoperative treatment, the time that obstructive symptoms resolved and returned to normal exhaust and defecation and normal diet, and recurrence rate were compared between two groups. ResultsThe successful rate of nonoperative treatmentin in the trial group were significantly higher than that in the control group 〔92.1% (70/76) versus 69.2% (36/52), Plt;0.01〕. The average time that recovered to normal exhaust and defecation in the trial group and the control group was 32.5 d and 47.8 d, respectively. The average time that recovered to normal diet in the trial group and the control group was 3.2 d and 5.3 d, respectively. The time that recovered to normal exhaust and defecation, and diet in the trial group were significantly shorter than those in the control group (Plt;0.01). The recurrence rate had no significant difference between two groups (Pgt;0.05). ConclusionThe mixed formulations consisting of paraffin oil, dimethyl silicone oil, and senna preparations improve recovery of intestinal function and reduce surgical intervention rate.
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.
Objectives To investigate calcium supplement in pregnancy for prevention of preeclampsia and relevant outcomes. Methods The Cochrane Library, PubMed, EMbase, CBM, WanFang Data, VIP and CNKI databases were searched online to collect randomized controlled trials (RCTs) of calcium supplement in pregnancy for prevention of preeclampsia and relevant outcomes from inception to July 2018. Two reviewers independently screened literature, extracted data and assessed the risk of bias of included studies. Meta-analysis was then performed by RevMan 5.3 software. Results A total of 33 RCTs involving 29 234 subjects were included. The results of meta-analysis showed that: compared with control group, the calcium supplement group was associated with lower preeclampsia (RR=0.48, 95%CI 0.38 to 0.62, P<0.000 01) and gestational hypertension (RR=0.65, 95%CI 0.55 to 0.77,P<0.000 01) incidence. The incidence of premature delivery, intrauterine growth retardation and severe preeclampsia in calcium supplement group was lower than that in placebo group, and the neonatal weight in calcium was higher than that in placebo group. However, there was no significant difference in the pregnancy cycle between the two groups. Conclusions Current evidence shows that calcium supplement is associated with lower risk of preeclampsia and gestational hypertension. Due to limited quality and quantity of the included studies, more high quality studies are required to verify the above conclusion.
Evidence mapping is a new type of comprehensive evidence research method that systematically collects, evaluates, and synthesizes existing evidence to clarify research status and gaps, thereby promoting scientific research and decision-making. After nearly 20 years of development, the methodology of evidence mapping has been continuously improved, and has gained wide attention and recognition from the international community. China has paid much attention to evidence mapping at an early stage, but there are relatively few theoretical and practical researches, and the concept definition is inconsistent. This paper introduces the methodology of evidence mapping production and reporting for researchers to use for reference, with a view to further promoting the research and development of evidence mapping in China.