scholarly journals Clinical Trials in Paediatrics — Regulatory and Methodological Aspects

10.5772/60611 ◽  
2015 ◽  
Author(s):  
Adriana Ceci ◽  
Viviana Giannuzzi ◽  
Donato Bonifazi ◽  
Mariagrazia Felisi ◽  
Fedele Bonifazi ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Methodological Aspects

Methodological aspects of clinical trials in non-ulcer dyspepsia with special reference to selectional factors

1985 ◽  
Vol 20 (sup109) ◽  
pp. 159-162 ◽  
Author(s):  
Olof Nryén ◽  
Sven Gustavsson ◽  
Hans-Olov Adami ◽  
Lars Lööf
Keyword(s):  
Clinical Trials ◽  
Special Reference ◽  
Non Ulcer Dyspepsia ◽  
Methodological Aspects

scholarly journals Systematic qualitative review of randomised trials conducted in nonsmall cell lung cancer with a noninferiority or equivalence design

2014 ◽  
Vol 45 (2) ◽  
pp. 511-524 ◽  
Author(s):  
Marianne Paesmans ◽  
Bogdan Grigoriu ◽  
Sebahat Ocak ◽  
Martine Roelandts ◽  
Jean-Jacques Lafitte ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Clinical Trials ◽  
Cell Lung Cancer ◽  
A Priori ◽  
Nonsmall Cell Lung Cancer ◽  
Phase Iii ◽  
Randomised Clinical Trials ◽  
Randomised Trials ◽  
Definition Of ◽  
Methodological Aspects

The use of noninferiority randomised trials for patients with advanced non-small cell lung cancer has emerged during the past 10–15 years but has raised some issues related to their justification and methodology. The present systematic review aimed to assess trial characteristics and methodological aspects.All randomised clinical trials with a hypothesis of noninferiority/equivalence, published in English, were identified. Several readers extracted a priori defined methodological information. A qualitative analysis was then performed.We identified 20 randomised clinical trials (three phase II and 17 phase III), 11 of them being conducted in strong collaboration with industry. We highlighted some deficiencies in the reports like the lack of justification for both the noninferiority assumption and the definition of the noninferiority margin, as well as inconsistencies between the results and the authors' conclusions. CONSORT guidelines were better followed for general items than for specific items (p<0.001).Improvement in the reporting of the meth"odology of noninferiority/equivalence trials is needed to avoid misleading interpretation and to allow readers to be fully aware of the assumptions underlying the trial designs. They should be restricted to limited specific situations with a strong justification why a noninferiority hypothesis is acceptable.

Methodological aspects of lung cancer clinical trials in the era of targeted agents

Lung Cancer ◽  
2010 ◽  
Vol 67 (2) ◽  
pp. 127-135 ◽  
Author(s):  
Massimo Di Maio ◽  
Ciro Gallo ◽  
Ermelinda De Maio ◽  
Alessandro Morabito ◽  
Maria Carmela Piccirillo ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Clinical Trials ◽  
Cancer Clinical Trials ◽  
Targeted Agents ◽  
Methodological Aspects

The Consolidated Standards of Reporting Trials (CONSORT): Better Presentation of Surgical Trials in the Journal of Hand Surgery

2004 ◽  
Vol 29 (6) ◽  
pp. 621-624 ◽  
Author(s):  
S. SAUERLAND ◽  
T. R. C. DAVIS
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Hand Surgery ◽  
Controlled Trials ◽  
Scientific Validity ◽  
Intention To Treat ◽  
Randomized Controlled ◽  
Study Results ◽  
Methodological Aspects ◽  
Treat Analysis

To assure readers that study results are scientifically valid, the methods of a clinical trial should be described adequately. Since randomization, blinding, and intention-to-treat-analysis are major bias-reducing techniques, these aspects should be reported most accurately. The Consolidated standards of reporting trials (CONSORT) are recommendations to improve the reporting of trials. CONSORT requires that trial authors describe basic methodological aspects that readers need to appraise the strengths of report ed clinical trials. This article presents the CONSORT recommendations and explains some of their main aspects. From now on, the Journal of Hand Surgery will use CONSORT to assist authors of randomized controlled trials in improving the description of their studies. We believe that this decision increases the scientific validity of study reports and helps readers when critically appraising articles.

