scholarly journals Assessment of clinical trials registered at clinical trial registry of India over past decade: an audit

2016 ◽  
Vol 3 (4) ◽  
pp. 238 ◽  
Author(s):  
Shruti S Bhide ◽  
Firoz Tadvi ◽  
Mitesh Maurya ◽  
Sunil Bhojne ◽  
Pragya Chandrakar
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Pharmaceutical Industry ◽  
Clinical Research ◽  
Clinical Studies ◽  
Descriptive Statistics ◽  
Trial Registry ◽  
Clinical Trial Registry ◽  
Post Graduate ◽  
The Past

<p class="abstract"><strong>Background:</strong> Clinical trial registry of India (CTRI) was launched in 2007. In this audit we attempted to assess the clinical research scenario over the past decade by looking at the information about clinical studies registered at the CTRI from 2007 to 2016.</p><p class="abstract"><strong>Methods:</strong> We accessed the official website of the CTRI i.e. www.ctri.nic.in and the required information was downloaded and descriptive statistics were used.</p><p class="abstract"><strong>Results:</strong> We found that the number of studies went on increasing from 31 in 2007 to 7060 in 2016 (as on 22<sup>nd</sup> June 2016). Majority studies were of interventional in nature as compared to observational and bioavailability and bioequivalence (BABE) studies. Pharmaceutical industry sponsored studies were comparatively higher in number than any other sponsored studies. However their number went on decreasing, while increase in registration of post graduate thesis and investigator sponsored studies was observed.</p><p><strong>Conclusions:</strong> Though a decrease in Pharmaceutical industry sponsored studies was observed the overall clinical research scenario appears to have improved due to investigator initiated studies and post graduate thesis.</p>

scholarly journals Chinese Clinical Studies for Pharmacological Treatments of Coronavirus Disease 2019 (COVID-19)

2020 ◽  
Author(s):  
Ru Han ◽  
Yitong Wang ◽  
Monique Dabbous ◽  
Shuyao Liang ◽  
Tingting Qiu ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Clinical Studies ◽  
Observational Studies ◽  
Reference Group ◽  
Descriptive Analysis ◽  
Secondary Analysis ◽  
Trial Registry ◽  
Primary Analysis ◽  
Clinical Trial Registry

Objectives: This study aims to identify, report, and analyze registered and published clinical trials and observational studies for the pharmacological treatment of COVID-19 conducted in China. Methods: A strategic search was conducted via the Chinese Clinical Trial Registry to identify and extract clinical trials and observational studies registered and conducted in China for the pharmacological treatment of COVID-2019 between January 1st, 2020 and March 21st, 2020. This was further supplemented by searches conducted via the China National Knowledge Infrastructure (CNKI) database, the MEDLINE database, the World Health Organization (WHO) database, and MedRxiv and BioRxiv electronic platforms for preprint articles, published up until April 8th, 2020. Studies available in Chinese and English were included in the searches and extracted. A primary descriptive analysis was performed for registered clinical trials and observational studies identified in the Chinese Clinical Trial Registry based on the extraction of the following clinical study information: trial ID, planned date of enrollment, recruitment status, study design, population, sample size, intervention/exposure group, control /reference group, dosage, and primary outcomes. A secondary descriptive analysis was performed for published clinical trials and observational studies identified from the supplementary databases based on the extraction of the following published clinical study information: study design, population, intervention/exposure group, control /reference group and main results as appropriate. Results: A total of 221 clinical trials and observational studies were included from all databases searched. From the Chinese Clinical Trial Registry, 195 registered clinical studies including 170 clinical trials and 25 observational studies were identified and included for primary analysis. From the supplementary databases, 26 published clinical studies including 8 clinical trials and 18 observational studies were included for secondary analysis. Of these 26 published clinical studies, 18 studies, including 3 clinical trials and 15 observational studies were identified from CNKI, 2 studies including 1 clinical trial and 1 observational study from MEDLINE, 2 including 1 clinical trials and 1 observational studies from the WHO database, and 4 including 3 clinical trials and 1 observational studies from MedRxiv and BioRxiv platforms. In the primary analysis, among the 170 clinical trials included from the Chinese Clinical Trial Registry, 101 investigated western medicines (WMs), while 15 investigated Traditional Chinese Medicines (TCMs), and 54 investigated a combination of TCMs and WMs. Among the 25 included observational studies from the Chinese Clinical Trial Registry, 2 investigated WMs, 2 investigated TCMs, and 21 investigated a combination of TCMs and WMs. The total number of exposed patients in all 195 clinical studies from the Chinese Clinical Trial Registry amounted to 24,500. In the secondary analysis, treatment with Lopinavir-ritonavir and treatment with Hydroxychloroquine was not associated with a difference from standard of care in the rate of RT-PCR negativity; treatment with a combination of Lopinavir-ritonavir, interferon &alpha;, and Lian-Hua-Qing-Wen capsule was found to significantly improve the effective rate of treatment compared with Interferon &alpha; combined with Lian-Hua-Qing-Wen capsule. Conclusions: China is generating a massive source of evidence that is critical for defeating the COVID-19 pandemic. Not only the clinical experience, but also the scientific evidence should be shared with the global scientific community.

