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 However, 20% of pediatric randomized clinical trials are discontinued and about 30% of completed trials go unpublished.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 Evidence-based medicine in obstetrics: can levels B and C recommendations be elevated to level A recommendations?

2009 ◽  
Vol 2 (2) ◽  
pp. 63-66
Author(s):  
◽  
Suneet P Chauhan ◽  
Eugene Chang ◽  
Brian Brost ◽  
Barbara Assel ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Evidence Based Medicine ◽  
Randomized Clinical Trials ◽  
Evidence Based ◽  
Obstetric Practice ◽  
Geographically Dispersed ◽  
Based Medicine

In this study, 65% (132/195) of level B/C obstetric recommendations are amenable to randomized clinical trials (RCTs) and seven were identified as most needed. The purpose of the survey was to evaluate levels B and C recommendations in obstetric practice bulletins (PBs) regarding the feasibility of performing RCT to elevate each subject to level A evidence. Eleven geographically dispersed physicians with experience in research reviewed levels B and C recommendations for the ethical and logistical feasibility of performing an RCT. In the 35 obstetric PBs, 195 level B/C recommendations were reviewed. The majority considered 47 (24%) topics unethical for an RCT and thought 16 (11%) did not need an RCT, thus leaving 132 (67%) levels B and C recommendations available for an RCT. Two-thirds of levels B and C recommendations in obstetric PB are amenable to RCTs and potentially becoming level A evidence.

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 Cochrane method for evaluating the efficacy of drugs, national contribution to international Cochrane collaboration

2019 ◽  
Vol 10 (4) ◽  
pp. 31-39
Author(s):  
D. L. Varganova ◽  
C. S. Pavlov ◽  
A. A. Svistunov
Keyword(s):  
Clinical Trials ◽  
Evidence Based Medicine ◽  
Randomized Clinical Trials ◽  
Meta Analysis ◽  
Scientific Evidence ◽  
State Level ◽  
Cochrane Collaboration ◽  
Historical Background ◽  
Evidence Based ◽  
Based Medicine

Modern approaches in medicine are based on the principles of evidence-based and balanced decisions in the age of personalized evidence-based medicine. Cochrane collaboration plays an important role in the development of evidence-based medicine; it’s methodology of meta-analysis, summarizing the scientific evidence from randomized clinical trials (RCTs) to answer the clinical questions about safety and effectiveness of various medical interventions. The article provides a brief historical background on the main milestones in the development of the methodology of evidence-based medicine, on the formation of Cochrane collaboration. The authors explain the concept of meta-analysis and systematic review, their types, methodological features and current requirements. The article defines the sequence of writing a metaanalysis: determing a task, inclusion and exclusion criteria, systematic search for randomized clinical trials, methodological assessment of studies, error risk assessment, meta-analysis models: fixed and random effects; determination of heterogeneity, presentation of meta-analysis results, assessment of confidence level using the GRADE system. The domestic experience of establishing evidence-based medicine in Russia and the contribution to the Cochrane international collaboration are represented separately: the opening of the first branch of the North European Cochrane Cooperation Center in Russia in 1998, the development of educational activities, the work of the Russian clone of the Cochrane Hepatobiliary Group and the appearance of the first qualitative meta-analysis, written by Russian authors, the introduction of an adapted system and the development of a national system for supporting medical decisions. The policy of introducing evidence-based medicine at the state level, legal acts, and the prospects for the development of evidence-based medicine in Russia are reflected.

scholarly journals Guidelines for Composing and Assessing a Paper on the Treatment of Pain: A Practical Application of Evidence-Based Medicine Principles to the Mint Randomized Clinical Trials

Pain Medicine ◽  
2018 ◽  
Vol 19 (11) ◽  
pp. 2127-2137 ◽  
Author(s):  
Zachary L McCormick ◽  
Yakov Vorobeychik ◽  
Jatinder S Gill ◽  
Ming-Chih J Kao ◽  
Belinda Duszynski ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Evidence Based Medicine ◽  
Randomized Clinical Trials ◽  
Evidence Based ◽  
Practical Application ◽  
Based Medicine

scholarly journals Clinical Trials: What, Where, When?

