Randomized Registry Trials - efficient post market clinical follow-up for medical devices
In spite of advances in the treatment of cardiovascular disease, there remains a significant need for high-quality evidence for clinical practice given the rising prevalence worldwide. Next to the increase of regulatory requirements, poor screening-to-recruitment ratios, lack of patient engagement,...
| Main Authors: | , , , , , |
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| Format: | Article |
| Language: | English |
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De Gruyter
2023-09-01
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| Series: | Current Directions in Biomedical Engineering |
| Subjects: | |
| Online Access: | https://doi.org/10.1515/cdbme-2023-1122 |
| _version_ | 1797646336304087040 |
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| author | Leuchter Matthias Siewert Stefan Stiehm Michael Klar Ernst Schmitz Klaus-Peter Kaule Sebastian |
| author_facet | Leuchter Matthias Siewert Stefan Stiehm Michael Klar Ernst Schmitz Klaus-Peter Kaule Sebastian |
| author_sort | Leuchter Matthias |
| collection | DOAJ |
| description | In spite of advances in the treatment of cardiovascular disease, there remains a significant need for high-quality evidence for clinical practice given the rising prevalence worldwide. Next to the increase of regulatory requirements, poor screening-to-recruitment ratios, lack of patient engagement, and long timelines for contracting and institutional review board (IRB) approval are leading to an outflow of clinical trials in the EU. Patient registries are a potentially rich source of data, especially for evaluating the course of rare diseases and effects of new treatments. In the sectors of regulatory assessments of medical devices they are greatly underused. Health-related real world data provide crucial support for regulatory decision-making, particularly post-market assessments of medical products. Registries can be used not only for observational studies, but also for conducting experimental study designs. Register-based randomized controlled trials (RRCTs) are of particular importance here, as they can combine the advantages of randomized controlled trials (RCT) and registers. The government's financial support and reduction of regulatory barriers to the implementation of registry-based RCT are incentive factors for manufacturers to let their medical devices (re-)certified. Furthermore, it is essential that the necessary criteria are already taken into account when setting up the German implant registry in order to enable future RRCTs. The presented work is an additional pleading for the use and extension of registries for all medical products. |
| first_indexed | 2024-03-11T15:01:11Z |
| format | Article |
| id | doaj.art-c551dce07b064e928b6ab4100ec6418e |
| institution | Directory Open Access Journal |
| issn | 2364-5504 |
| language | English |
| last_indexed | 2024-03-11T15:01:11Z |
| publishDate | 2023-09-01 |
| publisher | De Gruyter |
| record_format | Article |
| series | Current Directions in Biomedical Engineering |
| spelling | doaj.art-c551dce07b064e928b6ab4100ec6418e2023-10-30T07:58:12ZengDe GruyterCurrent Directions in Biomedical Engineering2364-55042023-09-019148749010.1515/cdbme-2023-1122Randomized Registry Trials - efficient post market clinical follow-up for medical devicesLeuchter Matthias0Siewert Stefan1Stiehm Michael2Klar Ernst3Schmitz Klaus-Peter4Kaule Sebastian5Institute for ImplantTechnology and Biomaterials e.V., Rostock-Warnemünde, GermanyInstitute for ImplantTechnology and Biomaterials e.V., Rostock-Warnemünde, GermanyInstitute for ImplantTechnology and Biomaterials e.V., Rostock-Warnemünde, GermanyDepartment of Surgery, University Medical Center Rostock, Rostock, GermanyInstitute for ImplantTechnology and Biomaterials e.V., Rostock-Warnemünde, GermanyInstitute for ImplantTechnology and Biomaterials e.V., Rostock-Warnemünde, GermanyIn spite of advances in the treatment of cardiovascular disease, there remains a significant need for high-quality evidence for clinical practice given the rising prevalence worldwide. Next to the increase of regulatory requirements, poor screening-to-recruitment ratios, lack of patient engagement, and long timelines for contracting and institutional review board (IRB) approval are leading to an outflow of clinical trials in the EU. Patient registries are a potentially rich source of data, especially for evaluating the course of rare diseases and effects of new treatments. In the sectors of regulatory assessments of medical devices they are greatly underused. Health-related real world data provide crucial support for regulatory decision-making, particularly post-market assessments of medical products. Registries can be used not only for observational studies, but also for conducting experimental study designs. Register-based randomized controlled trials (RRCTs) are of particular importance here, as they can combine the advantages of randomized controlled trials (RCT) and registers. The government's financial support and reduction of regulatory barriers to the implementation of registry-based RCT are incentive factors for manufacturers to let their medical devices (re-)certified. Furthermore, it is essential that the necessary criteria are already taken into account when setting up the German implant registry in order to enable future RRCTs. The presented work is an additional pleading for the use and extension of registries for all medical products.https://doi.org/10.1515/cdbme-2023-1122medical device regulationpost-market clinical follow-upregistriesregulatory affairs |
| spellingShingle | Leuchter Matthias Siewert Stefan Stiehm Michael Klar Ernst Schmitz Klaus-Peter Kaule Sebastian Randomized Registry Trials - efficient post market clinical follow-up for medical devices Current Directions in Biomedical Engineering medical device regulation post-market clinical follow-up registries regulatory affairs |
| title | Randomized Registry Trials - efficient post market clinical follow-up for medical devices |
| title_full | Randomized Registry Trials - efficient post market clinical follow-up for medical devices |
| title_fullStr | Randomized Registry Trials - efficient post market clinical follow-up for medical devices |
| title_full_unstemmed | Randomized Registry Trials - efficient post market clinical follow-up for medical devices |
| title_short | Randomized Registry Trials - efficient post market clinical follow-up for medical devices |
| title_sort | randomized registry trials efficient post market clinical follow up for medical devices |
| topic | medical device regulation post-market clinical follow-up registries regulatory affairs |
| url | https://doi.org/10.1515/cdbme-2023-1122 |
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