scholarly journals Impact of the Clinical Trials Act on noncommercial clinical research in Japan: An interrupted time-series analysis

2021 ◽  
Author(s):  
Ikuyo Tsutsumi ◽  
Yusuke Tsutsumi ◽  
Chikashi Yoshida ◽  
Takuya Komeno ◽  
Yuichi Imanaka
Keyword(s):  
Clinical Trial ◽  
Time Series ◽  
Clinical Trials ◽  
Clinical Studies ◽  
Medical Information ◽  
Interrupted Time Series ◽  
University Hospital ◽  
Trial Registry ◽  
Clinical Trial Registry ◽  
The Impact

AbstractBackgroundThe number of new noncommercial clinical studies conducted in Japan declined within the first year of the implementation of the Clinical Trials Act (CTA) on April 1, 2018. This study aimed to examine the impact of the CTA’s enforcement on the number of new noncommercial clinical studies registered in the Japanese Clinical Trial Registry.MethodsAn interrupted time-series design was used in the analysis, which was conducted for the period of April 2015 to March 2019. We collected data for trials registered in the Clinical Trial Registry, managed by the University Hospital Medical Information Network.ResultsIn total, 35,811 studies were registered in the registry; of these, 16,455 fulfilled the eligibility criteria. The difference in the trend of monthly number of new trials after CTA enforcement decreased significantly by 15.0 trials (95% CI, −18.7 to −11.3), and the level decreased by 40.8 (95% CI, −68.2 to −13.3) from the pre-enforcement to the post-enforcement period. Multigroup analyses indicated that the act exerted a significant effect on the trend of new clinical trials, particularly those with smaller sample sizes, interventional study designs, and nonprofit funding sponsors.ConclusionsThe number of Japanese noncommercial clinical studies declined significantly following implementation of the CTA. It is necessary to establish a system to promote clinical studies in Japan while ensuring transparency and safety.

scholarly journals Profiles of COVID-19 clinical trials in the Chinese Clinical Trial Registry

2020 ◽  
Vol 9 (1) ◽  
pp. 1695-1701 ◽  
Author(s):  
Peng Xu ◽  
Xiangyu Xing ◽  
Keying Yu ◽  
Zhiguo Lv ◽  
Huijing Cui ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Trial Registry ◽  
Clinical Trial Registry

scholarly journals Publication of lung cancer clinical trials in the Japanese Clinical Trial Registry

2018 ◽  
Vol 48 (11) ◽  
pp. 995-1000 ◽  
Author(s):  
Nobuaki Ochi ◽  
Tatsuyuki Kawahara ◽  
Yasunari Nagasaki ◽  
Nozomu Nakagawa ◽  
Tomoko Yamagishi ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Clinical Trial ◽  
Clinical Trials ◽  
Cancer Clinical Trials ◽  
Trial Registry ◽  
Clinical Trial Registry

