74 Trial-CARE: Centralized Support Services for Investigator-Initiated Multi-Site Clinical Trials
OBJECTIVES/GOALS: To describe the impact of Trial-CARE (Coordination, Acceleration, and Recruitment Enhancement), a centralized service core at Washington University (WU), aimed at enhancing the capability of investigator-initiated multi-site clinical trials at WU and partner CTSA institutions. METH...
| Main Authors: | , , |
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| Format: | Article |
| Language: | English |
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Cambridge University Press
2024-04-01
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| Series: | Journal of Clinical and Translational Science |
| Online Access: | https://www.cambridge.org/core/product/identifier/S2059866124000761/type/journal_article |
| _version_ | 1797226925036404736 |
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| author | Katie Keenoy Suresh Vedantham Emily Lake |
| author_facet | Katie Keenoy Suresh Vedantham Emily Lake |
| author_sort | Katie Keenoy |
| collection | DOAJ |
| description | OBJECTIVES/GOALS: To describe the impact of Trial-CARE (Coordination, Acceleration, and Recruitment Enhancement), a centralized service core at Washington University (WU), aimed at enhancing the capability of investigator-initiated multi-site clinical trials at WU and partner CTSA institutions. METHODS/STUDY POPULATION: Through review of our marketing materials and service tracking system we defined the following Trial-CARE offerings: Infrastructure: Trial-CARE is a centralized service core at WU. Whereby, a team member is sourced to an investigator-initiated multi-site clinical trial (II-MCT) to ensure the achievement of study milestones across any phase of the clinical trial life cycle. Team: Our team consists of research professionals with expertise in II-MCT project management, data management, and administrative/regulatory management. Services: * One free 60-minute case consultation * Tiers of Service * Academic Research Organization (ARO) support * Clinical Coordinating Center * Data Coordinating Center * II-MCT project management support * Time-limited targeted support RESULTS/ANTICIPATED RESULTS: Trial-CARE has completed 94 consultations in support of WU and partner CTSA institutions enabling the streamlining of study start-up; guidance for study recruitment, implementation, and operations; and offering resources to foster career development. Consultations can be completed at any phase in the clinical trial lifecycle, with Trial-CARE completing: * 12% in the idea phase * 45% in the grant development and submission stage * 28% after funding has been awarded Top reasons researchers connect with Trial-CARE about II-MCTs: * regulatory guidance (40%) * general information about Trial-CARE Services and II-MCTs (35%) * protocol development (21%) * data management (20%) * study budgeting (20%) DISCUSSION/SIGNIFICANCE: In response to a WU wide survey, Trial-CARE plans to generate informational webinars and is creating a clinical trial tracking dashboard, to pro-actively offer support services to researchers prior to grant funding. The goal is also to increase the percentage of consultations completed in the idea phase and the grant development and submission stage. |
| first_indexed | 2024-04-24T14:32:39Z |
| format | Article |
| id | doaj.art-f88be96ecc80468f9cc321ed96153b34 |
| institution | Directory Open Access Journal |
| issn | 2059-8661 |
| language | English |
| last_indexed | 2024-04-24T14:32:39Z |
| publishDate | 2024-04-01 |
| publisher | Cambridge University Press |
| record_format | Article |
| series | Journal of Clinical and Translational Science |
| spelling | doaj.art-f88be96ecc80468f9cc321ed96153b342024-04-03T02:00:11ZengCambridge University PressJournal of Clinical and Translational Science2059-86612024-04-018191910.1017/cts.2024.7674 Trial-CARE: Centralized Support Services for Investigator-Initiated Multi-Site Clinical TrialsKatie Keenoy0Suresh Vedantham1Emily Lake2Washington University in St. LouisWashington University in St. LouisWashington University in St. LouisOBJECTIVES/GOALS: To describe the impact of Trial-CARE (Coordination, Acceleration, and Recruitment Enhancement), a centralized service core at Washington University (WU), aimed at enhancing the capability of investigator-initiated multi-site clinical trials at WU and partner CTSA institutions. METHODS/STUDY POPULATION: Through review of our marketing materials and service tracking system we defined the following Trial-CARE offerings: Infrastructure: Trial-CARE is a centralized service core at WU. Whereby, a team member is sourced to an investigator-initiated multi-site clinical trial (II-MCT) to ensure the achievement of study milestones across any phase of the clinical trial life cycle. Team: Our team consists of research professionals with expertise in II-MCT project management, data management, and administrative/regulatory management. Services: * One free 60-minute case consultation * Tiers of Service * Academic Research Organization (ARO) support * Clinical Coordinating Center * Data Coordinating Center * II-MCT project management support * Time-limited targeted support RESULTS/ANTICIPATED RESULTS: Trial-CARE has completed 94 consultations in support of WU and partner CTSA institutions enabling the streamlining of study start-up; guidance for study recruitment, implementation, and operations; and offering resources to foster career development. Consultations can be completed at any phase in the clinical trial lifecycle, with Trial-CARE completing: * 12% in the idea phase * 45% in the grant development and submission stage * 28% after funding has been awarded Top reasons researchers connect with Trial-CARE about II-MCTs: * regulatory guidance (40%) * general information about Trial-CARE Services and II-MCTs (35%) * protocol development (21%) * data management (20%) * study budgeting (20%) DISCUSSION/SIGNIFICANCE: In response to a WU wide survey, Trial-CARE plans to generate informational webinars and is creating a clinical trial tracking dashboard, to pro-actively offer support services to researchers prior to grant funding. The goal is also to increase the percentage of consultations completed in the idea phase and the grant development and submission stage.https://www.cambridge.org/core/product/identifier/S2059866124000761/type/journal_article |
| spellingShingle | Katie Keenoy Suresh Vedantham Emily Lake 74 Trial-CARE: Centralized Support Services for Investigator-Initiated Multi-Site Clinical Trials Journal of Clinical and Translational Science |
| title | 74 Trial-CARE: Centralized Support Services for Investigator-Initiated Multi-Site Clinical Trials |
| title_full | 74 Trial-CARE: Centralized Support Services for Investigator-Initiated Multi-Site Clinical Trials |
| title_fullStr | 74 Trial-CARE: Centralized Support Services for Investigator-Initiated Multi-Site Clinical Trials |
| title_full_unstemmed | 74 Trial-CARE: Centralized Support Services for Investigator-Initiated Multi-Site Clinical Trials |
| title_short | 74 Trial-CARE: Centralized Support Services for Investigator-Initiated Multi-Site Clinical Trials |
| title_sort | 74 trial care centralized support services for investigator initiated multi site clinical trials |
| url | https://www.cambridge.org/core/product/identifier/S2059866124000761/type/journal_article |
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