scholarly journals Frequently asked questions regarding treatment of Kawasaki disease

2018 ◽  
Vol 2017 (3) ◽  
Author(s):  
Jane C Burns
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Kawasaki Disease ◽  
Intravenous Immunoglobulin ◽  
Common Sense ◽  
Personal Experience ◽  
Case Series ◽  
Evidence Base ◽  
Acute Kawasaki Disease ◽  
The U.S

[first paragraph of article]The mainstay of therapy for acute Kawasaki disease (KD) is intravenous immunoglobulin (IVIG), which was first described in a case series from Japan and later proven through a nationwide clinical trial in the U.S. published in 1986. Since completion of the initial clinical trials, many questions have arisen regarding the nuances of KD treatment. In the absence of an evidence base, what follows is an attempt to devise rational responses to these questions that draw upon common sense and the personal experience of this author. 

Efficacy of Intravenous Immunoglobulin Combined with Prednisolone Following Resistance to Initial Intravenous Immunoglobulin Treatment of Acute Kawasaki Disease

2013 ◽  
Vol 163 (2) ◽  
pp. 521-526.e1 ◽  
Author(s):  
Tohru Kobayashi ◽  
Tomio Kobayashi ◽  
Akihiro Morikawa ◽  
Kentaro Ikeda ◽  
Mitsuru Seki ◽  
...  
Keyword(s):  
Kawasaki Disease ◽  
Intravenous Immunoglobulin ◽  
Acute Kawasaki Disease ◽  
Immunoglobulin Treatment

scholarly journals How to design and set up a clinical trial part 1: the research question

2019 ◽  
Vol 12 (3) ◽  
pp. 111-116
Author(s):  
Amarpreet Atwal ◽  
Philip E Benson
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Clinical Relevance ◽  
Clinical Care ◽  
Research Question ◽  
Relevant Information ◽  
Evidence Base ◽  
Human Participants ◽  
Set Up

Data from clinical trials involving human participants are essential in establishing an evidence base about the safety and effectiveness of our treatments. This first article describes the steps involved in designing and setting up a clinical trial, from establishing the research question(s) to searching the literature. Acquiring some knowledge about how to set up a clinical trial will allow the conscientious clinician to use the most relevant information to provide the highest possible standards of clinical care for his/her patients. CPD/Clinical Relevance: Even if a clinician is not, has never been, nor is ever planning to be involved in research, he/she should understand and be able to interpret the data from clinical trials.

Effects of an Art-Based Curriculum on Clinical Trials Attitudes and Breast Cancer Prevention Knowledge

2006 ◽  
Vol 33 (5) ◽  
pp. 664-676 ◽  
Author(s):  
Patricia M. Herman ◽  
Linda K. Larkey
Keyword(s):  
Breast Cancer ◽  
Clinical Trial ◽  
Clinical Trials ◽  
Education Program ◽  
Cancer Education ◽  
Controlled Study ◽  
Breast Health ◽  
Breast Cancer Education ◽  
The Difference ◽  
The U.S

Although Latinos now comprise the largest minority in the U.S. population, they continue to be seriously underrepresented in clinical trials. A nonrandomized controlled study of an innovative community-developed clinical trial and breast cancer education program targeting Latinas tested whether use of an art-based curriculum could increase willingness to enroll in six clinical trial scenarios and increase breast health and clinical trial knowledge. The art-based curriculum resulted in a larger increase in stated willingness to enroll across all clinical trial scenarios, and the difference was statistically significant ( p < .05) in three. Breast health and clinical trials knowledge increased similarly and significantly for both groups. The results of this study show promise for the use of a community-developed art-based curriculum in the Latina population to increase willingness to enroll in clinical trials.

The impact of newly approved drugs on clinical and operational strategies for multiple myeloma clinical trials.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. e19511-e19511
Author(s):  
Bhavani Krishnan ◽  
Bernadette Collins ◽  
Michael Jeffrey Cho ◽  
Tanya Partridge ◽  
Durga Vighnay ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Multiple Myeloma ◽  
Clinical Trials ◽  
Real World ◽  
Operational Strategies ◽  
Clinical Trial Enrollment ◽  
Near Term ◽  
Approved Drugs ◽  
The Impact ◽  
The U.S

