Therapeutic misconception in clinical trials: Fighting against it and living with it

A clinical trial seeks information for the benefit of future patients and not necessarily for those who participate in the study. However, there are patients who believe that they will receive a direct therapeutic benefit by participating in a clinical trial, the so-called «therapeutic misconception...

Full description

Saved in:
Bibliographic Details
Published inRevista clínica espanõla (English edition) Vol. 214; no. 8; pp. 470 - 474
Main Authors Dal-Ré, R., Morell, F., Tejedor, J.C., Gracia, D.
Format Journal Article
LanguageEnglish
Published Spain Elsevier España 01.11.2014
Subjects
Clinical research
Clinical trials
Consentimiento informado
Definición
Definition
Ensayos clínicos
Equívoco terapéutico
Hoja de información para el participante
Informed consent
Investigación clínica
Oncology
Oncología
Participants information sheet
Placebo
Prevalence
Prevalencia
Therapeutic misconception
Prevalence
Clinical trials
Definition
Clinical research
Oncology
Equívoco terapéutico
Consentimiento informado
Ensayos clínicos
Investigación clínica
Definición
Prevalencia
Oncología
Placebo
Informed consent
Participants information sheet
Therapeutic misconception
Hoja de información para el participante
Online AccessGet full text

Cover

Abstract A clinical trial seeks information for the benefit of future patients and not necessarily for those who participate in the study. However, there are patients who believe that they will receive a direct therapeutic benefit by participating in a clinical trial, the so-called «therapeutic misconception». In this article, we describe the nature and extent of therapeutic misconception, which researchers can also experience. Its presence is especially important in phase 1 oncology trials and those with placebo group. To limit its occurrence, investigators have to ensure that participant information sheet are well written and to establish an effective and transparent discussion during the process of obtaining informed consent so that patients understand all aspects of their participation in the research and appreciate what this participation entails. Un ensayo clínico busca obtener datos para el beneficio de futuros pacientes y no necesariamente para los que participan en él. Sin embargo, hay pacientes que creen que obtendrán un beneficio terapéutico directo por participar en un ensayo clínico: es el denominado «equívoco terapéutico». En este artículo se describe la naturaleza y la extensión del equívoco terapéutico, que también pueden presentar los investigadores. Su presencia es especialmente relevante en ensayos con grupo placebo y en los de fase 1 de oncología. Para intentar limitar su aparición hay que asegurar que las hojas de información para los participantes estén bien redactadas, y que los investigadores establezcan una conversación efectiva y transparente en el proceso de obtención del consentimiento informado, de forma que el paciente conozca todos los matices de su participación en la investigación y valore lo que esto significa.
AbstractList A clinical trial seeks information for the benefit of future patients and not necessarily for those who participate in the study. However, there are patients who believe that they will receive a direct therapeutic benefit by participating in a clinical trial, the so-called «therapeutic misconception». In this article, we describe the nature and extent of therapeutic misconception, which researchers can also experience. Its presence is especially important in phase 1 oncology trials and those with placebo group. To limit its occurrence, investigators have to ensure that participant information sheet are well written and to establish an effective and transparent discussion during the process of obtaining informed consent so that patients understand all aspects of their participation in the research and appreciate what this participation entails.
A clinical trial seeks information for the benefit of future patients and not necessarily for those who participate in the study. However, there are patients who believe that they will receive a direct therapeutic benefit by participating in a clinical trial, the so-called «therapeutic misconception». In this article, we describe the nature and extent of therapeutic misconception, which researchers can also experience. Its presence is especially important in phase 1 oncology trials and those with placebo group. To limit its occurrence, investigators have to ensure that participant information sheet are well written and to establish an effective and transparent discussion during the process of obtaining informed consent so that patients understand all aspects of their participation in the research and appreciate what this participation entails. Un ensayo clínico busca obtener datos para el beneficio de futuros pacientes y no necesariamente para los que participan en él. Sin embargo, hay pacientes que creen que obtendrán un beneficio terapéutico directo por participar en un ensayo clínico: es el denominado «equívoco terapéutico». En este artículo se describe la naturaleza y la extensión del equívoco terapéutico, que también pueden presentar los investigadores. Su presencia es especialmente relevante en ensayos con grupo placebo y en los de fase 1 de oncología. Para intentar limitar su aparición hay que asegurar que las hojas de información para los participantes estén bien redactadas, y que los investigadores establezcan una conversación efectiva y transparente en el proceso de obtención del consentimiento informado, de forma que el paciente conozca todos los matices de su participación en la investigación y valore lo que esto significa.
Author Tejedor, J.C.
Morell, F.
Dal-Ré, R.
Gracia, D.
Author_xml – sequence: 1
  givenname: R.
  surname: Dal-Ré
  fullname: Dal-Ré, R.
  email: rafael.dalre@fuam.uam.es
  organization: Investigación Clínica, Programa BUC (Biociencias UAM+CSIC), Centro de Excelencia Internacional, Universidad Autónoma de Madrid, Madrid, Spain
– sequence: 2
  givenname: F.
  surname: Morell
  fullname: Morell, F.
  organization: Servicio de Neumología, Hospital Universitario Valld’Hebrón, Barcelona, Spain
– sequence: 3
  givenname: J.C.
  surname: Tejedor
  fullname: Tejedor, J.C.
  organization: Servicio de Neonatología, Hospital Universitario de Móstoles, Móstoles, Madrid, Spain
– sequence: 4
  givenname: D.
  surname: Gracia
  fullname: Gracia, D.
