Specific barriers to the conduct of randomised clinical trials on medical devices
Abstract Background Medical devices play an important role in the diagnosis, prevention, treatment and care of diseases. However, compared to pharmaceuticals, there is no rigorous formal regulation for demonstration of benefits and exclusion of harms to patients. The medical device industry argues t...
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| Format: | Article |
| Language: | English |
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BMC
2017-09-01
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| Series: | Trials |
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| Online Access: | http://link.springer.com/article/10.1186/s13063-017-2168-0 |
| _version_ | 1828476685247315968 |
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| author | Edmund A. M. Neugebauer Ana Rath Sunya-Lee Antoine Michaela Eikermann Doerthe Seidel Carsten Koenen Esther Jacobs Dawid Pieper Martine Laville Séverine Pitel Cecilia Martinho Snezana Djurisic Jacques Demotes-Mainard Christine Kubiak Vittorio Bertele Janus C. Jakobsen Silvio Garattini Christian Gluud |
| author_facet | Edmund A. M. Neugebauer Ana Rath Sunya-Lee Antoine Michaela Eikermann Doerthe Seidel Carsten Koenen Esther Jacobs Dawid Pieper Martine Laville Séverine Pitel Cecilia Martinho Snezana Djurisic Jacques Demotes-Mainard Christine Kubiak Vittorio Bertele Janus C. Jakobsen Silvio Garattini Christian Gluud |
| author_sort | Edmund A. M. Neugebauer |
| collection | DOAJ |
| description | Abstract Background Medical devices play an important role in the diagnosis, prevention, treatment and care of diseases. However, compared to pharmaceuticals, there is no rigorous formal regulation for demonstration of benefits and exclusion of harms to patients. The medical device industry argues that the classical evidence hierarchy cannot be applied for medical devices, as randomised clinical trials are impossible to perform. This article aims to identify the barriers for randomised clinical trials on medical devices. Methods Systematic literature searches without meta-analysis and internal European Clinical Research Infrastructure Network (ECRIN) communications taking place during face-to-face meetings and telephone conferences from 2013 to 2017 within the context of the ECRIN Integrating Activity (ECRIN-IA) project. Results In addition to the barriers that exist for all trials, we identified three major barriers for randomised clinical trials on medical devices, namely: (1) randomisation, including timing of assessment, acceptability, blinding, choice of the comparator group and considerations on the learning curve; (2) difficulties in determining appropriate outcomes; and (3) the lack of scientific advice, regulations and transparency. Conclusions The present review offers potential solutions to break down the barriers identified, and argues for applying the randomised clinical trial design when assessing the benefits and harms of medical devices. |
| first_indexed | 2024-12-11T06:32:08Z |
| format | Article |
| id | doaj.art-789d713ad1c644c6b9323d8a1747ace3 |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-12-11T06:32:08Z |
| publishDate | 2017-09-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-789d713ad1c644c6b9323d8a1747ace32022-12-22T01:17:28ZengBMCTrials1745-62152017-09-0118111010.1186/s13063-017-2168-0Specific barriers to the conduct of randomised clinical trials on medical devicesEdmund A. M. Neugebauer0Ana Rath1Sunya-Lee Antoine2Michaela Eikermann3Doerthe Seidel4Carsten Koenen5Esther Jacobs6Dawid Pieper7Martine Laville8Séverine Pitel9Cecilia Martinho10Snezana Djurisic11Jacques Demotes-Mainard12Christine Kubiak13Vittorio Bertele14Janus C. Jakobsen15Silvio Garattini16Christian Gluud17Brandenburg Medical School Theodor Fontane & Health Services Research Witten/Herdecke UniversityOrphanet, Institut National de la Santé et de la Recherche Médicale (INSERM)Institute for Research in Operative Medicine, Witten/Herdecke UniversityInstitute for Research in Operative Medicine, Witten/Herdecke UniversityInstitute for Research in Operative Medicine, Witten/Herdecke UniversityInstitute for Research in Operative Medicine, Witten/Herdecke UniversityInstitute for Research in Operative Medicine, Witten/Herdecke UniversityInstitute for Research in Operative Medicine, Witten/Herdecke UniversityCentre de Recherche en Nutrition Humaine Rhone-Alpes, Université de Lyon 1, Hospices Civils de Lyon, Groupement Hospitaler SudQUALISSIMAAIBILICopenhagen Trial Unit, Centre for Clinical Intervention Research, Rigshospitalet, Copenhagen University HospitalEuropean Clinical Research Infrastructure Network (ECRIN)European Clinical Research Infrastructure Network (ECRIN)IRCCS Istituto di Ricerche Farmacologiche Mario NegriCopenhagen Trial Unit, Centre for Clinical Intervention Research, Rigshospitalet, Copenhagen University HospitalIRCCS Istituto di Ricerche Farmacologiche Mario NegriCopenhagen Trial Unit, Centre for Clinical Intervention Research, Rigshospitalet, Copenhagen University HospitalAbstract Background Medical devices play an important role in the diagnosis, prevention, treatment and care of diseases. However, compared to pharmaceuticals, there is no rigorous formal regulation for demonstration of benefits and exclusion of harms to patients. The medical device industry argues that the classical evidence hierarchy cannot be applied for medical devices, as randomised clinical trials are impossible to perform. This article aims to identify the barriers for randomised clinical trials on medical devices. Methods Systematic literature searches without meta-analysis and internal European Clinical Research Infrastructure Network (ECRIN) communications taking place during face-to-face meetings and telephone conferences from 2013 to 2017 within the context of the ECRIN Integrating Activity (ECRIN-IA) project. Results In addition to the barriers that exist for all trials, we identified three major barriers for randomised clinical trials on medical devices, namely: (1) randomisation, including timing of assessment, acceptability, blinding, choice of the comparator group and considerations on the learning curve; (2) difficulties in determining appropriate outcomes; and (3) the lack of scientific advice, regulations and transparency. Conclusions The present review offers potential solutions to break down the barriers identified, and argues for applying the randomised clinical trial design when assessing the benefits and harms of medical devices.http://link.springer.com/article/10.1186/s13063-017-2168-0Randomised clinical trialsEvidence-based clinical practiceEvidence-based medicineAssessmentSpecific barriersMedical devices |
| spellingShingle | Edmund A. M. Neugebauer Ana Rath Sunya-Lee Antoine Michaela Eikermann Doerthe Seidel Carsten Koenen Esther Jacobs Dawid Pieper Martine Laville Séverine Pitel Cecilia Martinho Snezana Djurisic Jacques Demotes-Mainard Christine Kubiak Vittorio Bertele Janus C. Jakobsen Silvio Garattini Christian Gluud Specific barriers to the conduct of randomised clinical trials on medical devices Trials Randomised clinical trials Evidence-based clinical practice Evidence-based medicine Assessment Specific barriers Medical devices |
| title | Specific barriers to the conduct of randomised clinical trials on medical devices |
| title_full | Specific barriers to the conduct of randomised clinical trials on medical devices |
| title_fullStr | Specific barriers to the conduct of randomised clinical trials on medical devices |
| title_full_unstemmed | Specific barriers to the conduct of randomised clinical trials on medical devices |
| title_short | Specific barriers to the conduct of randomised clinical trials on medical devices |
| title_sort | specific barriers to the conduct of randomised clinical trials on medical devices |
| topic | Randomised clinical trials Evidence-based clinical practice Evidence-based medicine Assessment Specific barriers Medical devices |
| url | http://link.springer.com/article/10.1186/s13063-017-2168-0 |
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