Methodological choices for the clinical development of medical devices

Alain Bernard,1 Michel Vaneau,2 Isabelle Fournel,3 Hubert Galmiche,2 Patrice Nony,4,5 Jean Michel Dubernard6 1Department of Thoracic Surgery CHU Bocage, Dijon, France; 2Department for Assessment of Medical Devices, HAS (French National Authority of Health), Saint-Denis La Plaine, France; 3Centre of...

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Autores principales:	Bernard A, Vaneau M, Fournel I, Galmiche H, Nony P, Dubernard JM
Formato:	article
Lenguaje:	EN
Publicado:	Dove Medical Press 2014
Materias:	Medical technology R855-855.5
Acceso en línea:	https://doaj.org/article/c7b96548a0974eb899f43d82e267a3af
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spelling	oai:doaj.org-article:c7b96548a0974eb899f43d82e267a3af2021-12-02T07:15:39ZMethodological choices for the clinical development of medical devices1179-1470https://doaj.org/article/c7b96548a0974eb899f43d82e267a3af2014-09-01T00:00:00Zhttp://www.dovepress.com/methodological-choices-for-the-clinical-development-of-medical-devices-peer-reviewed-article-MDERhttps://doaj.org/toc/1179-1470 Alain Bernard,1 Michel Vaneau,2 Isabelle Fournel,3 Hubert Galmiche,2 Patrice Nony,4,5 Jean Michel Dubernard6 1Department of Thoracic Surgery CHU Bocage, Dijon, France; 2Department for Assessment of Medical Devices, HAS (French National Authority of Health), Saint-Denis La Plaine, France; 3Centre of Epidemiology of the Populations, Burgundy University, Dijon, France; 4Department of Clinical Pharmacology, Lyon University CNRS, Lyon, France; 5Laboratory of Biometry and Biology, CNRS, Lyon, France; 6HAS Board (French National Authority of Health), Saint-Denis La Plaine, France Abstract: Clinical evidence available for the assessment of medical devices (MDs) is frequently insufficient. New MDs should be subjected to high quality clinical studies to demonstrate their benefit to patients. The randomized controlled trial (RCT) is the study design reaching the highest level of evidence in order to demonstrate the efficacy of a new MD. However, the clinical context of some MDs makes it difficult to carry out a conventional RCT. The objectives of this review are to present problems related to conducting conventional RCTs and to identify other experimental designs, their limitations, and their applications. A systematic literature search was conducted for the period January 2000 to July 2012 by searching medical bibliographic databases. Problems related to conducting conventional RCTs of MDs were identified: timing the assessment, eligible population and recruitment, acceptability, blinding, choice of comparator group, and learning curve. Other types of experimental designs have been described. Zelen's design trials and randomized consent design trials facilitate the recruitment of patients, but can cause ethical problems to arise. Expertise-based RCTs involve randomization to a team that specializes in a given intervention. Sometimes, the feasibility of an expertise-based randomized trial may be greater than that of a conventional trial. Cross-over trials reduce the number of patients, but are not applicable when a learning curve is required. Sequential trials have the advantage of allowing a trial to be stopped early depending on the results of first inclusions, but they require an independent committee. Bayesian methods combine existing information with information from the ongoing trial. These methods are particularly useful in situations where the number of subjects is small. The disadvantage is the risk of including erroneous prior information. Other types of experimental designs exist when conventional trials cannot always be applied to the clinical development of MDs. Keywords: medical device, randomized controlled trials, assessment, clinical developmentBernard AVaneau MFournel IGalmiche HNony PDubernard JMDove Medical PressarticleMedical technologyR855-855.5ENMedical Devices: Evidence and Research, Vol 2014, Iss default, Pp 325-334 (2014)
institution	DOAJ
collection	DOAJ
language	EN
topic	Medical technology R855-855.5
spellingShingle	Medical technology R855-855.5 Bernard A Vaneau M Fournel I Galmiche H Nony P Dubernard JM Methodological choices for the clinical development of medical devices
description	Alain Bernard,1 Michel Vaneau,2 Isabelle Fournel,3 Hubert Galmiche,2 Patrice Nony,4,5 Jean Michel Dubernard6 1Department of Thoracic Surgery CHU Bocage, Dijon, France; 2Department for Assessment of Medical Devices, HAS (French National Authority of Health), Saint-Denis La Plaine, France; 3Centre of Epidemiology of the Populations, Burgundy University, Dijon, France; 4Department of Clinical Pharmacology, Lyon University CNRS, Lyon, France; 5Laboratory of Biometry and Biology, CNRS, Lyon, France; 6HAS Board (French National Authority of Health), Saint-Denis La Plaine, France Abstract: Clinical evidence available for the assessment of medical devices (MDs) is frequently insufficient. New MDs should be subjected to high quality clinical studies to demonstrate their benefit to patients. The randomized controlled trial (RCT) is the study design reaching the highest level of evidence in order to demonstrate the efficacy of a new MD. However, the clinical context of some MDs makes it difficult to carry out a conventional RCT. The objectives of this review are to present problems related to conducting conventional RCTs and to identify other experimental designs, their limitations, and their applications. A systematic literature search was conducted for the period January 2000 to July 2012 by searching medical bibliographic databases. Problems related to conducting conventional RCTs of MDs were identified: timing the assessment, eligible population and recruitment, acceptability, blinding, choice of comparator group, and learning curve. Other types of experimental designs have been described. Zelen's design trials and randomized consent design trials facilitate the recruitment of patients, but can cause ethical problems to arise. Expertise-based RCTs involve randomization to a team that specializes in a given intervention. Sometimes, the feasibility of an expertise-based randomized trial may be greater than that of a conventional trial. Cross-over trials reduce the number of patients, but are not applicable when a learning curve is required. Sequential trials have the advantage of allowing a trial to be stopped early depending on the results of first inclusions, but they require an independent committee. Bayesian methods combine existing information with information from the ongoing trial. These methods are particularly useful in situations where the number of subjects is small. The disadvantage is the risk of including erroneous prior information. Other types of experimental designs exist when conventional trials cannot always be applied to the clinical development of MDs. Keywords: medical device, randomized controlled trials, assessment, clinical development
format	article
author	Bernard A Vaneau M Fournel I Galmiche H Nony P Dubernard JM
author_facet	Bernard A Vaneau M Fournel I Galmiche H Nony P Dubernard JM
author_sort	Bernard A
title	Methodological choices for the clinical development of medical devices
title_short	Methodological choices for the clinical development of medical devices
title_full	Methodological choices for the clinical development of medical devices
title_fullStr	Methodological choices for the clinical development of medical devices
title_full_unstemmed	Methodological choices for the clinical development of medical devices
title_sort	methodological choices for the clinical development of medical devices
publisher	Dove Medical Press
publishDate	2014
url	https://doaj.org/article/c7b96548a0974eb899f43d82e267a3af
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Methodological choices for the clinical development of medical devices

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