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10.1177/1740774515602868 http://scihub22266oqcxt.onion/10.1177/1740774515602868 C4783291!4783291!26350571     free     free     free Warning: file_get_contents(https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pubmed&id=26350571&cmd=llinks): Failed to open stream: HTTP request failed! HTTP/1.1 429 Too Many Requests in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 215 Deprecated: Implicit conversion from float 213.6 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534 Deprecated: Implicit conversion from float 213.6 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534       Clin+Trials 2016 ; 13 (2): 149-60 Nephropedia Template TP {{tp|p=26350571|t=2016. Risks of phase I research with healthy participants: A systematic review |pdf=|usr=}}{{26350571}} gab.com Text Risks of phase I research with healthy participants: A systematic review JO: Clin Trials http://www.kidney.de/pget.php?&tw=1&pmid=26350571 #FOAvip Background/Aims: Tragedies suggest that phase I trials in healthy participants may be highly risky. This possibility raises concern that phase I trials may exploit healthy participants to develop new therapies, making the translation of scientific discoveries ethically worrisome. Yet, few systematic data evaluate this concern. The present paper systematically reviews the risks of published phase I trials in healthy participants and evaluates trial features associated with increased risks. Methods: Data on adverse events and trial characteristics were extracted from all phase I trials published in PubMed, Embase, Cochrane, Scopus, and PsycINFO (1 January 2008 through 1 October 2012). Inclusion criteria were phase I studies that enrolled healthy participants of any age, provided quantitative adverse event (AE) data, and documented the number of participants enrolled. Exclusion criteria included 1) AE data not in English, 2) a ?challenge? study in which participants were administered a pathogen, and 3) no quantitative information about serious AE?s. Data on the incidence of adverse events, duration of AE monitoring, trial agent tested, participant demographics, and trial location were extracted. Results: In 475 trials enrolling 27,185 participants, there was a median of zero serious adverse events (interquartile range, 0-0) and a median of zero severe adverse events (interquartile range, 0-0) per 1000 treatment group participants/day of monitoring. The rate of mild and moderate adverse events was a median of 1147.19 per 1000 participants (interquartile range, 651.52 ? 1730.9) and 46.07 per 1000 participants/AE monitoring day (interquartile range, 17.80 ? 77.19). Conclusions: We conclude that phase I trials do cause mild and moderate harms but pose low risks of severe harm. To ensure that this conclusion also applies to unpublished trials, it is important to increase trial transparency. Twit Text FOAVip Risks of phase I research with healthy participants: A systematic review ????Clin Trials http://www.kidney.de/pget.php?&tw=1&pmid=26350571 #FOAvip Twit Text # Free Paper on # # # # # LINK http://www.kidney.de/pget.php?&tw=1&pmid=26350571 #FOAvip English Wikipedia <ref>{{Cite pmid|26350571}}</ref> Risks of phase I research with healthy participants: A systematic review #MMPMID26350571 Johnson RA; Rid A; Emanuel E; Wendler D Clin Trials 2016[Apr]; 13 (2): 149-60 PMID26350571show ga Background/Aims: Tragedies suggest that phase I trials in healthy participants may be highly risky. This possibility raises concern that phase I trials may exploit healthy participants to develop new therapies, making the translation of scientific discoveries ethically worrisome. Yet, few systematic data evaluate this concern. The present paper systematically reviews the risks of published phase I trials in healthy participants and evaluates trial features associated with increased risks. Methods: Data on adverse events and trial characteristics were extracted from all phase I trials published in PubMed, Embase, Cochrane, Scopus, and PsycINFO (1 January 2008 through 1 October 2012). Inclusion criteria were phase I studies that enrolled healthy participants of any age, provided quantitative adverse event (AE) data, and documented the number of participants enrolled. Exclusion criteria included 1) AE data not in English, 2) a ?challenge? study in which participants were administered a pathogen, and 3) no quantitative information about serious AE?s. Data on the incidence of adverse events, duration of AE monitoring, trial agent tested, participant demographics, and trial location were extracted. Results: In 475 trials enrolling 27,185 participants, there was a median of zero serious adverse events (interquartile range, 0-0) and a median of zero severe adverse events (interquartile range, 0-0) per 1000 treatment group participants/day of monitoring. The rate of mild and moderate adverse events was a median of 1147.19 per 1000 participants (interquartile range, 651.52 ? 1730.9) and 46.07 per 1000 participants/AE monitoring day (interquartile range, 17.80 ? 77.19). Conclusions: We conclude that phase I trials do cause mild and moderate harms but pose low risks of severe harm. To ensure that this conclusion also applies to unpublished trials, it is important to increase trial transparency. äRisks of phase I research with healthy participants: A systematic revi(epmc).pdf DeepDyve Pubget Overpricing