  organization: Departamento de Medicina Preventiva, Salud Pública e Historia de la Ciencia, Universidad Complutense, Madrid, Spain
BackLink https://www.ncbi.nlm.nih.gov/pubmed/24837147$$D View this record in MEDLINE/PubMed
BookMark eNp9kN1Kw0AQhRep2Fr7BILsCyTO_iTZCl5IsSoUvKnXy3azSaekm7JJK769W6vilVczDOfMnPkuycC33hFyzSBlwPLbTRqs83XKgckURAqQn5ER55lMlCrk4E8_JJOu2wAA42ya5XBBhlwqUTBZjMhyuXbB7Ny-R0u32NnWW7frsfUUPbUNerSmoX1A03R3dI71ukdfU1Mb9F1PsafGl7TBw3H6jv06jq7IeRXlbvJdx-Rt_ricPSeL16eX2cMisaxgRcIzp5TJSxc_qlwlBFcrB1JUUGSg7FTEmLkwhgNwW-ZCZlFaTZWUBTdGWDEm4rTXhrbrgqv0LuDWhA_NQB8x6Y3-wqSPmDQIHTFF183Jtduvtq789fxAiYL7k8DF7Ad0QXcWXeRSYnC212WL_x74BHV8ezA
CitedBy_id crossref_primary_10_1155_2014_676023
Cites_doi 10.1186/1471-2431-7-12
10.2307/3562038
10.2307/3564408
10.2307/3564231
10.1157/13089991
10.1136/jme.2003.006247
10.1186/1472-6939-14-28
10.1016/j.ejca.2008.08.013
10.1001/jamapediatrics.2013.1050
10.1097/COC.0b013e3181b20641
10.1080/13607863.2011.602962
10.1016/j.cct.2009.01.002
10.1136/jme.2006.018960
10.1016/0160-2527(82)90026-7
10.1177/1740774512456455
10.1016/j.cct.2007.04.005
10.1001/archinte.168.12.1294
10.1186/1472-6939-12-18
10.1157/13126218
10.1016/S0277-9536(03)00338-1
10.1056/NEJMsa021182
10.1001/jama.2013.282034
10.1056/NEJMsa042220
10.1002/cncr.27397
10.1093/jnci/94.24.1847
10.1371/journal.pmed.0040340
10.1353/hcr.2007.0092
10.1016/j.cct.2010.05.004
10.1371/journal.pmed.0040324
ContentType Journal Article
Copyright 2014 Elsevier España, S.L.U.
Copyright © 2014 Elsevier España, S.L.U. All rights reserved.
Copyright_xml – notice: 2014 Elsevier España, S.L.U.
– notice: Copyright © 2014 Elsevier España, S.L.U. All rights reserved.
DBID NPM
AAYXX
CITATION
DOI 10.1016/j.rceng.2014.03.006
DatabaseName PubMed
CrossRef
DatabaseTitle PubMed
CrossRef
DatabaseTitleList PubMed
Database_xml – sequence: 1
  dbid: NPM
  name: PubMed
  url: https://proxy.k.utb.cz/login?url=http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed
  sourceTypes: Index Database
DeliveryMethod fulltext_linktorsrc
Discipline Medicine
DocumentTitleAlternate El equívoco terapéutico en los ensayos clínicos: combatirlo y convivir con él
EISSN 2254-8874
EndPage 474
ExternalDocumentID 10_1016_j_rceng_2014_03_006
24837147
S2254887414000873
Genre Journal Article
GroupedDBID --M
.~1
0R~
1~.
4.4
457
4G.
65R
7-5
8P~
AACTN
AAEDT
AAEDW
AAIAV
AAIKJ
AAKOC
AALRI
AAOAW
ABLVK
ABMAC
ABMZM
ABXDB
ABYKQ
ACDAQ
ACGFS
ACRLP
ADBBV
ADECG
ADEZE
AEBSH
AEKER
AFKWA
AFTJW
AFXIZ
AGHFR
AGUBO
AGYEJ
AIEXJ
AIKHN
AITUG
AJBFU
AJOXV
AJRQY
ALMA_UNASSIGNED_HOLDINGS
AMFUW
AMRAJ
ANZVX
AXJTR
BKOJK
BLXMC
BNPGV
EFJIC
EFLBG
FDB
FIRID
FNPLU
FYGXN
GBLVA
HZ~
KOM
LCYCR
M41
MO0
O-L
O9-
OAUVE
P-8
P-9
PC.
Q38
RIG
ROL
SDF
SPCBC
SSH
SSZ
T5K
~G-
AAQFI
AAXKI
AAXUO
AFJKZ
AKRWK
NPM
AAYXX
CITATION
ID FETCH-LOGICAL-c1717-25e88a6de101fef3328be043f07508c9324863aa2002cd6345de1f984472aa3c3
IEDL.DBID .~1
ISSN 2254-8874
IngestDate Thu Sep 26 17:54:11 EDT 2024
Sat Sep 28 08:22:59 EDT 2024
Fri Feb 23 02:31:50 EST 2024
IsPeerReviewed false
IsScholarly false
Issue 8
Keywords Prevalence
Clinical trials
Definition
Clinical research
Oncology
Equívoco terapéutico
Consentimiento informado
Ensayos clínicos
Investigación clínica
Definición
Prevalencia
Oncología
Placebo
Informed consent
Participants information sheet
Therapeutic misconception
Hoja de información para el participante
Language English
License Copyright © 2014 Elsevier España, S.L.U. All rights reserved.
