Registration, publication, and outcome reporting among pivotal clinical trials that supported FDA approval of high-risk cardiovascular devices before and after FDAAA

Abstract Background Selective registration, publication, and outcome reporting of clinical trials distort the primary clinical evidence that is available to patients and clinicians regarding the safety and efficacy of US Food and Drug Administration (FDA)-approved medical devices. The purpose of thi...

Descripción completa

Guardado en:

Detalles Bibliográficos
Autores principales:	Matthew J. Swanson, James L. Johnston, Joseph S. Ross
Formato:	article
Lenguaje:	EN
Publicado:	BMC 2021
Materias:	Clinical trials Publications Device approval United States Food and Drug Administration Medicine (General) R5-920
Acceso en línea:	https://doaj.org/article/71c1373a0d574587b16ff51186dbd5f8
Etiquetas:	Agregar Etiqueta Sin Etiquetas, Sea el primero en etiquetar este registro!

id	oai:doaj.org-article:71c1373a0d574587b16ff51186dbd5f8
record_format	dspace
spelling	oai:doaj.org-article:71c1373a0d574587b16ff51186dbd5f82021-11-21T12:31:20ZRegistration, publication, and outcome reporting among pivotal clinical trials that supported FDA approval of high-risk cardiovascular devices before and after FDAAA10.1186/s13063-021-05790-91745-6215https://doaj.org/article/71c1373a0d574587b16ff51186dbd5f82021-11-01T00:00:00Zhttps://doi.org/10.1186/s13063-021-05790-9https://doaj.org/toc/1745-6215Abstract Background Selective registration, publication, and outcome reporting of clinical trials distort the primary clinical evidence that is available to patients and clinicians regarding the safety and efficacy of US Food and Drug Administration (FDA)-approved medical devices. The purpose of this study is to compare registration, publication, and outcome reporting among pivotal clinical trials that supported FDA approval of high-risk (class III) cardiovascular devices before and after the FDA Amendment Act (FDAAA) was enacted in 2007. Methods Using publicly available data from ClinicalTrials.gov , FDA summaries, and PubMed, we determined registration, publication, and reporting of findings for all pivotal clinical studies supporting FDA approval of new high-risk cardiovascular devices between 2005 and 2020, before and after FDAAA. For published studies, we compared both the primary efficacy outcome with the FDA’s Premarket Approval (PMA) primary efficacy outcome and the published interpretation of findings with the FDA reviewer’s interpretation (positive, equivocal, or negative). Results Between 2005 and 2020, the FDA approved 156 high-risk cardiovascular devices on the basis of 165 pivotal trials, 48 (29%) of which were categorized as pre-FDAAA and 117 (71%) as post-FDAAA. Post-FDAAA, pivotal clinical trials were more likely to be registered (115 of 117 (98%) vs 24 of 48 (50%); p < 0.001), to report results (98 of 117 (87%) vs 7 of 48 (15%); p < 0.001) on ClinicalTrials.gov , and to be published (100 or 117 (85%) vs 28 of 48 (58%); p < 0.001) in peer-reviewed literature when compared to pre-FDAAA. Among published trials, rates of concordant primary efficacy outcome reporting were not significantly different between pre-FDAAA trials and post-FDAAA trials (24 of 28 (86%) vs 96 of 100 (96%); p = 0.07), nor were rates of concordant trial interpretation (27 of 28 (96%) vs 93 of 100 (93%); p = 0.44). Conclusions FDAAA was associated with increased registration, result reporting, and publication for trials supporting FDA approval of high-risk medical devices. Among published trials, rates of accurate primary efficacy outcome reporting and trial interpretation were high and no different post-FDAAA.Matthew J. SwansonJames L. JohnstonJoseph S. RossBMCarticleClinical trialsPublicationsDevice approvalUnited States Food and Drug AdministrationMedicine (General)R5-920ENTrials, Vol 22, Iss 1, Pp 1-10 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Clinical trials Publications Device approval United States Food and Drug Administration Medicine (General) R5-920
spellingShingle	Clinical trials Publications Device approval United States Food and Drug Administration Medicine (General) R5-920 Matthew J. Swanson James L. Johnston Joseph S. Ross Registration, publication, and outcome reporting among pivotal clinical trials that supported FDA approval of high-risk cardiovascular devices before and after FDAAA
