Cargando…

The Definition of Placebo in the Informed Consent Forms of Clinical Trials

AIM: Lack of knowledge concerning the nature of placebo and why it is necessary may influence the participation of patients in clinical trials. The objective of the present study is to review how placebo is described in written information for participants in clinical trials to be evaluated by a Hum...

Descripción completa

Detalles Bibliográficos
Autores principales: Hernández, Astrid, Baños, Josep-E., Llop, Cristina, Farré, Magí
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Public Library of Science 2014
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4244087/
https://www.ncbi.nlm.nih.gov/pubmed/25423149
http://dx.doi.org/10.1371/journal.pone.0113654
_version_ 1782346183342030848
author Hernández, Astrid
Baños, Josep-E.
Llop, Cristina
Farré, Magí
author_facet Hernández, Astrid
Baños, Josep-E.
Llop, Cristina
Farré, Magí
author_sort Hernández, Astrid
collection PubMed
description AIM: Lack of knowledge concerning the nature of placebo and why it is necessary may influence the participation of patients in clinical trials. The objective of the present study is to review how placebo is described in written information for participants in clinical trials to be evaluated by a Human Research Ethics Committee. METHODS: All research protocols submitted for evaluation in a Spanish hospital during 2007–2013 were reviewed. The main characteristics of the studies using a placebo were collected. Three authors read each of them to determine how the term “placebo” was explained and if there was any comment on its efficacy and safety. RESULTS: Two thousand seven-hundred and forty research protocols were evaluated, of which three hundred and fifty-nine used a placebo. Pharmaceutical companies sponsored most placebo-controlled clinical trials (91.9%), and phase III studies were the commonest (59.9%). Oncology (15.0%), cardiology (14.2%), and neurology (13.1%) made the greatest contributions. A review of the informed consent forms showed that placebo was described in a similar manner in most studies: the explanation was limited to between four and eight words. Very few gave information about the risks of its use or adverse reactions from its administration. None of the studies provided details about the placebo effect. And 23 lacked any information about placebo at all. CONCLUSIONS: Explanations about placebo in informed consent forms is often scarce, and information about the placebo effect and associated risks are absent. This situation may influence a full understanding of placebo by participants in clinical trials and might reduce their informed decision to participate.
format Online
Article
Text
id pubmed-4244087
institution National Center for Biotechnology Information
language English
publishDate 2014
publisher Public Library of Science
record_format MEDLINE/PubMed
spelling pubmed-42440872014-12-05 The Definition of Placebo in the Informed Consent Forms of Clinical Trials Hernández, Astrid Baños, Josep-E. Llop, Cristina Farré, Magí PLoS One Research Article AIM: Lack of knowledge concerning the nature of placebo and why it is necessary may influence the participation of patients in clinical trials. The objective of the present study is to review how placebo is described in written information for participants in clinical trials to be evaluated by a Human Research Ethics Committee. METHODS: All research protocols submitted for evaluation in a Spanish hospital during 2007–2013 were reviewed. The main characteristics of the studies using a placebo were collected. Three authors read each of them to determine how the term “placebo” was explained and if there was any comment on its efficacy and safety. RESULTS: Two thousand seven-hundred and forty research protocols were evaluated, of which three hundred and fifty-nine used a placebo. Pharmaceutical companies sponsored most placebo-controlled clinical trials (91.9%), and phase III studies were the commonest (59.9%). Oncology (15.0%), cardiology (14.2%), and neurology (13.1%) made the greatest contributions. A review of the informed consent forms showed that placebo was described in a similar manner in most studies: the explanation was limited to between four and eight words. Very few gave information about the risks of its use or adverse reactions from its administration. None of the studies provided details about the placebo effect. And 23 lacked any information about placebo at all. CONCLUSIONS: Explanations about placebo in informed consent forms is often scarce, and information about the placebo effect and associated risks are absent. This situation may influence a full understanding of placebo by participants in clinical trials and might reduce their informed decision to participate. Public Library of Science 2014-11-25 /pmc/articles/PMC4244087/ /pubmed/25423149 http://dx.doi.org/10.1371/journal.pone.0113654 Text en © 2014 Hernández et al http://creativecommons.org/licenses/by/4.0/ This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are properly credited.
spellingShingle Research Article
Hernández, Astrid
Baños, Josep-E.
Llop, Cristina
Farré, Magí
The Definition of Placebo in the Informed Consent Forms of Clinical Trials
title The Definition of Placebo in the Informed Consent Forms of Clinical Trials
title_full The Definition of Placebo in the Informed Consent Forms of Clinical Trials
title_fullStr The Definition of Placebo in the Informed Consent Forms of Clinical Trials
title_full_unstemmed The Definition of Placebo in the Informed Consent Forms of Clinical Trials
title_short The Definition of Placebo in the Informed Consent Forms of Clinical Trials
title_sort definition of placebo in the informed consent forms of clinical trials
topic Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4244087/
https://www.ncbi.nlm.nih.gov/pubmed/25423149
http://dx.doi.org/10.1371/journal.pone.0113654
work_keys_str_mv AT hernandezastrid thedefinitionofplacebointheinformedconsentformsofclinicaltrials
AT banosjosepe thedefinitionofplacebointheinformedconsentformsofclinicaltrials
AT llopcristina thedefinitionofplacebointheinformedconsentformsofclinicaltrials
AT farremagi thedefinitionofplacebointheinformedconsentformsofclinicaltrials
AT hernandezastrid definitionofplacebointheinformedconsentformsofclinicaltrials
AT banosjosepe definitionofplacebointheinformedconsentformsofclinicaltrials
AT llopcristina definitionofplacebointheinformedconsentformsofclinicaltrials
AT farremagi definitionofplacebointheinformedconsentformsofclinicaltrials