LinkModel DirectLink
MergedId FETCHMERGED-LOGICAL-c1717-25e88a6de101fef3328be043f07508c9324863aa2002cd6345de1f984472aa3c3
PMID 24837147
PageCount 5
ParticipantIDs crossref_primary_10_1016_j_rceng_2014_03_006
pubmed_primary_24837147
elsevier_sciencedirect_doi_10_1016_j_rceng_2014_03_006
PublicationCentury 2000
PublicationDate November 2014
2014-Nov
2014-11-00
PublicationDateYYYYMMDD 2014-11-01
PublicationDate_xml – month: 11
  year: 2014
  text: November 2014
PublicationDecade 2010
PublicationPlace Spain
PublicationPlace_xml – name: Spain
PublicationTitle Revista clínica espanõla (English edition)
PublicationTitleAlternate Rev Clin Esp (Barc)
PublicationYear 2014
Publisher Elsevier España
Publisher_xml – name: Elsevier España
References Hernández, Serrano, Pérez (bib0135) 2013
Hoberman, Shaikh, Bhatnagar, Haralam, Kearney, Colborn (bib0120) 2013; 167
Pope, Tingey, Arnold, Hong, Ouimet, Krizova (bib0165) 2003; 30
Horstmann, McCabe, Grochow, Yamamoto, Rubinstein, Budd (bib0055) 2005; 352
Chou, O’Rourke (bib0155) 2012; 16
Sherber, Powe, Braunstein (bib0065) 2009; 30
Bertoli, Strusberg, Fierro, Ramos, Strusberg (bib0170) 2007; 28
National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (bib0025) 1979; 44
Ryan, Prictor, McLaughlin, Hill (bib0180) 2008; 1
Nishimura, Carey, Erwin, Tilburt, Murad, McCormick (bib0175) 2013; 14
Appelbaum, Anatchkova, Albert, Dunn, Lidz (bib0160) 2012; 9
Wendler, Krohman, Emanuel, Grady (bib0115) 2008; 168
Appelbaum, Roth, Lidz (bib0005) 1982; 5
(bib0035) 2001
Appelbaum, Roth, Lidz, Benson, Winslade (bib0010) 1987; 17
Cheung, Pond, Heslegrave, Enright, Potanina, Siu (bib0080) 2010; 33
The PLoS Medicine editors (bib0030) 2007; 4
Lidz, Appelbaum, Grisso, Renaud (bib0105) 2004; 58
Kimmelman (bib0150) 2007; 37
Asociación Médica Mundial (bib0020) 2014
Bergenmar, Molin, Wilking, Brandberg (bib0085) 2008; 44
Ordovás Baines (bib0110) 2008; 131
Pentz, White, Harvey, Farmer, Liu, Lewis (bib0060) 2012; 118
Horng, Emanuel, Wilfond, Rackoff, Martz, Grady (bib0070) 2002; 347
Hereu, Pérez, Fuentes, Vidal, Suñé, Arnau (bib0095) 2010; 31
Appelbaum, Lidz (bib0015) 2008
Appelbaum, Lidz, Grisso (bib0050) 2004; 26
Sammons, Atkinson, Choonara, Stephenson (bib0125) 2007; 7
Downing, Aminawung, Shah, Krumholz, Ross (bib0130) 2014; 311
Henderson, Churchill, Davis, Easter, Grady, Joffe (bib0045) 2007; 4
Joffe, Weekes (bib0145) 2002; 94
De Vries, Houtlosser, Wit, Engberts, Bresters, Kaspers (bib0140) 2011; 12
Horng, Grady (bib0040) 2003; 25
Jovell, Navarro (bib0090) 2013
Charuvastra, Marder (bib0100) 2008; 34
Dal-Ré, Carné (bib0185) 2006; 127
Kimmelman, Palmour (bib0075) 2005; 31
Horng (10.1016/j.rceng.2014.03.006_bib0040) 2003; 25
Bergenmar (10.1016/j.rceng.2014.03.006_bib0085) 2008; 44
Hernández (10.1016/j.rceng.2014.03.006_bib0135) 2013
(10.1016/j.rceng.2014.03.006_bib0035) 2001
Wendler (10.1016/j.rceng.2014.03.006_bib0115) 2008; 168
Appelbaum (10.1016/j.rceng.2014.03.006_bib0015) 2008
Jovell (10.1016/j.rceng.2014.03.006_bib0090) 2013
Pentz (10.1016/j.rceng.2014.03.006_bib0060) 2012; 118
Sammons (10.1016/j.rceng.2014.03.006_bib0125) 2007; 7
Kimmelman (10.1016/j.rceng.2014.03.006_bib0150) 2007; 37
Charuvastra (10.1016/j.rceng.2014.03.006_bib0100) 2008; 34
Kimmelman (10.1016/j.rceng.2014.03.006_bib0075) 2005; 31
Bertoli (10.1016/j.rceng.2014.03.006_bib0170) 2007; 28
Appelbaum (10.1016/j.rceng.2014.03.006_bib0005) 1982; 5
Hoberman (10.1016/j.rceng.2014.03.006_bib0120) 2013; 167
The PLoS Medicine editors (10.1016/j.rceng.2014.03.006_bib0030) 2007; 4
Horng (10.1016/j.rceng.2014.03.006_bib0070) 2002; 347
Sherber (10.1016/j.rceng.2014.03.006_bib0065) 2009; 30
Dal-Ré (10.1016/j.rceng.2014.03.006_bib0185) 2006; 127
Henderson (10.1016/j.rceng.2014.03.006_bib0045) 2007; 4
Appelbaum (10.1016/j.rceng.2014.03.006_bib0050) 2004; 26
Nishimura (10.1016/j.rceng.2014.03.006_bib0175) 2013; 14
