Reporting bias in drug trials submitted to the Food and Drug Administration: review of publication and presentation.

<h4>Background</h4>Previous studies of drug trials submitted to regulatory authorities have documented selective reporting of both entire trials and favorable results. The objective of this study is to determine the publication rate of efficacy trials submitted to the Food and Drug Admin...

Descripción completa

Guardado en:

Detalles Bibliográficos
Autores principales:	Kristin Rising, Peter Bacchetti, Lisa Bero
Formato:	article
Lenguaje:	EN
Publicado:	Public Library of Science (PLoS) 2008
Materias:	Medicine R
Acceso en línea:	https://doaj.org/article/28965d5679dd481ba2ca126fb757c080
Etiquetas:	Agregar Etiqueta Sin Etiquetas, Sea el primero en etiquetar este registro!

id	oai:doaj.org-article:28965d5679dd481ba2ca126fb757c080
record_format	dspace
spelling	oai:doaj.org-article:28965d5679dd481ba2ca126fb757c0802021-11-25T05:37:27ZReporting bias in drug trials submitted to the Food and Drug Administration: review of publication and presentation.1549-12771549-167610.1371/journal.pmed.0050217https://doaj.org/article/28965d5679dd481ba2ca126fb757c0802008-11-01T00:00:00Zhttps://www.ncbi.nlm.nih.gov/pmc/articles/pmid/19067477/pdf/?tool=EBIhttps://doaj.org/toc/1549-1277https://doaj.org/toc/1549-1676<h4>Background</h4>Previous studies of drug trials submitted to regulatory authorities have documented selective reporting of both entire trials and favorable results. The objective of this study is to determine the publication rate of efficacy trials submitted to the Food and Drug Administration (FDA) in approved New Drug Applications (NDAs) and to compare the trial characteristics as reported by the FDA with those reported in publications.<h4>Methods and findings</h4>This is an observational study of all efficacy trials found in approved NDAs for New Molecular Entities (NMEs) from 2001 to 2002 inclusive and all published clinical trials corresponding to the trials within the NDAs. For each trial included in the NDA, we assessed its publication status, primary outcome(s) reported and their statistical significance, and conclusions. Seventy-eight percent (128/164) of efficacy trials contained in FDA reviews of NDAs were published. In a multivariate model, trials with favorable primary outcomes (OR = 4.7, 95% confidence interval [CI] 1.33-17.1, p = 0.018) and active controls (OR = 3.4, 95% CI 1.02-11.2, p = 0.047) were more likely to be published. Forty-one primary outcomes from the NDAs were omitted from the papers. Papers included 155 outcomes that were in the NDAs, 15 additional outcomes that favored the test drug, and two other neutral or unknown additional outcomes. Excluding outcomes with unknown significance, there were 43 outcomes in the NDAs that did not favor the NDA drug. Of these, 20 (47%) were not included in the papers. The statistical significance of five of the remaining 23 outcomes (22%) changed between the NDA and the paper, with four changing to favor the test drug in the paper (p = 0.38). Excluding unknowns, 99 conclusions were provided in both NDAs and papers, nine conclusions (9%) changed from the FDA review of the NDA to the paper, and all nine did so to favor the test drug (100%, 95% CI 72%-100%, p = 0.0039).<h4>Conclusions</h4>Many trials were still not published 5 y after FDA approval. Discrepancies between the trial information reviewed by the FDA and information found in published trials tended to lead to more favorable presentations of the NDA drugs in the publications. Thus, the information that is readily available in the scientific literature to health care professionals is incomplete and potentially biased.Kristin RisingPeter BacchettiLisa BeroPublic Library of Science (PLoS)articleMedicineRENPLoS Medicine, Vol 5, Iss 11, p e217; discussion e217 (2008)
institution	DOAJ
collection	DOAJ
language	EN
topic	Medicine R
spellingShingle	Medicine R Kristin Rising Peter Bacchetti Lisa Bero Reporting bias in drug trials submitted to the Food and Drug Administration: review of publication and presentation.
description	<h4>Background</h4>Previous studies of drug trials submitted to regulatory authorities have documented selective reporting of both entire trials and favorable results. The objective of this study is to determine the publication rate of efficacy trials submitted to the Food and Drug Administration (FDA) in approved New Drug Applications (NDAs) and to compare the trial characteristics as reported by the FDA with those reported in publications.<h4>Methods and findings</h4>This is an observational study of all efficacy trials found in approved NDAs for New Molecular Entities (NMEs) from 2001 to 2002 inclusive and all published clinical trials corresponding to the trials within the NDAs. For each trial included in the NDA, we assessed its publication status, primary outcome(s) reported and their statistical significance, and conclusions. Seventy-eight percent (128/164) of efficacy trials contained in FDA reviews of NDAs were published. In a multivariate model, trials with favorable primary outcomes (OR = 4.7, 95% confidence interval [CI] 1.33-17.1, p = 0.018) and active controls (OR = 3.4, 95% CI 1.02-11.2, p = 0.047) were more likely to be published. Forty-one primary outcomes from the NDAs were omitted from the papers. Papers included 155 outcomes that were in the NDAs, 15 additional outcomes that favored the test drug, and two other neutral or unknown additional outcomes. Excluding outcomes with unknown significance, there were 43 outcomes in the NDAs that did not favor the NDA drug. Of these, 20 (47%) were not included in the papers. The statistical significance of five of the remaining 23 outcomes (22%) changed between the NDA and the paper, with four changing to favor the test drug in the paper (p = 0.38). Excluding unknowns, 99 conclusions were provided in both NDAs and papers, nine conclusions (9%) changed from the FDA review of the NDA to the paper, and all nine did so to favor the test drug (100%, 95% CI 72%-100%, p = 0.0039).<h4>Conclusions</h4>Many trials were still not published 5 y after FDA approval. Discrepancies between the trial information reviewed by the FDA and information found in published trials tended to lead to more favorable presentations of the NDA drugs in the publications. Thus, the information that is readily available in the scientific literature to health care professionals is incomplete and potentially biased.
format	article
author	Kristin Rising Peter Bacchetti Lisa Bero
author_facet	Kristin Rising Peter Bacchetti Lisa Bero
author_sort	Kristin Rising
title	Reporting bias in drug trials submitted to the Food and Drug Administration: review of publication and presentation.
title_short	Reporting bias in drug trials submitted to the Food and Drug Administration: review of publication and presentation.
title_full	Reporting bias in drug trials submitted to the Food and Drug Administration: review of publication and presentation.
title_fullStr	Reporting bias in drug trials submitted to the Food and Drug Administration: review of publication and presentation.
title_full_unstemmed	Reporting bias in drug trials submitted to the Food and Drug Administration: review of publication and presentation.
title_sort	reporting bias in drug trials submitted to the food and drug administration: review of publication and presentation.
publisher	Public Library of Science (PLoS)
publishDate	2008
url	https://doaj.org/article/28965d5679dd481ba2ca126fb757c080
work_keys_str_mv	AT kristinrising reportingbiasindrugtrialssubmittedtothefoodanddrugadministrationreviewofpublicationandpresentation AT peterbacchetti reportingbiasindrugtrialssubmittedtothefoodanddrugadministrationreviewofpublicationandpresentation AT lisabero reportingbiasindrugtrialssubmittedtothefoodanddrugadministrationreviewofpublicationandpresentation
_version_	1718414566328631296

Reporting bias in drug trials submitted to the Food and Drug Administration: review of publication and presentation.

Ejemplares similares