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DC Field | Value | Language |
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dc.contributor.author | Helanterä, Ilkka | - |
dc.contributor.author | Snyder, Jon | - |
dc.contributor.author | Åsberg, Anders | - |
dc.contributor.author | Cruzado, Josep Ma. | - |
dc.contributor.author | Bell, Samira | - |
dc.contributor.author | Legendre, Christophe | - |
dc.contributor.author | Tedesco Silva, Hélio | - |
dc.contributor.author | Tedesco Barcelos, Giovanna | - |
dc.contributor.author | Geissbühler, Yvonne | - |
dc.contributor.author | Prieto, Luis | - |
dc.contributor.author | Christian, Jennifer B. | - |
dc.contributor.author | Scalfaro, Erik | - |
dc.contributor.author | Dreyer, Nancy A. | - |
dc.date.accessioned | 2022-07-22T15:46:01Z | - |
dc.date.available | 2022-07-22T15:46:01Z | - |
dc.date.issued | 2022-05-03 | - |
dc.identifier.uri | http://hdl.handle.net/2445/187954 | - |
dc.description.abstract | While great progress has been made in transplantation medicine, long-term graft failure and serious side effects still pose a challenge in kidney transplantation. Effective and safe long-term treatments are needed. Therefore, evidence of the lasting benefit-risk of novel therapies is required. Demonstrating superiority of novel therapies is unlikely via conventional randomized controlled trials, as long-term follow-up in large sample sizes pose statistical and operational challenges. Furthermore, endpoints generally accepted in short-term clinical trials need to be translated to real-world (RW) care settings, enabling robust assessments of novel treatments. Hence, there is an evidence gap that calls for innovative clinical trial designs, with RW evidence (RWE) providing an opportunity to facilitate longitudinal transplant research with timely translation to clinical practice. Nonetheless, the current RWE landscape shows considerable heterogeneity, with few registries capturing detailed data to support the establishment of new endpoints. The main recommendations by leading scientists in the field are increased collaboration between registries for data harmonization and leveraging the development of technology innovations for data sharing under high privacy standards. This will aid the development of clinically meaningful endpoints and data models, enabling future long-term research and ultimately establish optimal long-term outcomes for transplant patients. | - |
dc.format.extent | 8 p. | - |
dc.format.mimetype | application/pdf | - |
dc.language.iso | eng | - |
dc.publisher | Frontiers Media SA | - |
dc.relation.isformatof | Reproducció del document publicat a: https://doi.org/10.3389/ti.2022.10329 | - |
dc.relation.ispartof | Transplant International, 2022, vol. 35, num. 10329 | - |
dc.relation.uri | https://doi.org/10.3389/ti.2022.10329 | - |
dc.rights | cc by (c) Helanterä, Ilkka et al., 2022 | - |
dc.rights.uri | http://creativecommons.org/licenses/by/3.0/es/ | * |
dc.source | Articles publicats en revistes (Ciències Clíniques) | - |
dc.subject.classification | Trasplantament renal | - |
dc.subject.classification | Assaigs clínics | - |
dc.subject.other | Kidney transplantation | - |
dc.subject.other | Clinical trials | - |
dc.title | Demonstrating Benefit-Risk Profiles of Novel Therapeutic Strategies in Kidney Transplantation: Opportunities and Challenges of Real-World Evidence | - |
dc.type | info:eu-repo/semantics/article | - |
dc.type | info:eu-repo/semantics/publishedVersion | - |
dc.date.updated | 2022-07-21T10:08:31Z | - |
dc.rights.accessRights | info:eu-repo/semantics/openAccess | - |
dc.identifier.pmid | 35592446 | - |
Appears in Collections: | Articles publicats en revistes (Ciències Clíniques) Articles publicats en revistes (Institut d'lnvestigació Biomèdica de Bellvitge (IDIBELL)) |
Files in This Item:
File | Description | Size | Format | |
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ti-35-10329.pdf | 1.2 MB | Adobe PDF | View/Open |
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