Methodological quality and reporting of ethical requirements in clinical trials
Objectives—To assess the relationship between the approval of trials by a research ethics committee (REC) and the fact that informed consent from participants (ICP) was obtained, with the quality of study design and methods. Design—Systematic review using a standardised checklist. Main measures—Met...
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| Format: | info:eu-repo/semantics/article |
| Language: | eng |
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BMJ Publishing Group
2010
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| Online Access: | https://hdl.handle.net/10171/6971 |
| _version_ | 1793400166247563264 |
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| author | Ruiz-Canela, M. (Miguel) Irala, J. (Jokin) de Martinez-Gonzalez, M.A. (Miguel Ángel) Gomez-Gracia, E. (Enrique) Fernandez-Crehuet, J. (Joaquín) |
| author_facet | Ruiz-Canela, M. (Miguel) Irala, J. (Jokin) de Martinez-Gonzalez, M.A. (Miguel Ángel) Gomez-Gracia, E. (Enrique) Fernandez-Crehuet, J. (Joaquín) |
| author_sort | Ruiz-Canela, M. (Miguel) |
| collection | DSpace |
| description | Objectives—To assess the relationship between the approval of trials by a research ethics committee (REC) and the fact that informed consent from participants (ICP) was obtained, with the quality of study design and methods. Design—Systematic review using a standardised checklist.
Main measures—Methodological and ethical issues of all trials published between 1993 and 1995 in the New England Journal of Medicine, the Lancet, the Journal of the American Medical Association and the British Medical Journal were studied. In addition, clinical trials conducted in Spain and
published by at least one Spanish author during the same period in any other journal were also included.
Results—We studied the published articles of 767 trials and found the following indicators of lower methodological quality to be independent predictors for failure to disclose REC approval or ICP: absence of
concealment of allocation, lack of justification for unblinded trials, not using a treatment for the patients
in the control group, absent information on statistical methods, not including sample size estimation, not establishing the rules to stop the trial, and omitting the
presentation of a baseline comparison of groups Conclusion—Trials of higher methodological and scientific quality were more likely to provide information about their ethical aspects. |
| format | info:eu-repo/semantics/article |
| id | oai:dadun.unav.edu:10171-6971 |
| institution | Universidad de Navarra |
| language | eng |
| publishDate | 2010 |
| publisher | BMJ Publishing Group |
| record_format | dspace |
| spelling | oai:dadun.unav.edu:10171-69712022-06-29T09:41:38Z Methodological quality and reporting of ethical requirements in clinical trials Ruiz-Canela, M. (Miguel) Irala, J. (Jokin) de Martinez-Gonzalez, M.A. (Miguel Ángel) Gomez-Gracia, E. (Enrique) Fernandez-Crehuet, J. (Joaquín) Materias Investigacion::Ciencias de la Salud::Enseñanza médica, formación e investigación Objectives—To assess the relationship between the approval of trials by a research ethics committee (REC) and the fact that informed consent from participants (ICP) was obtained, with the quality of study design and methods. Design—Systematic review using a standardised checklist. Main measures—Methodological and ethical issues of all trials published between 1993 and 1995 in the New England Journal of Medicine, the Lancet, the Journal of the American Medical Association and the British Medical Journal were studied. In addition, clinical trials conducted in Spain and published by at least one Spanish author during the same period in any other journal were also included. Results—We studied the published articles of 767 trials and found the following indicators of lower methodological quality to be independent predictors for failure to disclose REC approval or ICP: absence of concealment of allocation, lack of justification for unblinded trials, not using a treatment for the patients in the control group, absent information on statistical methods, not including sample size estimation, not establishing the rules to stop the trial, and omitting the presentation of a baseline comparison of groups Conclusion—Trials of higher methodological and scientific quality were more likely to provide information about their ethical aspects. 2010-04-28T07:56:49Z 2010-04-28T07:56:49Z 2001 info:eu-repo/semantics/article https://hdl.handle.net/10171/6971 eng http://jme.bmj.com/content/27/3/172.full info:eu-repo/semantics/openAccess application/pdf BMJ Publishing Group |
| spellingShingle | Materias Investigacion::Ciencias de la Salud::Enseñanza médica, formación e investigación Ruiz-Canela, M. (Miguel) Irala, J. (Jokin) de Martinez-Gonzalez, M.A. (Miguel Ángel) Gomez-Gracia, E. (Enrique) Fernandez-Crehuet, J. (Joaquín) Methodological quality and reporting of ethical requirements in clinical trials |
| title | Methodological quality and reporting of ethical requirements in clinical trials |
| title_full | Methodological quality and reporting of ethical requirements in clinical trials |
| title_fullStr | Methodological quality and reporting of ethical requirements in clinical trials |
| title_full_unstemmed | Methodological quality and reporting of ethical requirements in clinical trials |
| title_short | Methodological quality and reporting of ethical requirements in clinical trials |
| title_sort | methodological quality and reporting of ethical requirements in clinical trials |
| topic | Materias Investigacion::Ciencias de la Salud::Enseñanza médica, formación e investigación |
| url | https://hdl.handle.net/10171/6971 |
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