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Verfasst von:Patry, Christian [VerfasserIn]   i
 Fichtner, Alexander [VerfasserIn]   i
 Höcker, Britta [VerfasserIn]   i
 Ries, Markus [VerfasserIn]   i
 Schmitt, Claus P. [VerfasserIn]   i
 Tönshoff, Burkhard [VerfasserIn]   i
Titel:Missing trial results
Titelzusatz:analysis of the current publication rate of studies in pediatric dialysis from 2003 to 2020
Verf.angabe:Christian Patry, Alexander Fichtner, Britta Höcker, Markus Ries, Claus Peter Schmitt, Burkhard Tönshoff
E-Jahr:2022
Jahr:23 April 2022
Umfang:10 S.
Fussnoten:Gesehen am 25.04.2022
Titel Quelle:Enthalten in: Pediatric nephrology
Ort Quelle:Berlin : Springer, 1987
Jahr Quelle:2022
Band/Heft Quelle:(2022) online ahead of print, 10 Seiten
ISSN Quelle:1432-198X
Abstract:BACKGROUND: Decision-making in the field of pediatric dialysis requires evidence from clinical trials, but, similar to other fields of pediatric medicine, might be affected by a low trial publication rate. - METHODS: We analyzed the current publication rate, the time to publication, and factors that might be associated with both rate of and time to publication in pediatric dialysis studies registered as completed on ClinicalTrials.gov from 2003 until November 2020. - RESULTS: Fifty-three respective studies were identified. These enrolled 7287 patients in total. 28 of 53 studies (52.8%) had results available. We identified a median time to publication of 20.5 months (range, 3-67). Studies published after the FDA Amendments Act establishment in 2007 were published faster (P = 0.025). There was no trend toward a higher publication rate of studies completed more recently (P = 0.431). 26 of 53 studies (49.1%) focused on medication and control of secondary complications of kidney failure. 12 of 53 studies (22.6%) enrolled only children, were published faster (P = 0.029) and had a higher 5-year publication rate (P = 0.038) than studies enrolling both children and adults. 25 of 53 studies (47.1%) were co-funded by industry. These were published faster (P = 0.025). - CONCLUSIONS: Currently, only 52.8% of all investigated studies in pediatric dialysis have available results, and the overall median time to publication did not meet FDA requirements. This might introduce a publication bias into the field, and it might negatively impact clinical decision-making in this critical subspecialty of pediatric medicine. A higher resolution version of the Graphical abstract is available as Supplementary information.
DOI:doi:10.1007/s00467-022-05553-x
URL:kostenfrei: Volltext: https://doi.org/10.1007/s00467-022-05553-x
 DOI: https://doi.org/10.1007/s00467-022-05553-x
Datenträger:Online-Ressource
Sprache:eng
Sach-SW:FDA Amendments Act
 Pediatric dialysis
 Publication rate
 Time to publication
K10plus-PPN:1800229003
Verknüpfungen:→ Zeitschrift
 
 
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