Iranian clinical trials: An analysis of registered trials in International Clinical Trial Registry Platform (ICTRP)

2017 ◽  
Vol 10 (2) ◽  
pp. 91-96 ◽  
Author(s):  
Mansoureh Feizabadi ◽  
Fatima Fahimnia ◽  
Alireza Mosavi Jarrahi ◽  
Nader Naghshineh ◽  
Shahram Tofighi
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Trial Registry ◽  
Clinical Trial Registry ◽  
International Clinical Trial

scholarly journals The role of a data manager at a clinical trial center: the experience of the Alessandria hospital, Italy

2020 ◽  
Vol 8 (1) ◽  
Author(s):  
Fabio Giacchero ◽  
Carolina Pelazza ◽  
Serena Panpa ◽  
Marinella Bertolotti ◽  
Tatiana Bolgeo ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Clinical Research ◽  
Clinical Studies ◽  
Reference Period ◽  
Job Description ◽  
Data Manager

Objectives: To define the Data Manager (DM) job description within the Clinical Trial Center (CTC) of the Alessandria Hospital (AO AL). To identify the number of authorized clinical studies after the implementation of three DMs in the CTC of the AO AL. Methods: The activities of the DM within the CTC of the AO AL take place in the activation, management and conclusion of clinical trials. The activities were monitored through specific indicators from June 01st, 2019 to May 31st, 2020. Results: During the reference period, an increased authorized studies were observed. Conclusion: The implementation of DMs in the CTC of AO AL has been demonstrated the importance of the figure itself, which, although it has not professionally recognized yet, is found to be fundamental in clinical research.

scholarly journals Evaluation of knowledge, attitude and practices of postgraduate medical students towards clinical research in a tertiary care teaching hospital

2021 ◽  
Vol 10 (7) ◽  
pp. 800
Author(s):  
Sukhmeen Kaur Johar ◽  
Deepali L. Jaybhaye ◽  
Shruti Chandra ◽  
Prashant S. Mishra
Keyword(s):  
Clinical Trial ◽  
Medical Education ◽  
Graduate Students ◽  
Clinical Research ◽  
Tertiary Care ◽  
Willingness To Participate ◽  
Clinical Trial Registry ◽  
Cross Sectional ◽  
Post Graduate ◽  
Research Activities

Background: Clinical research is a component of medical and health research that facilitates valuable knowledge regarding diagnosis, prevention as well as treatment of a disease. Nowadays, the practise of medicine is evidence-based and combining medical education with clinical research provides a channel for translating scientifically advanced knowledge into better public health. The aim of the study was to assess knowledge (K), attitude (A), and practices (P) about clinical research among post graduate medical students.Methods: After obtaining institutional ethics committee approval, a cross-sectional and questionnaire-based study was conducted. A pre-structured and validated KAP questionnaire comprising of 25 questions (knowledge-15, attitude-5 and practices-5) was shared online through google forms with post graduate students. The responses to the questions were later marked correct or incorrect. The data was collected and compiled using Microsoft excel and expressed in percentage (%). Data analysis was performed using SPSS version 25.0.Results: 102 students responded to the questionnaire completely. Out of which males (55.9%) pre-dominated and majority of the PG students belonged to I year accounting for 40.2%. About 61.76% PG students were aware about a clinical research unit in the college. Majority of the students acknowledged the necessity of conducting clinical research and exhibited good knowledge about key concepts of clinical trials.  Even responses to questions pertaining to attitude towards clinical research were also majorly positive. On the contrary, more than 90% students had neither attended any workshop on ICH-GCP guidelines nor registered their academic study under clinical trial registry of India. However, 73.5% of them expressed their willingness to participate in a clinical trial in future.Conclusions: Although, assessment of knowledge and attitudes about clinical research among post graduate students showed positive results but discrepancies were observed in its practise. As such, this necessitates incorporation of clinical research activities into existing medical education system.

Sign in / Sign up

Export Citation Format

Share Document