Joffe (10.1016/j.rceng.2014.03.006_bib0145) 2002; 94
Pope (10.1016/j.rceng.2014.03.006_bib0165) 2003; 30
Appelbaum (10.1016/j.rceng.2014.03.006_bib0160) 2012; 9
Appelbaum (10.1016/j.rceng.2014.03.006_bib0010) 1987; 17
Horstmann (10.1016/j.rceng.2014.03.006_bib0055) 2005; 352
Hereu (10.1016/j.rceng.2014.03.006_bib0095) 2010; 31
Downing (10.1016/j.rceng.2014.03.006_bib0130) 2014; 311
Asociación Médica Mundial (10.1016/j.rceng.2014.03.006_bib0020) 2014
National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (10.1016/j.rceng.2014.03.006_bib0025) 1979; 44
De Vries (10.1016/j.rceng.2014.03.006_bib0140) 2011; 12
Lidz (10.1016/j.rceng.2014.03.006_bib0105) 2004; 58
Ordovás Baines (10.1016/j.rceng.2014.03.006_bib0110) 2008; 131
Chou (10.1016/j.rceng.2014.03.006_bib0155) 2012; 16
Ryan (10.1016/j.rceng.2014.03.006_bib0180) 2008; 1
Cheung (10.1016/j.rceng.2014.03.006_bib0080) 2010; 33
References_xml – volume: 37
  start-page: 36
  year: 2007
  end-page: 42
  ident: bib0150
  article-title: The therapeutic misconception at 25: treatment, research, and confusion
  publication-title: Hastings Cent Rep
  contributor:
    fullname: Kimmelman
– volume: 5
  start-page: 319
  year: 1982
  end-page: 329
  ident: bib0005
  article-title: The therapeutic misconception: informed consent in psychiatric research
  publication-title: Int J Law Psychiatry
  contributor:
    fullname: Lidz
– volume: 17
  start-page: 20
  year: 1987
  end-page: 24
  ident: bib0010
  article-title: False hopes and best data: consent to research and the therapeutic misconception
  publication-title: Hastings Cent Rep
  contributor:
    fullname: Winslade
– volume: 14
  start-page: 28
  year: 2013
  ident: bib0175
  article-title: Improving understanding in the research informed consent process: a systematic review of 54 interventions tested in randomized control trials
  publication-title: BMC Med Ethics
  contributor:
    fullname: McCormick
– volume: 167
  start-page: 561
  year: 2013
  end-page: 566
  ident: bib0120
  article-title: Factors that influence parental decisions to participate in clinical research: consenters vs nonconsenters
  publication-title: JAMA Pediatr
  contributor:
    fullname: Colborn
– volume: 7
  start-page: 12
  year: 2007
  ident: bib0125
  article-title: What motivates British parents to consent for research? A questionnaire study
  publication-title: BMC Pediatr
  contributor:
    fullname: Stephenson
– volume: 9
  start-page: 748
  year: 2012
  end-page: 761
  ident: bib0160
  article-title: Therapeutic misconception in research subjects: development and validation of a measure
  publication-title: Clin Trials
  contributor:
    fullname: Lidz
– start-page: 633
  year: 2008
  end-page: 644
  ident: bib0015
  article-title: The therapeutic misconception
  publication-title: The Oxford textbook of clinical research ethics
  contributor:
    fullname: Lidz
– volume: 31
  start-page: 209
  year: 2005
  end-page: 214
  ident: bib0075
  article-title: Therapeutic optimism in the consent forms of phase 1 gene transfer trials: an empirical analysis
  publication-title: J Med Ethics
  contributor:
    fullname: Palmour
– volume: 31
  start-page: 443
  year: 2010
  end-page: 446
  ident: bib0095
  article-title: Consent in clinical trials: what do patients know?
  publication-title: Contemp Clin Trials
  contributor:
    fullname: Arnau
– volume: 16
  start-page: 145
  year: 2012
  end-page: 153
  ident: bib0155
  article-title: Development and initial validation of the Therapeutic Misunderstanding Scale for use with clinical trials research participants
  publication-title: Aging Ment Health
  contributor:
    fullname: O’Rourke
– volume: 127
  start-page: 59
  year: 2006
  end-page: 65
  ident: bib0185
  article-title: ¿Los pacientes deben recibir una remuneración económica por su participación en ensayos clínicos terapéuticos?
