Framework of the strengths and challenges of clinically integrated trials: an expert panel report
The limitations of the explanatory clinical trial framework include the high expense of implementing explanatory trials, restrictive entry criteria for participants, and redundant logistical processes. These limitations can result in slow evidence generation that is not responsive to population heal...
| Päätekijät: | , , , , , , , , , , , , , , , , , , , , , |
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| Aineistotyyppi: | Journal article |
| Kieli: | English |
| Julkaistu: |
Elsevier
2024
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| _version_ | 1826315359019335680 |
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| author | Peters, AE Jones, WS Anderson, B Bramante, CT Broedl, U Hornik, CP Kehoe, L Knowlton, KU Krofah, E Landray, M Locke, T Patel, MR Psotka, M Rockhold, FW Roessig, L Rothman, RL Schofield, L Stockbridge, N Trontell, A Curtis, LH Tenaerts, P Hernandez, AF |
| author_facet | Peters, AE Jones, WS Anderson, B Bramante, CT Broedl, U Hornik, CP Kehoe, L Knowlton, KU Krofah, E Landray, M Locke, T Patel, MR Psotka, M Rockhold, FW Roessig, L Rothman, RL Schofield, L Stockbridge, N Trontell, A Curtis, LH Tenaerts, P Hernandez, AF |
| author_sort | Peters, AE |
| collection | OXFORD |
| description | The limitations of the explanatory clinical trial framework include the high expense of implementing explanatory trials, restrictive entry criteria for participants, and redundant logistical processes. These limitations can result in slow evidence generation that is not responsive to population health needs, yielding evidence that is not generalizable. Clinically integrated trials, which integrate clinical research into routine care, represent a potential solution to this challenge and an opportunity to support learning health systems. The operational and design features of clinically integrated trials include a focused scope, simplicity in design and requirements, the leveraging of existing data structures, and patient participation in the entire trial process. These features are designed to minimize barriers to participation and trial execution and reduce additional research burdens for participants and clinicians alike. Broad adoption and scalability of clinically integrated trials are dependent, in part, on continuing regulatory, healthcare system, and payer support. This analysis presents a framework of the strengths and challenges of clinically integrated trials and is based on a multidisciplinary expert “Think Tank” panel discussion that included representatives from patient populations, academia, non-profit funding agencies, the U.S. Food and Drug Administration, and industry. |
| first_indexed | 2024-09-25T04:05:31Z |
| format | Journal article |
| id | oxford-uuid:9b4ba81a-251c-43b4-a640-8c7310e7d3fb |
| institution | University of Oxford |
| language | English |
| last_indexed | 2024-12-09T03:24:08Z |
| publishDate | 2024 |
| publisher | Elsevier |
| record_format | dspace |
| spelling | oxford-uuid:9b4ba81a-251c-43b4-a640-8c7310e7d3fb2024-11-22T12:28:35ZFramework of the strengths and challenges of clinically integrated trials: an expert panel reportJournal articlehttp://purl.org/coar/resource_type/c_dcae04bcuuid:9b4ba81a-251c-43b4-a640-8c7310e7d3fbEnglishSymplectic ElementsElsevier2024Peters, AEJones, WSAnderson, BBramante, CTBroedl, UHornik, CPKehoe, LKnowlton, KUKrofah, ELandray, MLocke, TPatel, MRPsotka, MRockhold, FWRoessig, LRothman, RLSchofield, LStockbridge, NTrontell, ACurtis, LHTenaerts, PHernandez, AFThe limitations of the explanatory clinical trial framework include the high expense of implementing explanatory trials, restrictive entry criteria for participants, and redundant logistical processes. These limitations can result in slow evidence generation that is not responsive to population health needs, yielding evidence that is not generalizable. Clinically integrated trials, which integrate clinical research into routine care, represent a potential solution to this challenge and an opportunity to support learning health systems. The operational and design features of clinically integrated trials include a focused scope, simplicity in design and requirements, the leveraging of existing data structures, and patient participation in the entire trial process. These features are designed to minimize barriers to participation and trial execution and reduce additional research burdens for participants and clinicians alike. Broad adoption and scalability of clinically integrated trials are dependent, in part, on continuing regulatory, healthcare system, and payer support. This analysis presents a framework of the strengths and challenges of clinically integrated trials and is based on a multidisciplinary expert “Think Tank” panel discussion that included representatives from patient populations, academia, non-profit funding agencies, the U.S. Food and Drug Administration, and industry. |
| spellingShingle | Peters, AE Jones, WS Anderson, B Bramante, CT Broedl, U Hornik, CP Kehoe, L Knowlton, KU Krofah, E Landray, M Locke, T Patel, MR Psotka, M Rockhold, FW Roessig, L Rothman, RL Schofield, L Stockbridge, N Trontell, A Curtis, LH Tenaerts, P Hernandez, AF Framework of the strengths and challenges of clinically integrated trials: an expert panel report |
| title | Framework of the strengths and challenges of clinically integrated trials: an expert panel report |
| title_full | Framework of the strengths and challenges of clinically integrated trials: an expert panel report |
| title_fullStr | Framework of the strengths and challenges of clinically integrated trials: an expert panel report |
| title_full_unstemmed | Framework of the strengths and challenges of clinically integrated trials: an expert panel report |
| title_short | Framework of the strengths and challenges of clinically integrated trials: an expert panel report |
| title_sort | framework of the strengths and challenges of clinically integrated trials an expert panel report |
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