Clinic modelling randomised trials (CMRT’s) in animals as a new intermediate between biological experiments and randomised clinical trials: Application to antihistamine prophylaxis in anaesthesia and surgery

1998 ◽  
Vol 47 (0) ◽  
pp. 66-68
Author(s):  
I. Celik ◽  
W. Lorenz ◽  
B. Stinner, D. Duda, H. Sitter ◽  
S. Sauer
Keyword(s):  
Clinical Trials ◽  
Randomised Clinical Trials ◽  
Randomised Trials ◽  
Antihistamine Prophylaxis

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.

Anthroposophical Medicine: A systematic review of randomised clinical trials

2004 ◽  
Vol 116 (11-12) ◽  
pp. 407-408 ◽  
Author(s):  
Gunver S. Kienle ◽  
Harald J. Hamre ◽  
Helmm Kiene
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Randomised Clinical Trials ◽  
Anthroposophical Medicine

scholarly journals Prevention and management of idiosyncratic drug-induced liver injury: Systematic review and meta-analysis of randomised clinical trials

2021 ◽  
Vol 164 ◽  
pp. 105404
Author(s):  
Hao Niu ◽  
Judith Sanabria-Cabrera ◽  
Ismael Alvarez-Alvarez ◽  
Mercedes Robles-Diaz ◽  
Simona Stankevičiūtė ◽  
...  
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Liver Injury ◽  
Meta Analysis ◽  
Randomised Clinical Trials ◽  
Drug Induced ◽  
Drug Induced Liver Injury
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