  publication-title: Med Clin (Barc)
  contributor:
    fullname: Carné
– year: 2014
  ident: bib0020
  article-title: Code of Medical Ethics
  contributor:
    fullname: Asociación Médica Mundial
– volume: 30
  start-page: 227
  year: 2009
  end-page: 232
  ident: bib0065
  article-title: Personal physicians as study investigators: impact on patients’ willingness to participate in clinical trials
  publication-title: Contemp Clin Trials
  contributor:
    fullname: Braunstein
– volume: 25
  start-page: 11
  year: 2003
  end-page: 16
  ident: bib0040
  article-title: Misunderstanding in clinical research: distinguishing therapeutic misconception, therapeutic misestimation, and therapeutic optimism
  publication-title: IRB
  contributor:
    fullname: Grady
– volume: 131
  start-page: 422
  year: 2008
  end-page: 425
  ident: bib0110
  article-title: Estudio observacional y prospectivo del consentimiento informado de los pacientes en ensayos clínicos con medicamentos
  publication-title: Med Clin (Barc)
  contributor:
    fullname: Ordovás Baines
– volume: 12
  start-page: 18
  year: 2011
  ident: bib0140
  article-title: Ethical issues at the interface of clinical care and research practice in pediatric oncology: a narrative review of parents’ and physicians’ experiences
  publication-title: BMC Med Ethics
  contributor:
    fullname: Kaspers
– volume: 4
  start-page: e324
  year: 2007
  ident: bib0045
  article-title: Clinical trials and medical care: defining the therapeutic misconception
  publication-title: PLoS Med
  contributor:
    fullname: Joffe
– start-page: 139
  year: 2013
  end-page: 153
  ident: bib0090
  article-title: Qué esperan los pacientes cuando participan en los ensayos clínicos. Dilemas éticos y conflictos morales latentes
  publication-title: Luces y sombras en la investigación clínica
  contributor:
    fullname: Navarro
– volume: 30
  start-page: 815
  year: 2003
  end-page: 824
  ident: bib0165
  article-title: Are subjects satisfied with the informed consent process? A survey of research participants
  publication-title: J Rheumatol
  contributor:
    fullname: Krizova
– year: 2001
  ident: bib0035
  publication-title: Ethical and policy issues in international research: clinical trials in developing countries
– volume: 58
  start-page: 1689
  year: 2004
  end-page: 1697
  ident: bib0105
  article-title: Therapeutic misconception and the appreciation of risks in clinical trials
  publication-title: Soc Sci Med
  contributor:
    fullname: Renaud
– volume: 4
  start-page: e340
  year: 2007
  ident: bib0030
  article-title: How can we draw the line between clinical care and medical research
  publication-title: PLoS Med
  contributor:
    fullname: The PLoS Medicine editors
– volume: 1
  start-page: CD003717
  year: 2008
  ident: bib0180
  article-title: Audio-visual presentation of information for informed consent for participation in clinical trials
  publication-title: Cochrane Database Syst Rev
  contributor:
    fullname: Hill
– volume: 118
  start-page: 4571
  year: 2012
  end-page: 4578
  ident: bib0060
  article-title: Therapeutic misconception, misestimation, and optimism in participants enrolled in phase 1 trials
  publication-title: Cancer
  contributor:
    fullname: Lewis
– volume: 347
  start-page: 2134
  year: 2002
  end-page: 2140
  ident: bib0070
  article-title: Descriptions of benefits and risks in consent forms for phase 1 oncology trials
  publication-title: N Engl J Med
  contributor:
    fullname: Grady
– volume: 311
  start-page: 368
  year: 2014
  end-page: 377
  ident: bib0130
  article-title: Clinical trial evidence supporting FDA approval of novel therapeutic agents, 2005–2012
  publication-title: JAMA
  contributor:
    fullname: Ross
– volume: 44
  start-page: 2627
  year: 2008
  end-page: 2633
  ident: bib0085
  article-title: Knowledge and understanding among cancer patients consenting to participate in clinical trials
  publication-title: Eur J Cancer
  contributor:
    fullname: Brandberg
– volume: 94
  start-page: 1847
  year: 2002
  end-page: 1853
  ident: bib0145
  article-title: Views of american oncologists about the purposes of clinical trials
  publication-title: J Natl Cancer Inst
  contributor:
    fullname: Weekes
– volume: 352
  start-page: 895
  year: 2005
  end-page: 904
  ident: bib0055
  article-title: Risks and benefits of phase 1 oncology trials, 1991 through 2002
  publication-title: N Engl J Med
  contributor:
    fullname: Budd
– volume: 28
  start-page: 730
  year: 2007
  end-page: 736
  ident: bib0170
  article-title: Lack of correlation between satisfaction and knowledge in clinical trials participants: a pilot study
  publication-title: Contemp Clin Trials
  contributor:
    fullname: Strusberg
– volume: 44
  start-page: 23192
  year: 1979
  end-page: 23197
  ident: bib0025
  article-title: Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research, Report Of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research
  publication-title: Fed Reg
  contributor:
    fullname: National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research
– volume: 168
  start-page: 1294
  year: 2008
  end-page: 1299
  ident: bib0115
  article-title: Why patients continue to participate in clinical research
  publication-title: Arch Intern Med
  contributor:
    fullname: Grady
– volume: 34
  start-page: 193
  year: 2008
  end-page: 197
  ident: bib0100
  article-title: Unconscious emotional reasoning and the therapeutic misconception
  publication-title: J Med Ethics
  contributor:
    fullname: Marder
– volume: 26
  start-page: 1
  year: 2004
  end-page: 8
  ident: bib0050
  article-title: Therapeutic misconception in clinical research: frequency and risk factors
  publication-title: IRB
  contributor:
    fullname: Grisso
– start-page: 437
  year: 2013
  end-page: 461
  ident: bib0135
  article-title: El futuro de los ensayos clínicos con medicamentos. El sentido y las razones
  publication-title: Luces y sombras en la investigación clínica
  contributor:
    fullname: Pérez
– volume: 33
  start-page: 387
  year: 2010
  end-page: 392
  ident: bib0080
  article-title: The contents and readability of informed consent forms for oncology clinical trials
  publication-title: Am J Clin Oncol
  contributor:
    fullname: Siu
– volume: 7
  start-page: 12
  year: 2007
  ident: 10.1016/j.rceng.2014.03.006_bib0125
  article-title: What motivates British parents to consent for research? A questionnaire study
  publication-title: BMC Pediatr
  doi: 10.1186/1471-2431-7-12
  contributor:
    fullname: Sammons
– volume: 17
  start-page: 20
  year: 1987
  ident: 10.1016/j.rceng.2014.03.006_bib0010
  article-title: False hopes and best data: consent to research and the therapeutic misconception
  publication-title: Hastings Cent Rep
  doi: 10.2307/3562038
  contributor:
    fullname: Appelbaum
– volume: 25
  start-page: 11
  year: 2003
  ident: 10.1016/j.rceng.2014.03.006_bib0040
  article-title: Misunderstanding in clinical research: distinguishing therapeutic misconception, therapeutic misestimation, and therapeutic optimism
  publication-title: IRB
  doi: 10.2307/3564408
  contributor:
    fullname: Horng
– volume: 26
  start-page: 1
  year: 2004
  ident: 10.1016/j.rceng.2014.03.006_bib0050
  article-title: Therapeutic misconception in clinical research: frequency and risk factors
  publication-title: IRB
  doi: 10.2307/3564231
  contributor:
    fullname: Appelbaum
– volume: 30
  start-page: 815
  year: 2003
  ident: 10.1016/j.rceng.2014.03.006_bib0165
  article-title: Are subjects satisfied with the informed consent process? A survey of research participants
  publication-title: J Rheumatol
  contributor:
    fullname: Pope
– volume: 127
  start-page: 59
  year: 2006
  ident: 10.1016/j.rceng.2014.03.006_bib0185
  article-title: ¿Los pacientes deben recibir una remuneración económica por su participación en ensayos clínicos terapéuticos?