Methodological aspects of clinical trials in diseases of the nervous system: conventional drug treatment versus gene therapy

1995 ◽  
Vol 8 (1,2) ◽  
pp. 73-74
Author(s):  
G. Bensimon ◽  
L. Lacomblez ◽  
V. Meininger ◽  
C.A. Valery ◽  
D. Klatzman
Keyword(s):  
Gene Therapy ◽  
Clinical Trials ◽  
Nervous System ◽  
Drug Treatment ◽  
Versus Gene ◽  
Conventional Drug ◽  
Methodological Aspects

scholarly journals Methodological Aspects of Randomized Controlled Trials for Tinnitus: A Systematic Review and How a Decision Support System Could Overcome Barriers

2021 ◽  
Vol 10 (8) ◽  
pp. 1737
Author(s):  
Dimitrios Kikidis ◽  
Evgenia Vassou ◽  
Winfried Schlee ◽  
Eleftheria Iliadou ◽  
Nikolaos Markatos ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Randomized Clinical Trials ◽  
Current Knowledge ◽  
Therapeutic Interventions ◽  
Future Studies ◽  
Randomized Controlled ◽  
Management Interventions ◽  
Wide Range ◽  
Tinnitus Treatment ◽  
Methodological Aspects

Although a wide range of tinnitus management interventions is currently under research and a variety of therapeutic interventions have already been applied in clinical practice, no optimal and universal tinnitus treatment has been reached yet. This fact is to some extent a consequence of the high heterogeneity of the methodologies used in tinnitus related clinical studies. In this manuscript, we have identified, summarized, and critically appraised tinnitus-related randomized clinical trials since 2010, aiming at systematically mapping the research conducted in this area. The results of our analysis of the 73 included randomized clinical trials provide important insight on the identification of limitations of previous works, methodological pitfalls or gaps in current knowledge, a prerequisite for the adequate interpretation of current literature and execution of future studies.

Multicenter Clinical Trials: Methodological Aspects

2015 ◽  
pp. 9-20
Author(s):  
T. A. Ban ◽  
W. H. Wilson
Keyword(s):  
Clinical Trials ◽  
Multicenter Clinical Trials ◽  
Methodological Aspects

Need for better evidences and methodological aspects of clinical trials in snakebites

Toxicon ◽  
2020 ◽  
Vol 177 ◽  
pp. S18
Author(s):  
Charles Gerardo
Keyword(s):  
Clinical Trials ◽  
Methodological Aspects

scholarly journals Methodological aspects of clinical trials in tinnitus: A proposal for an international standard

2012 ◽  
Vol 73 (2) ◽  
pp. 112-121 ◽  
Author(s):  
Michael Landgrebe ◽  
Andréia Azevedo ◽  
David Baguley ◽  
Carol Bauer ◽  
Anthony Cacace ◽  
...  
Keyword(s):  
Clinical Trials ◽  
International Standard ◽  
Methodological Aspects

Assessment of Executive Function in Clinical Trials

2003 ◽  
Vol 15 (S1) ◽  
pp. 219-224 ◽  
Author(s):  
Raija Ylikoski ◽  
Tuomo Hänninen
Keyword(s):  
Clinical Trials ◽  
Cognitive Impairment ◽  
Executive Function ◽  
High Risk ◽  
Neuropsychological Tests ◽  
Executive Dysfunction ◽  
Vascular Cognitive Impairment ◽  
New Methods ◽  
Definition Of ◽  
Methodological Aspects

Cerebrovascular disease and stroke are related to high risk of cognitive impairment. One of the main neuropsychological features in vascular cognitive impairment and vascular dementia is executive dysfunction. Definition of the essential subcomponents and concepts of executive function is important before determining the methodology in clinical trials. The scientific research and new methods on this topic are rapidly growing. We present some most commonly used neuropsychological tests and discuss the methodological aspects in light of clinical trials.

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