description	Abstract Background Selective registration, publication, and outcome reporting of clinical trials distort the primary clinical evidence that is available to patients and clinicians regarding the safety and efficacy of US Food and Drug Administration (FDA)-approved medical devices. The purpose of this study is to compare registration, publication, and outcome reporting among pivotal clinical trials that supported FDA approval of high-risk (class III) cardiovascular devices before and after the FDA Amendment Act (FDAAA) was enacted in 2007. Methods Using publicly available data from ClinicalTrials.gov , FDA summaries, and PubMed, we determined registration, publication, and reporting of findings for all pivotal clinical studies supporting FDA approval of new high-risk cardiovascular devices between 2005 and 2020, before and after FDAAA. For published studies, we compared both the primary efficacy outcome with the FDA’s Premarket Approval (PMA) primary efficacy outcome and the published interpretation of findings with the FDA reviewer’s interpretation (positive, equivocal, or negative). Results Between 2005 and 2020, the FDA approved 156 high-risk cardiovascular devices on the basis of 165 pivotal trials, 48 (29%) of which were categorized as pre-FDAAA and 117 (71%) as post-FDAAA. Post-FDAAA, pivotal clinical trials were more likely to be registered (115 of 117 (98%) vs 24 of 48 (50%); p < 0.001), to report results (98 of 117 (87%) vs 7 of 48 (15%); p < 0.001) on ClinicalTrials.gov , and to be published (100 or 117 (85%) vs 28 of 48 (58%); p < 0.001) in peer-reviewed literature when compared to pre-FDAAA. Among published trials, rates of concordant primary efficacy outcome reporting were not significantly different between pre-FDAAA trials and post-FDAAA trials (24 of 28 (86%) vs 96 of 100 (96%); p = 0.07), nor were rates of concordant trial interpretation (27 of 28 (96%) vs 93 of 100 (93%); p = 0.44). Conclusions FDAAA was associated with increased registration, result reporting, and publication for trials supporting FDA approval of high-risk medical devices. Among published trials, rates of accurate primary efficacy outcome reporting and trial interpretation were high and no different post-FDAAA.
format	article
author	Matthew J. Swanson James L. Johnston Joseph S. Ross
author_facet	Matthew J. Swanson James L. Johnston Joseph S. Ross
author_sort	Matthew J. Swanson
title	Registration, publication, and outcome reporting among pivotal clinical trials that supported FDA approval of high-risk cardiovascular devices before and after FDAAA
title_short	Registration, publication, and outcome reporting among pivotal clinical trials that supported FDA approval of high-risk cardiovascular devices before and after FDAAA
title_full	Registration, publication, and outcome reporting among pivotal clinical trials that supported FDA approval of high-risk cardiovascular devices before and after FDAAA
title_fullStr	Registration, publication, and outcome reporting among pivotal clinical trials that supported FDA approval of high-risk cardiovascular devices before and after FDAAA
title_full_unstemmed	Registration, publication, and outcome reporting among pivotal clinical trials that supported FDA approval of high-risk cardiovascular devices before and after FDAAA
title_sort	registration, publication, and outcome reporting among pivotal clinical trials that supported fda approval of high-risk cardiovascular devices before and after fdaaa
publisher	BMC
publishDate	2021
url	https://doaj.org/article/71c1373a0d574587b16ff51186dbd5f8
work_keys_str_mv	AT matthewjswanson registrationpublicationandoutcomereportingamongpivotalclinicaltrialsthatsupportedfdaapprovalofhighriskcardiovasculardevicesbeforeandafterfdaaa AT jamesljohnston registrationpublicationandoutcomereportingamongpivotalclinicaltrialsthatsupportedfdaapprovalofhighriskcardiovasculardevicesbeforeandafterfdaaa AT josephsross registrationpublicationandoutcomereportingamongpivotalclinicaltrialsthatsupportedfdaapprovalofhighriskcardiovasculardevicesbeforeandafterfdaaa
_version_	1718418951344488448

Registration, publication, and outcome reporting among pivotal clinical trials that supported FDA approval of high-risk cardiovascular devices before and after FDAAA

Ejemplares similares