  publication-title: Med Clin (Barc)
  doi: 10.1157/13089991
  contributor:
    fullname: Dal-Ré
– volume: 31
  start-page: 209
  year: 2005
  ident: 10.1016/j.rceng.2014.03.006_bib0075
  article-title: Therapeutic optimism in the consent forms of phase 1 gene transfer trials: an empirical analysis
  publication-title: J Med Ethics
  doi: 10.1136/jme.2003.006247
  contributor:
    fullname: Kimmelman
– volume: 14
  start-page: 28
  year: 2013
  ident: 10.1016/j.rceng.2014.03.006_bib0175
  article-title: Improving understanding in the research informed consent process: a systematic review of 54 interventions tested in randomized control trials
  publication-title: BMC Med Ethics
  doi: 10.1186/1472-6939-14-28
  contributor:
    fullname: Nishimura
– volume: 44
  start-page: 2627
  year: 2008
  ident: 10.1016/j.rceng.2014.03.006_bib0085
  article-title: Knowledge and understanding among cancer patients consenting to participate in clinical trials
  publication-title: Eur J Cancer
  doi: 10.1016/j.ejca.2008.08.013
  contributor:
    fullname: Bergenmar
– volume: 167
  start-page: 561
  year: 2013
  ident: 10.1016/j.rceng.2014.03.006_bib0120
  article-title: Factors that influence parental decisions to participate in clinical research: consenters vs nonconsenters
  publication-title: JAMA Pediatr
  doi: 10.1001/jamapediatrics.2013.1050
  contributor:
    fullname: Hoberman
– year: 2001
  ident: 10.1016/j.rceng.2014.03.006_bib0035
  publication-title: Ethical and policy issues in international research: clinical trials in developing countries
– volume: 33
  start-page: 387
  year: 2010
  ident: 10.1016/j.rceng.2014.03.006_bib0080
  article-title: The contents and readability of informed consent forms for oncology clinical trials
  publication-title: Am J Clin Oncol
  doi: 10.1097/COC.0b013e3181b20641
  contributor:
    fullname: Cheung
– volume: 16
  start-page: 145
  year: 2012
  ident: 10.1016/j.rceng.2014.03.006_bib0155
  article-title: Development and initial validation of the Therapeutic Misunderstanding Scale for use with clinical trials research participants
  publication-title: Aging Ment Health
  doi: 10.1080/13607863.2011.602962
  contributor:
    fullname: Chou
– volume: 30
  start-page: 227
  year: 2009
  ident: 10.1016/j.rceng.2014.03.006_bib0065
  article-title: Personal physicians as study investigators: impact on patients’ willingness to participate in clinical trials
  publication-title: Contemp Clin Trials
  doi: 10.1016/j.cct.2009.01.002
  contributor:
    fullname: Sherber
– volume: 34
  start-page: 193
  year: 2008
  ident: 10.1016/j.rceng.2014.03.006_bib0100
  article-title: Unconscious emotional reasoning and the therapeutic misconception
  publication-title: J Med Ethics
  doi: 10.1136/jme.2006.018960
  contributor:
    fullname: Charuvastra
– volume: 5
  start-page: 319
  year: 1982
  ident: 10.1016/j.rceng.2014.03.006_bib0005
  article-title: The therapeutic misconception: informed consent in psychiatric research
  publication-title: Int J Law Psychiatry
  doi: 10.1016/0160-2527(82)90026-7
  contributor:
    fullname: Appelbaum
– volume: 9
  start-page: 748
  year: 2012
  ident: 10.1016/j.rceng.2014.03.006_bib0160
  article-title: Therapeutic misconception in research subjects: development and validation of a measure
  publication-title: Clin Trials
  doi: 10.1177/1740774512456455
  contributor:
    fullname: Appelbaum
– volume: 28
  start-page: 730
  year: 2007
  ident: 10.1016/j.rceng.2014.03.006_bib0170
  article-title: Lack of correlation between satisfaction and knowledge in clinical trials participants: a pilot study
  publication-title: Contemp Clin Trials
  doi: 10.1016/j.cct.2007.04.005
  contributor:
    fullname: Bertoli
– volume: 168
  start-page: 1294
  year: 2008
  ident: 10.1016/j.rceng.2014.03.006_bib0115
  article-title: Why patients continue to participate in clinical research
  publication-title: Arch Intern Med
  doi: 10.1001/archinte.168.12.1294
  contributor:
    fullname: Wendler
– volume: 12
  start-page: 18
  year: 2011
  ident: 10.1016/j.rceng.2014.03.006_bib0140
  article-title: Ethical issues at the interface of clinical care and research practice in pediatric oncology: a narrative review of parents’ and physicians’ experiences
  publication-title: BMC Med Ethics
  doi: 10.1186/1472-6939-12-18
  contributor:
    fullname: De Vries
– start-page: 139
  year: 2013
  ident: 10.1016/j.rceng.2014.03.006_bib0090
  article-title: Qué esperan los pacientes cuando participan en los ensayos clínicos. Dilemas éticos y conflictos morales latentes
