scholarly journals An analysis of clinical trials registered with CTRI in India from 2007 to 2015

2016 ◽  
Vol 3 (3) ◽  
pp. 155
Author(s):  
Vihang S. Chawan ◽  
Sagar V. Badwane ◽  
Kalpesh V. Gawand ◽  
Maheshi U. Chhaya
Keyword(s):  
Clinical Trials ◽  
Gold Standard ◽  
Evidence Based ◽  
Trial Registry ◽  
Clinical Trial Registry ◽  
Negative Results ◽  
Potential Risks ◽  
Wide Gap ◽  
Based Medicine ◽  
Positive Results

<p class="abstract"><strong>Background:</strong> Clinical trials are gold standard in the field of evidence based medicine. Registration of clinical trials facilitates the dissemination of information among clinicians, researchers and patients. Earlier, researchers were interested only in publishing positive results of their study. The negative results were never published resulting in bias in reporting the results of such clinical trials. It is now mandatory to register all clinical trials done in India at National Institute of Medical Statistics (NIMS) hosted at Clinical Trial Registry - India (CTRI) website to ensure transparency, accountability and accessibility of clinical trials. This study was planned to analyze the number of clinical trials registered under CTRI from 2007 to 2015. The information regarding the registration of clinical trials was accessed from the website www.ctri.nic.in.</p><p class="abstract"><strong>Methods:</strong> The information on registered clinical trials was obtained from the website www.ctri.nic.in. The clinical trials registered with CTRI from 2007 to 2015 were noted for analysis.</p><p class="abstract"><strong>Results:</strong> Maximum number of clinical trials registered in the year 2015 (1113), followed by year 2014 (1089), 2013 (990), 2012 (959) and 2011 (748) while least number of clinical trials registered in the year 2007 (32). Results revealed that there is wide gap the number of clinical trials registered in between year 2007 to 2015 and also revealed that number of clinical trials registered are increasing in order from year 2007 to year 2015.  </p><strong>Conclusions:</strong> The registrations of clinical trials improve the reliability of data generated, assist clinicians to interpret research, minimizes duplication of trials and prevents exposure of volunteers to potential risks.

scholarly journals 4552 Pediatrician Readiness to Participate in Clinical Trials: Roles of interest, barriers and interventions

2020 ◽  
Vol 4 (s1) ◽  
pp. 64-65
Author(s):  
Beatrice Boateng ◽  
Jessica Snowden ◽  
Diana Munoz-Mendoza ◽  
Clare Nesmith ◽  
Frederick Barr ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Gold Standard ◽  
Online Survey ◽  
Randomized Clinical Trials ◽  
Evidence Based ◽  
Clinical Educator ◽  
Study Population ◽  
Pediatric Populations ◽  
Prior Experiences ◽  
Based Medicine

OBJECTIVES/GOALS: Clinical trials are the gold standard for developing evidence-based medicine. However, 20% of pediatric randomized clinical trials are discontinued and about 30% of completed trials go unpublished. (Pica and Bourgeois, 2016) Although patient recruitment is the most cited barrier to completing clinical trials, trials funded by academia are more likely discontinued compared to those funded by industry. This study is an attempt to gain additional insights into clinical trials in academic pediatrics. METHODS/STUDY POPULATION: Junior pediatrics faculty (Instructors and Assistant Professors) were recruited to participate in an online survey through RedCAP. The physicians were asked if they had prior experiences with clinical trials and whether they have interest in participating in clinical trials. Those interested were asked three additional questions: what role they were interested in, barriers to participating and interventions they thought would educate them about participating in clinical trials. RESULTS/ANTICIPATED RESULTS: Ninety two (92) out of 119 (77%) junior pediatrics faculty completed the survey. Twenty (20) pediatric subspecialties were represented and respondents were on various academic pathways. A third of the respondents (35%) had previously participated in clinical trials. A majority of the faculty respondents (84; 70%) are on the clinical educator pathway. The 13 respondents who were not interested in clinical trials indicated their preference for patient care, education and quality improvement. Of those interested in clinical trials, the top three preferred roles were site co-investigator (68%), help designing future protocol (47%) and site principal investigator (44%). Other than time, the top barriers to participation were a lack of awareness of what it takes to lead or engage in clinical trials (53%) and a lack of training on clinical trials (45%). Mentoring from an experienced clinical trialist emerged as the top preferred intervention (78%). DISCUSSION/SIGNIFICANCE OF IMPACT: Although limited to one institution, the findings of this study provide insights into pediatric faculty interest in clinical trials. If academic pediatricians are provided with mentoring, there could be an uptick in completed and published clinical trials involving pediatric populations.

