scholarly journals Trends in Clinical Trial Registration in Dentistry: An Analysis of Registered Clinical Trials in the Clinical Research Information Service from 2013 to 2021 in South Korea

2021 ◽  
Vol 10 (3) ◽  
Author(s):  
Hye In Lee ◽  
Young-Ran Yoon
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
South Korea ◽  
Clinical Research ◽  
Information Service ◽  
Allocation Concealment ◽  
Research Information ◽  
Clinical Trial Registry ◽  
Clinical Trial Registration ◽  
Quality Reporting

The Clinical Research Information Service (CRIS) in South Korea provides a clinical trial registry platform in which all clinical trials should be mandatorily and prospectively registered. However, to date, the registration status of clinical trials in the field of dentistry has not been investigated. Therefore, this study aimed to provide an overview of the methodological design and trends of the registered clinical trials over a period of nine years. Information about registered clinical trials in the field of dentistry from the CRIS was comprehensively collected from 2013 to 2021. The details assessed from the collected trials include: type of sponsors, recruitment status, study design, randomization, allocation concealment, single or multi-centric, retrospective or prospective registration, and publication status. A total of 65 registered clinical trials were identified. The number of clinical trials in dentistry in South Korea was found to be less; however, an increasing trend was observed in the recent three years. A majority of the trials were interventional (81.5%), single-centered (86.2%), and conducted on patients (81.5%) and in private hospitals (55.4%). A considerable number of trials had an unclear phase, were retrospectively registered, and rarely published. Regarding the quality, most trials have inadequately reported the method of randomization and allocation concealment. The number of clinical trials in dentistry is still low in South Korea, and most of them were registered retrospectively. A poor-quality reporting of methods at several specific areas was observed. It is necessary for dental investigators to raise awareness of the need to register clinical trials.

scholarly journals Practical and conceptual issues of clinical trial registration for Brazilian researchers

2015 ◽  
Vol 134 (1) ◽  
pp. 28-33 ◽  
Author(s):  
Carolina Gomes Freitas ◽  
Thomas Fernando Coelho Pesavento ◽  
Maurício Reis Pedrosa ◽  
Rachel Riera ◽  
Maria Regina Torloni
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
International Committee ◽  
New Drugs ◽  
Trial Registration ◽  
Clinical Trial Registry ◽  
Clinical Trial Registration ◽  
Registration Process ◽  
Trial History ◽  
Definition Of

CONTEXT AND OBJECTIVE: Clinical trial registration is a prerequisite for publication in respected scientific journals. Recent Brazilian regulations also require registration of some clinical trials in the Brazilian Clinical Trials Registry (ReBEC) but there is little information available about practical issues involved in the registration process. This article discusses the importance of clinical trial registration and the practical issues involved in this process. DESIGN AND SETTING: Descriptive study conducted by researchers within a postgraduate program at a public university in São Paulo, Brazil. METHODS: Information was obtained from clinical trial registry platforms, article reference lists and websites (last search: September 2014) on the following topics: definition of a clinical trial, history, purpose and importance of registry platforms, the information that should be registered and the registration process. RESULTS: Clinical trial registration aims to avoid publication bias and is required by Brazilian journals indexed in LILACS and SciELO and by journals affiliated to the International Committee of Medical Journal Editors (ICMJE). Recent Brazilian regulations require that all clinical trials (phases I to IV) involving new drugs to be marketed in this country must be registered in ReBEC. The pros and cons of using different clinical trial registration platforms are discussed. CONCLUSIONS: Clinical trial registration is important and various mechanisms to enforce its implementation now exist. Researchers should take into account national regulations and publication requirements when choosing the platform on which they will register their trial.

Registration of Rectal Cancer-Related Clinical Trials on Chinese Clinical Trial Registry over past decades

2020 ◽  
Author(s):  
Jun-hong Hu ◽  
Shi-Can Zhou ◽  
Quan Zhang ◽  
Xing- Wang Li ◽  
Chen-Yu Wang ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Rectal Cancer ◽  
Clinical Trials ◽  
Trial Registry ◽  
Clinical Trial Registry ◽  
Clinical Trial Registration ◽  
Hospital Funding ◽  
Local Finance ◽  
Multicenter Clinical Trials ◽  
Data Library

