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10.1186/s13063-017-2168-0 http://scihub22266oqcxt.onion/10.1186/s13063-017-2168-0 C5597993!5597993!28903769     free     free     free Deprecated: Implicit conversion from float 231.6 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534 Deprecated: Implicit conversion from float 231.6 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534 Deprecated: Implicit conversion from float 231.6 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534 Deprecated: Implicit conversion from float 231.6 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534       Trials 2017 ; 18 (ä): ä Nephropedia Template TP {{tp|p=28903769|t=2017. Specific barriers to the conduct of randomised clinical trials on medical devices |pdf=|usr=}}{{28903769}} gab.com Text Specific barriers to the conduct of randomised clinical trials on medical devices JO: Trials http://www.kidney.de/pget.php?&tw=1&pmid=28903769 #FOAvip Background: Medical devices play an important role in the diagnosis, prevention, treatment and care of diseases. However, compared to pharmaceuticals, there is no rigorous formal regulation for demonstration of benefits and exclusion of harms to patients. The medical device industry argues that the classical evidence hierarchy cannot be applied for medical devices, as randomised clinical trials are impossible to perform. This article aims to identify the barriers for randomised clinical trials on medical devices. Methods: Systematic literature searches without meta-analysis and internal European Clinical Research Infrastructure Network (ECRIN) communications taking place during face-to-face meetings and telephone conferences from 2013 to 2017 within the context of the ECRIN Integrating Activity (ECRIN-IA) project. Results: In addition to the barriers that exist for all trials, we identified three major barriers for randomised clinical trials on medical devices, namely: (1) randomisation, including timing of assessment, acceptability, blinding, choice of the comparator group and considerations on the learning curve; (2) difficulties in determining appropriate outcomes; and (3) the lack of scientific advice, regulations and transparency. Conclusions: The present review offers potential solutions to break down the barriers identified, and argues for applying the randomised clinical trial design when assessing the benefits and harms of medical devices. Electronic supplementary material: The online version of this article (doi:10.1186/s13063-017-2168-0) contains supplementary material, which is available to authorized users. Twit Text FOAVip Specific barriers to the conduct of randomised clinical trials on medical devices ????Trials http://www.kidney.de/pget.php?&tw=1&pmid=28903769 #FOAvip Twit Text # Free Paper on # # # # # LINK http://www.kidney.de/pget.php?&tw=1&pmid=28903769 #FOAvip English Wikipedia <ref>{{Cite pmid|28903769}}</ref> Specific barriers to the conduct of randomised clinical trials on medical devices #MMPMID28903769 Neugebauer EAM; Rath A; Antoine SL; Eikermann M; Seidel D; Koenen C; Jacobs E; Pieper D; Laville M; Pitel S; Martinho C; Djurisic S; Demotes-Mainard J; Kubiak C; Bertele V; Jakobsen JC; Garattini S; Gluud C Trials 2017[]; 18 (ä): ä PMID28903769show ga Background: Medical devices play an important role in the diagnosis, prevention, treatment and care of diseases. However, compared to pharmaceuticals, there is no rigorous formal regulation for demonstration of benefits and exclusion of harms to patients. The medical device industry argues that the classical evidence hierarchy cannot be applied for medical devices, as randomised clinical trials are impossible to perform. This article aims to identify the barriers for randomised clinical trials on medical devices. Methods: Systematic literature searches without meta-analysis and internal European Clinical Research Infrastructure Network (ECRIN) communications taking place during face-to-face meetings and telephone conferences from 2013 to 2017 within the context of the ECRIN Integrating Activity (ECRIN-IA) project. Results: In addition to the barriers that exist for all trials, we identified three major barriers for randomised clinical trials on medical devices, namely: (1) randomisation, including timing of assessment, acceptability, blinding, choice of the comparator group and considerations on the learning curve; (2) difficulties in determining appropriate outcomes; and (3) the lack of scientific advice, regulations and transparency. Conclusions: The present review offers potential solutions to break down the barriers identified, and argues for applying the randomised clinical trial design when assessing the benefits and harms of medical devices. Electronic supplementary material: The online version of this article (doi:10.1186/s13063-017-2168-0) contains supplementary material, which is available to authorized users. äSpecific barriers to the conduct of randomised clinical trials on medi(epmc).pdf DeepDyve Pubget Overpricing