scholarly journals Therapeutic clinical trials to combat COVID-19 pandemic in India: analysis from trial registry

2020 ◽  
Vol 0 (0) ◽  
Author(s):  
Angelika Batta ◽  
Raj Khirasaria ◽  
Vinod Kapoor ◽  
Deepansh Varshney
Keyword(s):  
Clinical Trials ◽  
De Novo ◽  
Treatment Options ◽  
Drug Repurposing ◽  
Trial Registry ◽  
Therapeutic Treatment ◽  
Clinical Trial Registry ◽  
Clear Cut ◽  
Therapeutic Trials ◽  
Microsoft Office

AbstractObjectivesWith the emergence of Novel corona virus, hunt for finding a preventive and therapeutic treatment options has already begun at a rapid pace with faster clinical development programs. The present study was carried out to give an insight of therapeutic interventional trials registered under clinical trial registry of India (CTRI) for COVID-19 pandemic.MethodsAll trials registered under CTRI were evaluated using keyword “COVID” from its inception till 9th June 2020. Out of which, therapeutic interventional studies were chosen for further analysis. Following information was collected for each trial: type of therapeutic intervention (preventive/therapeutic), treatment given, no. of centers (single center/multicentric), type of institution (government/private), study design (randomized/single-blinded/double-blinded) and sponsors (Government/private). Microsoft Office Excel 2007 was used for tabulation and analysis.ResultsThe search yielded total of 205 trials, out of which, 127 (62%) trials were interventional trials. Out of these, 71 (56%) were AYUSH interventions, 36 (28.3%) tested drugs, 9 (7%) tested a nondrug intervention, rest were nutraceuticals and vaccines. About 66 (56%) were therapeutic trials. Majority were single-centered trials, i.e. 87 (73.7%). Trials were government funded in 57 (48.3%) studies. Majority were randomized controlled trials, i.e. 67 (56.8%). AYUSH preparations included AYUSH-64, Arsenic Album, SamshamaniVati etc.ConclusionsThe number of therapeutic interventional clinical trials was fair in India. A clear-cut need exists for an increase in both quantity and quality of clinical trials for COVID-19. Drug repurposing approach in all systems of medicine can facilitate prompt clinical decisions at lower costs than de novo drug development.

Trends in randomized controlled trials in ENT: a 30-year review

1997 ◽  
Vol 111 (7) ◽  
pp. 611-613 ◽  
Author(s):  
K. W. Ah-See ◽  
N. C. Molony ◽  
A. G. D. Maran
Keyword(s):  
Clinical Trials ◽  
Clinical Practice ◽  
Randomized Controlled Trials ◽  
Gold Standard ◽  
Controlled Trials ◽  
Evidence Based ◽  
Controlled Clinical Trials ◽  
Medline Search ◽  
Randomized Controlled Clinical Trials ◽  
Randomized Controlled

AbstractThere is a growth in the demand for clinical practice to be evidence based. Recent years have seen a rise in the number of randomized controlled clinical trials (RCTS). Such trials while acknowledged as the gold standard for evidence can be difficult to perform in surgical specialities. We have recently identified a low proportion of RCTS in the otolaryngology literature. Our aim was to identify any trend in the number of published RCTS within the ENT literature over a 30-year period and to identify which areas of our speciality lend themselves to this form of study design. A Medline search of 10 prominent journals published between 1966 and 1995 was performed. Two hundred and ninety-six RCTS were identified. Only five were published before 1980. Two hundred (71 per cent) of RCTS were in the areas of otology and rhinology. An encouraging trend is seen in RCTS within ENT literature.

scholarly journals Bias against Vitamin C in Mainstream Medicine: Examples from Trials of Vitamin C for Infections

Life ◽  
2022 ◽  
Vol 12 (1) ◽  
pp. 62
Author(s):  
Harri Hemilä ◽  
Elizabeth Chalker
Keyword(s):  
Clinical Trials ◽  
Vitamin C ◽  
Common Cold ◽  
Evidence Based Medicine ◽  
Evidence Based ◽  
The Third ◽  
Nutritional Recommendations ◽  
Mainstream Medicine ◽  
The Common ◽  
Based Medicine