  contributor:
    fullname: Jovell
– volume: 131
  start-page: 422
  year: 2008
  ident: 10.1016/j.rceng.2014.03.006_bib0110
  article-title: Estudio observacional y prospectivo del consentimiento informado de los pacientes en ensayos clínicos con medicamentos
  publication-title: Med Clin (Barc)
  doi: 10.1157/13126218
  contributor:
    fullname: Ordovás Baines
– volume: 58
  start-page: 1689
  year: 2004
  ident: 10.1016/j.rceng.2014.03.006_bib0105
  article-title: Therapeutic misconception and the appreciation of risks in clinical trials
  publication-title: Soc Sci Med
  doi: 10.1016/S0277-9536(03)00338-1
  contributor:
    fullname: Lidz
– start-page: 437
  year: 2013
  ident: 10.1016/j.rceng.2014.03.006_bib0135
  article-title: El futuro de los ensayos clínicos con medicamentos. El sentido y las razones
  contributor:
    fullname: Hernández
– volume: 347
  start-page: 2134
  year: 2002
  ident: 10.1016/j.rceng.2014.03.006_bib0070
  article-title: Descriptions of benefits and risks in consent forms for phase 1 oncology trials
  publication-title: N Engl J Med
  doi: 10.1056/NEJMsa021182
  contributor:
    fullname: Horng
– volume: 311
  start-page: 368
  year: 2014
  ident: 10.1016/j.rceng.2014.03.006_bib0130
  article-title: Clinical trial evidence supporting FDA approval of novel therapeutic agents, 2005–2012
  publication-title: JAMA
  doi: 10.1001/jama.2013.282034
  contributor:
    fullname: Downing
– volume: 1
  start-page: CD003717
  year: 2008
  ident: 10.1016/j.rceng.2014.03.006_bib0180
  article-title: Audio-visual presentation of information for informed consent for participation in clinical trials
  publication-title: Cochrane Database Syst Rev
  contributor:
    fullname: Ryan
– volume: 352
  start-page: 895
  year: 2005
  ident: 10.1016/j.rceng.2014.03.006_bib0055
  article-title: Risks and benefits of phase 1 oncology trials, 1991 through 2002
  publication-title: N Engl J Med
  doi: 10.1056/NEJMsa042220
  contributor:
    fullname: Horstmann
– start-page: 633
  year: 2008
  ident: 10.1016/j.rceng.2014.03.006_bib0015
  article-title: The therapeutic misconception
  contributor:
    fullname: Appelbaum
– volume: 44
  start-page: 23192
  year: 1979
  ident: 10.1016/j.rceng.2014.03.006_bib0025
  article-title: Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research, Report Of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research
  publication-title: Fed Reg
  contributor:
    fullname: National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research
– volume: 118
  start-page: 4571
  year: 2012
  ident: 10.1016/j.rceng.2014.03.006_bib0060
  article-title: Therapeutic misconception, misestimation, and optimism in participants enrolled in phase 1 trials
  publication-title: Cancer
  doi: 10.1002/cncr.27397
  contributor:
    fullname: Pentz
– volume: 94
  start-page: 1847
  year: 2002
  ident: 10.1016/j.rceng.2014.03.006_bib0145
  article-title: Views of american oncologists about the purposes of clinical trials
  publication-title: J Natl Cancer Inst
  doi: 10.1093/jnci/94.24.1847
  contributor:
    fullname: Joffe
– year: 2014
  ident: 10.1016/j.rceng.2014.03.006_bib0020
  contributor:
    fullname: Asociación Médica Mundial
– volume: 4
  start-page: e340
  year: 2007
  ident: 10.1016/j.rceng.2014.03.006_bib0030
  article-title: How can we draw the line between clinical care and medical research
  publication-title: PLoS Med
  doi: 10.1371/journal.pmed.0040340
  contributor:
    fullname: The PLoS Medicine editors
– volume: 37
  start-page: 36
  year: 2007
  ident: 10.1016/j.rceng.2014.03.006_bib0150
  article-title: The therapeutic misconception at 25: treatment, research, and confusion
  publication-title: Hastings Cent Rep
  doi: 10.1353/hcr.2007.0092
  contributor:
    fullname: Kimmelman
– volume: 31
  start-page: 443
  year: 2010
  ident: 10.1016/j.rceng.2014.03.006_bib0095
  article-title: Consent in clinical trials: what do patients know?
  publication-title: Contemp Clin Trials
  doi: 10.1016/j.cct.2010.05.004
  contributor:
    fullname: Hereu
– volume: 4
  start-page: e324
  year: 2007
  ident: 10.1016/j.rceng.2014.03.006_bib0045
  article-title: Clinical trials and medical care: defining the therapeutic misconception
  publication-title: PLoS Med
  doi: 10.1371/journal.pmed.0040324
  contributor:
    fullname: Henderson
SSID ssj0001219560
Score 1.5904212
Snippet A clinical trial seeks information for the benefit of future patients and not necessarily for those who participate in the study. However, there are patients...