Abstract Background This study investigated and analyzed rectal cancer-related clinical trials registered on Chinese Clinical Trial Registry (Chi-CTR) by the end of 2018. We aimed to discuss the characteristics and developmental trends. Methods The Chi-CTR database was searched and all clinical trials related to rectal cancer extracted. The time limit for the search was from the establishment of the data library to December 31, 2018. The characteristics of registered clinical trials were then analyzed. Results A total of 70 clinical trials were retreived. Beijing, Shandong, and Guangzhou accounted for 47.1% of the total number of registered clinical trials. Sichuan and Sun Yat-sen Universities having the highest number of registrations. The registration status of the 55 trials was prospective registration. The top sources of funding were self-financing (41.4%), hospital funding (22.9%) and local finance (15.7%). Out of the 43 randomized controlled trials, 39 were either blank or missing in the blinded section. The sample size of clinical trials was high in 100 to 199 cases. Only eight of the 70 trials were multicenter clinical trials. Conclusions Relevant departments should increase the registration of clinical trials, increase the awareness of registration, and promote the development of high-quality clinical trials. At the same time, researchers should raise the awareness of clinical trial registration, and actively carry out multi-center clinical trials.

Conception, Development, and Clinical Trial Design of Point-of-care Technologies: A Case of Improved FES Device Development

2016 ◽  
Vol 27 (1) ◽  
pp. 2-9
Author(s):  
Abhishek Biswas ◽  
C V Shendkar ◽  
Bikas K Arya ◽  
PK Lenka ◽  
Ratnesh Kumar ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Medical Device ◽  
Point Of Care ◽  
Clinical Trial Design ◽  
Trial Protocol ◽  
Trial Registry ◽  
Clinical Trial Registry ◽  
Clinical Trial Registration

Abstract Objective This article presents a case study on the development of an indigenous stimulator device, including the design of its clinical trials and the process of its clinical trial registration in the newly launched clinical trial registry- India (CTRI). The ethical and regulatory issues involved in medical device clinical trials in India are also discussed. Design and Methods The entire development and trial cycle of a new medical device from ideation to technology transfer is explained in this case of a newly developed indigenous FES device. The primary emphasis is on how to systematically analyse the global trial registry databases to adequately frame a medical device trial. With this case study, we present how to shortlist relevant trials; we then compare them and explain the valid methods for registering a trial protocol in the CTRI. Conclusions Our work can act as a model or guide for rehabilitation researchers in India, facilitating there work in the medical device design and trial protocol development. Though our trial has been designed for and registered in the Indian CTRI trial registry, our work can be equally useful for researchers abroad who desire to conduct their medical device trials in India.

scholarly journals Clinical Trial to Analyze the Effect of Oral Intake of Phellinus Linteus(Sanghuang) Extract on Immune Function: A Study Protocol for a Randomized, Double-blind Controlled Trial

2021 ◽  
Author(s):  
Yong Ho Ku ◽  
Hyun Lee ◽  
Hwa Yeon Ryu ◽  
Jae Hui Kang
Keyword(s):  
Clinical Trial ◽  
Clinical Research ◽  
Immune Function ◽  
Controlled Trial ◽  
Information Service ◽  
Laboratory Evaluation ◽  
Control Group ◽  
Phellinus Linteus ◽  
Research Information ◽  
Main Trial

Abstract Background: As Korea becomes an aging society, interest in health care has increased. In particular, there is an increasing demand for immune function improvement to prevent infectious diseases. Phellinus linteus (PL) has previously been shown to have immune-enhancing and anticancer effects. We aim to evaluate whether PL mycelium extract, cultured using the PL KCTC0399BP strain, has an increase in immune function using blood test indicators. This clinical trial is designed based on the results of a pilot study as the main trial.Methods: This clinical trial will be a randomized, double-blinded, placebo-controlled trial. Ninety-eight participants will be enrolled and randomly divided into two groups: experimental group (PL 1000 mg) and control group (placebo). Participants will be administered experimental food or placebo for 8 weeks. Blood tests will be performed before food intake and at 8 weeks after the start of the experiment. Laboratory evaluation items are as follows: natural killer cell activity, tumor necrosis factor-α, interferon-γ, interleukin (IL)-1β, IL-2, IL-6, IL-12, immunoglobulin (Ig)G1, IgG2, and IgM. We will mainly use the full analysis set to statistically analyze the effectiveness of treatment.Discussion: This study includes inclusion and exclusion criteria and a well-controlled intervention. This study evaluates the effect of PL extract on immune function and will contribute to knowledge on the value of PL as an immune function health functional food.Clinical research registration: This study has been registered at the Clinical Research Information Service (CRIS) of Korea: CRIS-KCT0005460. Registered , 12 October 2020, https://cris.nih.go.kr/cris/search/search_result_st01_en.jsp?seq=17761&ltype=&rtype=Trial status: This clinical trial is in the recruitment stage. Recruitment began in October 21, 2020 and will be completed in March 2021. This trial was registered at the Clinical Research Information Service of South Korea on October 12, 2020. (CRIS-KCT0005460)

scholarly journals COVID-19, SARS, MERS and Ebola: a comparative analysis registration of intervention clinical trials