e19511 Background: The global burden of multiple myeloma (MM) has increased steadily in last 3 decades. The IARC reports there were ~160,000 new cases worldwide in 2018. There has been an increase in the development and approval of more effective targeted therapy options (new immunomodulatory agents, proteasome inhibitors, and monoclonal antibodies); this, coupled with high adoption of these therapies presents a major challenge in enrollment of current ongoing clinical trials. We assessed the impact of near-term regulatory approvals on clinical trial enrollment. Methods: Public domain clinical trial enrollment data from MM studies (Phase I, I/II, II) closed/completed between 2011-2018 were used to determine enrollment trends pre and post 2014. We leveraged real-world medical claims data to project/model adoption of recently approved drugs in the U.S.; additionally, drug sales volume data was used to evaluate ex-US national adoption trends. The utilization rates of 5 recently approved drugs by regimen and line of treatment was determined. Results: In the U.S., there is a 13% increase in median enrollment duration with a corresponding 25% decrease in median p/s/m enrollment in MM studies, irrespective of phase, where enrollment was completed between 2015 -2018 compared to 2011-2014. We hypothesize that one of the factors for this increase in enrollment timeline is the approval and adoption of newly approved therapies post 2014. Two of the five recently approved drugs show a steady increase in the number of patients treated over 2016, 2017 and 2018, while one of the drugs plateaus over the same period. Outside of the U.S., our analysis confirms the existence of gaps in time to approval /adoption of recently approved drugs; for example, we observe a two-year delay in approval/adoption for one of the drugs in France compared to the other countries in Western Europe. Conclusions: There are over 10 investigational MM drugs currently in development which are anticipated to be granted approval between 2019-2021. Factoring the real-world adoption of near-term drug approval into global clinical and operational strategies offers insights into mitigating potential future enrollment challenges.

scholarly journals An investigation into the impact and implications of published papers from retracted research: systematic search of affected literature

BMJ Open ◽  
2019 ◽  
Vol 9 (10) ◽  
pp. e031909 ◽  
Author(s):  
Alison Avenell ◽  
Fiona Stewart ◽  
Andrew Grey ◽  
Greg Gamble ◽  
Mark Bolland
Keyword(s):  
Systematic Review ◽  
Clinical Trial ◽  
Clinical Trials ◽  
Research Misconduct ◽  
Evidence Base ◽  
Bibliographic Databases ◽  
Potential Influence ◽  
Relevant Research ◽  
Meta Analyses ◽  
The Impact

ObjectiveAnalyses of the impact of a body of clinical trial reports subject to research misconduct have been few. Our objective was to examine the impact on clinically relevant research of a group of researchers’ trial reports (‘affected trial reports’) affected by research misconduct, and whether identification of misconduct invoked a reappraisal.DesignIn 2016, we used five databases and search engines to identify ‘citing publications’, that is, guidelines, systematic and other reviews, and clinical trials citing any of 12 affected trial reports, published 1998–2011, eventually retracted for research misconduct. The affected trial reports were assessed more likely to have had impact because they had hip fracture outcomes and were in journals with impact factor >4. Two authors assessed whether findings of the citing publications would change if the affected trial reports were removed. In 2018, we searched for evidence that the citing publications had undertaken a reassessment as a result of the potential influence of the affected trial reports.ResultsBy 2016 the affected trial reports were cited in 1158 publications, including 68 systematic reviews, meta-analyses, narrative reviews, guidelines and clinical trials. We judged that 13 guidelines, systematic or other reviews would likely change their findings if the affected trial reports were removed, and in another eight it was unclear if findings would change. By 2018, only one of the 68 citing publications, a systematic review, appeared to have undertaken a reassessment, which led to a correction.ConclusionsWe found evidence that this group of affected trial reports distorted the evidence base. Correction of these distortions is slow, uncoordinated and inconsistent. Unless there is a rapid, systematic, coordinated approach by bibliographic databases, authors, journals and publishers to mitigate the impact of known cases of research misconduct, patients, other researchers and their funders may continue to be adversely affected.

scholarly journals Esketamine clinical trials: reply to Maju et al.

2020 ◽  
Vol 29 ◽  
Author(s):  
C. Gastaldon ◽  
D. Papola ◽  
G. Ostuzzi ◽  
C. Barbui
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Marketing Authorisation ◽  
Clinical Trial Data ◽  
Evidence Base ◽  
Trial Data ◽  
Regulatory Approval ◽  
Controversial Issues

Abstract Maju et al. provided clarifications on important and controversial issues related to esketamine clinical trial data, in response to a vivid debate triggered by the marketing authorisation recently granted by this new medicine. In this commentary, we reply to their comments attempting to critically discuss the evidence base needed to obtain regulatory approval.

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