2018 ◽  
Vol 73 (5) ◽  
pp. 314-320
Author(s):  
Olga S. Kobyakova ◽  
Ivan A. Deev ◽  
Evgeny S. Kulikov ◽  
Roman I. Shtykh ◽  
Igor D. Pimenov ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Evidence Based Medicine ◽  
Randomized Clinical Trials ◽  
Professional Community ◽  
New Drugs ◽  
Evidence Based ◽  
Literature Analysis ◽  
Complete Knowledge ◽  
Reliable Knowledge ◽  
Based Medicine

Currently randomized clinical trials (RCTs) are a key stage in the development of new drugs. Despite the huge scale of the CT market, general awareness of the issue remains low and the society has formed a number of stereotypes and misconceptions about CTs. The presented review of Russian and foreign studies provides the information on the level of general awareness of clinical research in different countries, as well as among patients and practitioners. The conducted literature analysis demonstrates that awareness of clinical trials remains low both in society at large and among patients or in the professional community of practitioners. According to foreign studies, only 20–30% of respondents have heard anything about medical research while a relatively small percentage of respondents have more complete knowledge of RCTs. Among practitioners, only one in five is sufficiently informed about CTs while, according to different data, only about half fully realize what evidence-based medicine is and understand the importance of CTs as a source of reliable knowledge in everyday practice.

scholarly journals Treatment of macular diseases: an overview of key randomized clinical trials

2022 ◽  
Vol 14 (4) ◽  
pp. 137-148
Author(s):  
E. V. Bobykin ◽  
O. V. Morozova ◽  
N. S. Beresneva
Keyword(s):  
Clinical Trials ◽  
Evidence Based Medicine ◽  
Social Impact ◽  
Randomized Clinical Trials ◽  
Vision Loss ◽  
Age Related Macular Degeneration ◽  
Evidence Based ◽  
Age Related ◽  
Macular Diseases ◽  
Based Medicine

Macular diseases are traditionally a serious issue in ophthalmology, which has great social impact due to widespread occurrence and significant vision loss, often irreversible. Over the past few decades, the possibilities for the diagnosis and treatment of pathologies of the retina and choroid have been significantly expanded. Randomized clinical trials provided ophthalmologists with valuable information on the natural course and treatment strategies of common retinal diseases from the viewpoint of evidence-based medicine. However, due to the large number of trials conducted, it is often difficult to make an adequate choice of data to be used in daily practice. In this review, we systematize the most valuable randomized clinical trials. To this end, we selected 42 randomized clinical studies conducted between 1979 and 2019 and focused on the treatment of age-related macular degeneration (AREDS 1, AREDS 2, ANCHOR, MARINA, PrONTO, CATT, IVAN, VIEW 1, VIEW 2, EVEREST II, PLANET, SEVEN-UP, ALTAIR, HAWK, HARRIER), choroidal neovascularization of multiple etiology (myopic, post-inflammatory, angioid-streak-related, etc. — RADIANCE, REPAIR, MYRROR, MINERVA), diabetic eye lesions (diabetic retinopathy and diabetic macular edema — ETDRS, DRCR.net Protocols B, I, S and T, RISE, RIDE, VIVID-DME, VISTA-DME, MEAD, FAME), retinal vein occlusions (BVOS, CVOS, SCORE-CRVO, SCORE-BRVO, BRAVO, CRUISE, GALILEO, COPERNICUS, VIBRANT), as well as retinopathy of prematurity (CRYO-ROP, ETROP, RAINBOW). The review summarizes the main results of these studies, which confirm the effectiveness and safety of such treatment methods as antiVEGF and photodynamic therapy, retinal laser photocoagulation, cryotherapy, corticosteroids and nutraceuticals from the viewpoint of evidence-based medicine. For greater clarity, we provide a table summarizing information on each of the randomized clinical trials considered.

scholarly journals How much do we trust randomised clinical trials, and related guidelines for disease management? A critical appraisal

2020 ◽  
pp. 87-92
Author(s):  
Demosthenes B. Panagiotakos
Keyword(s):  
Clinical Trials ◽  
Disease Management ◽  
Evidence Based Medicine ◽  
Clinical Guidelines ◽  
Critical Appraisal ◽  
Randomized Clinical Trials ◽  
Evidence Based ◽  
Research Questions ◽  
Meta Analyses ◽  
Based Medicine

In the “era” of evidence-based medicine it is now well appreciated that systematic reviews and meta-analyses of randomized clinical trials are more powerful than other designs in their ability to answer research questions regarding the effectiveness of interventions. In this paper a critical appraisal is made regarding the validity of clinical trials and their role in formulating clinical guidelines.

Databases, registries, and quality of care

2017 ◽  
Author(s):  
Nicolas Danchin ◽  
Fiona Ecarnot ◽  
François Schiele
Keyword(s):  
Clinical Trials ◽  
Quality Of Care ◽  
Evidence Based Medicine ◽  
Randomized Clinical Trials ◽  
Cardiac Care ◽  
Evidence Based ◽  
Care Processes ◽  
Based Medicine ◽  
Acute Cardiac Care

This chapter will describe what databases and registries can provide for clinicians and researchers. It will also describe the respective position of randomized clinical trials and databases/registries as complementary pillars of evidence-based medicine, and how they are of particular importance in the field of acute cardiac care. Finally, the importance of databases in quality of care processes will be discussed.

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