SourceID crossref
pubmed
elsevier
SourceType Aggregation Database
Index Database
Publisher
StartPage 470
SubjectTerms Clinical research
Clinical trials
Consentimiento informado
Definición
Definition
Ensayos clínicos
Equívoco terapéutico
Hoja de información para el participante
Informed consent
Investigación clínica
Oncology
Oncología
Participants information sheet
Placebo
Prevalence
Prevalencia
Therapeutic misconception
Title Therapeutic misconception in clinical trials: Fighting against it and living with it
URI https://dx.doi.org/10.1016/j.rceng.2014.03.006
https://www.ncbi.nlm.nih.gov/pubmed/24837147
Volume 214
hasFullText 1
inHoldings 1
isFullTextHit
isPrint
link http://utb.summon.serialssolutions.com/2.0.0/link/0/eLvHCXMwnV07T8MwELaqIiEWxJvyqDwwYho_kjhsVUVVQO1CK3WLHMepglCoSln57dzlAWUBiTGW7SSfT3fn831nQq64DURiPcei0FmmQilY5ALLLPgaJgqt8FIkOI8nwWimHub-vEUGDRcG0ypr3V_p9FJb1y29Gs3eMs97TyCJIH1gERUashArfiowRiDTNx98I86CjDgMtWB_hgOa4kNlmtfKumKBKV6qKnYa_GGgNqzPcI_s1m4j7Vdftk9arjgg2-P6YPyQTKffPCoKS2crNiKATvOCNvRHWt7R8XZLh7glB6NFzcLk4CDSfE1NkdKXHOMLFIOz0HREZsO76WDE6gsTmOWwLWPCd1qbIHXwb5nLpBQ6cZ6SGfoF2oKrpnQgjcHEDJsGUvnQNYu0UqEwRlp5TNrFa-FOCYUV5E6nScT9RDkhdGYTx3liYX6nfNMh1w1K8bKqixE3CWPPcQlqjKDGnowB1A4JGiTjH8sbg-b-feBJhfvXWwTWwOcqPPvvlOdkB58qQuEFaa9X7-4SPIt10i1Fp0u2-vePo8kn1gvMBg
link.rule.ids 315,786,790,4521,24144,27957,27958,45620,45714
linkProvider Elsevier
linkToHtml http://utb.summon.serialssolutions.com/2.0.0/link/0/eLvHCXMwnV1LT8MwDLbGJgEXxJvxzIEj1dokfXGbJqaOPS500m5RmqaoCJVpjP-P0weMC0hc0zptv1i24_pzAG4d5dFE2doKfa0s7jNqhdpTlsJYQ4a-onZqCM7TmRfN-ePCXbRg0HBhTFllbfsrm15a63qkV6PZW-Z57wk1EbUPPSI3jsxnW9Dhru_wNnT6o3E020i1GFKcybYYEcvINP2HykqvldLFs6ny4lW_U-8PH7XhgIb7sFdHjqRfvdwBtHRxCNvT-t_4EcTxN5WK4OqpipCIuJO8IA0DkpTHdLzfk6HZlaPfIvJZ5hgjknxNZJGS19ykGIjJz-LQMcyHD_EgsuozEyzl4M7Moq4OAumlGr8t0xljNEi0zVlmQoNAYbTGA49JaWozVOox7uKtWRhw7lMpmWIn0C7eCn0GBBfR0UGahI6bcE1pkKlEO06icH7NXdmFuwYlsaxaY4imZuxFlKAKA6qwmUBQu-A1SIofKyzQeP8ueFrh_vUUatrgO9w__--UN7ATxdOJmIxm4wvYNVcqfuEltNerD32FgcY6ua4V6RP2n868
openUrl ctx_ver=Z39.88-2004&ctx_enc=info%3Aofi%2Fenc%3AUTF-8&rfr_id=info%3Asid%2Fsummon.serialssolutions.com&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=Therapeutic+misconception+in+clinical+trials%3A+Fighting+against+it+and+living+with+it&rft.jtitle=Revista+cl%C3%ADnica+espan%C3%B5la+%28English+edition%29&rft.au=Dal-R%C3%A9%2C+R.&rft.au=Morell%2C+F.&rft.au=Tejedor%2C+J.C.&rft.au=Gracia%2C+D.&rft.date=2014-11-01&rft.pub=Elsevier+Espa%C3%B1a&rft.issn=2254-8874&rft.eissn=2254-8874&rft.volume=214&rft.issue=8&rft.spage=470&rft.epage=474&rft_id=info:doi/10.1016%2Fj.rceng.2014.03.006&rft.externalDocID=S2254887414000873
thumbnail_l http://covers-cdn.summon.serialssolutions.com/index.aspx?isbn=/lc.gif&issn=2254-8874&client=summon
thumbnail_m http://covers-cdn.summon.serialssolutions.com/index.aspx?isbn=/mc.gif&issn=2254-8874&client=summon
thumbnail_s http://covers-cdn.summon.serialssolutions.com/index.aspx?isbn=/sc.gif&issn=2254-8874&client=summon