Evidence has shown unambiguously that, in certain contexts, vitamin C is effective against the common cold. However, in mainstream medicine, the views on vitamin C and infections have been determined by eminence-based medicine rather than evidence-based medicine. The rejection of the demonstrated benefits of vitamin C is largely explained by three papers published in 1975—two published in JAMA and one in the American Journal of Medicine—all of which have been standard citations in textbooks of medicine and nutrition and in nutritional recommendations. Two of the papers were authored by Thomas Chalmers, an influential expert in clinical trials, and the third was authored by Paul Meier, a famous medical statistician. In this paper, we summarize several flaws in the three papers. In addition, we describe problems with two recent randomized trial reports published in JAMA which were presented in a way that misled readers. We also discuss shortcomings in three recent JAMA editorials on vitamin C. While most of our examples are from JAMA, it is not the only journal with apparent bias against vitamin C, but it illustrates the general views in mainstream medicine. We also consider potential explanations for the widespread bias against vitamin C.

scholarly journals Intestinal Microbiota and Allergy. Probiotics and Prebiotics in Prevention and Treatment of Allergic Diseases

2019 ◽  
Vol 16 (1) ◽  
pp. 7-18 ◽  
Author(s):  
Svetlana G. Makarova ◽  
Leyla S. Namazova-Baranova ◽  
Oksana A. Ereshko ◽  
Dmitry S. Yasakov ◽  
Pavel E. Sadchikov
Keyword(s):  
Immune Response ◽  
Clinical Trials ◽  
Intestinal Microbiota ◽  
Practical Interest ◽  
Allergic Diseases ◽  
Evidence Based ◽  
Prevention And Treatment ◽  
The Impact ◽  
Positive Results ◽  
Intestinal Microbiocenosis

Intestinal microbiota is the factor that identifies considerably the human health. The impact of the microbial factor on a child begins long before his birth. Children have certain features in forming of immune response and intestinal microbiocenosis even before birth. Decline in diversity of intestinal microbiota is common in children with allergic disease even during first months of life, before allergic pathology development. Capabilities for microbiota development adjustment are sufficiently restricted. However it is clinically proven that early (within the first hours of life) breastfeeding attachment, breastfeeding itself within at least first 6 months of life, the use of prebiotics in milk formulas as well as the use of probiotics can give positive results on allergy management. In this review we present results of recent metaanalyses and consensus papers of international medical communities about use of probiotics and prebiotics in prevention and treatment of allergic diseases. Despite great scientific and practical interest to this topic, authors of metaanalyses bring our attention to the lack of evidence-based clinical trials.

scholarly journals Microfracture: State of the Art in Cartilage Surgery?

Cartilage ◽  
2017 ◽  
Vol 9 (4) ◽  
pp. 339-345 ◽  
Author(s):  
Florian Frehner ◽  
Jan P. Benthien
Keyword(s):  
Clinical Trials ◽  
Impact Factor ◽  
Sports Medicine ◽  
Time Frame ◽  
Evidence Based ◽  
Yearly Average ◽  
The Mean ◽  
Based Medicine ◽  
Number Of Citations ◽  
The Impact

Objective This study is a literature review from 2010 to 2014 concerning the quality of evidence in clinical trials about microfracture in attempt to repair articular cartilage. We have decided to focus on microfracturing, since this seems to be the best documented technique. Interest in evaluation of publication quality has risen in orthopaedic sports medicine recently. Therefore, we think it is necessary to evaluate recent clinical trials being rated for their evidence-based medicine (EBM) quality. We also compared the mean impact factor of the journals publishing the different studies as an indicator of the study’s citation and evaluated for a change over the studied time frame. Design To measure the EBM level, we applied the modified Coleman Methodology Score (CMS) introduced by Jakobsen. The impact factor, which is a measurement of the yearly average number of citations of articles recently published in that journal, was evaluated according to self-reported values on the corresponding journal’s website. Results We found that the mean CMS has not changed between 2010 and 2014. The mean impact factor has also not changed between 2010 and 2014. The CMS variance was high, pointing to different qualities in the evaluated studies. There is no evidence that microfracturing is superior compared to other cartilage repair procedures. Conclusion Microfracture cannot be seen as an evidence based procedure. Further research needs to be done and a standardization of the operating method is desirable. There need to be more substantial studies on microfracturing alone without additional therapies.

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