2020 ◽  
Author(s):  
Yuxia Xiang ◽  
Zeyu Zhang ◽  
Chan Zeng ◽  
Zhanqing Hu ◽  
Yaxin Liu ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Clinical Research ◽  
Clinical Trial Registry ◽  
Drug Intervention ◽  
Short Period ◽  
Epidemic Period ◽  
Virulent Virus ◽  
Intervention Trials ◽  
Clinical Trial Program

Abstract BackgroundCOVID-19 is a novel and highly virulent virus, which caused a rapid and massive onset of clinical trials in a short period of time.With the aim to obtain suggestions in the guidance on performing emergency clinical trials, and control this virus in China and other countries and for the prevention of the onset of other infectious viruses in the future.MethodsCOVID-19, SARS, MERS and Ebola clinical trials registered in the Chinese clinical trial registry and clinical trials.gov were collected and analyzed and intervention protocols were compared, focusing on the analysis and comparison of the drug used. The search period ended on February 24, 2020.ResultsThe number of the registered COVID-19 clinical trials was 295. Among 203 intervention trials, 78.3% (159) were drug clinical trials, in which 46.3% (94) used chemical drugs and biological agents, 32.0% (65) were performed using Traditional Chinese Medicine (TCM) and integrated traditional Chinese and western medicine.The 159 COVID-19 trials were designed and analyzed with the highest proportion of blank randomized controls [45.9% (73)], and placebo randomized trials [14.5% (23)]. The drug mostly used was Lopinavir/Ritonavir (15.1%). The sample size ranged from 10 to 100 in 52.8% (84) trials. The number of the registered SARS was 6, MERS 15, and Ebola 97. Among 3 MERS and 19 Ebola drug intervention clinical trials, MERS and Ebola were randomized, blind, and placebo-controlled drug clinical trials accounting for 100% (3) and 31.6% (6), respectively, while SARS were vaccine trials, without drug intervention clinical trials registered.ConclusionsCompared with the SARS in 2003, the awareness and capability of clinical research in China greatly improved. However, some of the COVID-19 clinical trials and drug selection performed are somewhat disordered, requiring greater attention to the needs, science assumptions, ethics and quality management of the clinical research. Thus, during the epidemic period, the country should deliver guidance on how to perform appropriate emergency clinical trials, design a scientifically based clinical trial program and focus on researching drugs or vaccines that have great potential.

scholarly journals Visualization analysis of the characteristics of COVID-19 clinical trial

2020 ◽  
Author(s):  
Xiaoqiong Cai ◽  
Zengliang Zheng ◽  
Qianmin Su ◽  
Jihan Huang
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Primary Endpoint ◽  
Trial Registration ◽  
Integrated Medicine ◽  
Clinical Trial Registry ◽  
Clinical Trial Registration ◽  
Intervention Measures ◽  
Laboratory Index ◽  
Design Ideas

Abstract Objectives: This article points out the characteristics and trends of COVID-19 clinical trials through data collection, translation, mining and visualization to help in clinical trial design.Method: The registered data of COVID-19 clinical trials are gathered from the Chinese Clinical Trial Registry and ClinicalTrials.gov website transformed by Python, further demonstrated by visual tools.Results: As of 24:00 on March 28, 2020, totally 732 trial registration records have been retrieved. Overall, there are 406 (55.46%) interventional studies and 271 (37.02%) observational studies. Among interventional studies, 38.93% are randomized parallel trials, 55 (13.55%) trials considered time condition for clinical recovery as the primary endpoint, and 46 (11.33%) trials through clinical parameters and laboratory index as the primary endpoint. In the selection of intervention measures, chemical or biological agents was under the responsibility of 43.60%, of which antivirals accounted for 14.53%, antimalarials accounted for 8.87%, and 98 cases (24.14%) of studies involving Traditional Chinese Medicine or Integrated Medicine. In addition, joint network analysis of antivirals to explore the combination of drugs is further conducted.Conclusions: By Mining characteristic information of topical COVID-19 clinical trial registration, this article deserves further trial design ideas for researchers to enhance the effects.

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