A framework for assessing clinical trial site readiness
Clinical trial processes are unnecessarily inefficient and costly, slowing the translation of medical discoveries into treatments for people living with disease. To reduce redundancies and inefficiencies, a group of clinical trial experts developed a framework for clinical trial site readiness based...
| Main Authors: | , , , , , , , |
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| Format: | Article |
| Language: | English |
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Cambridge University Press
2023-01-01
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| Series: | Journal of Clinical and Translational Science |
| Subjects: | |
| Online Access: | https://www.cambridge.org/core/product/identifier/S2059866123005411/type/journal_article |
| _version_ | 1797783277741801472 |
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| author | John B. Buse Christopher P. Austin S. Claiborne Johnston Freda Lewis-Hall Andrew N. March Carolyn K. Shore Pamela Tenaerts Joni L. Rutter |
| author_facet | John B. Buse Christopher P. Austin S. Claiborne Johnston Freda Lewis-Hall Andrew N. March Carolyn K. Shore Pamela Tenaerts Joni L. Rutter |
| author_sort | John B. Buse |
| collection | DOAJ |
| description | Clinical trial processes are unnecessarily inefficient and costly, slowing the translation of medical discoveries into treatments for people living with disease. To reduce redundancies and inefficiencies, a group of clinical trial experts developed a framework for clinical trial site readiness based on existing trial site qualifications from sponsors. The site readiness practices are encompassed within six domains: research team, infrastructure, study management, data collection and management, quality oversight, and ethics and safety. Implementation of this framework for clinical trial sites would reduce inefficiencies in trial conduct and help prepare new sites to enter the clinical trials enterprise, with the potential to improve the reach of clinical trials to underserved communities. Moreover, the framework holds benefits for trial sponsors, contract research organizations, trade associations, trial participants, and the public. For novice sites considering future trials, we provide a framework for site preparation and the engagement of stakeholders. For experienced sites, the framework can be used to assess current practices and inform and engage sponsors, staff, and participants. Details in the supplementary materials provide easy access to key regulatory documents and resources. Invited perspective articles provide greater depth from a systems, DEIA (diversity, equity, inclusion, and accessibility) and decentralized trials perspective. |
| first_indexed | 2024-03-13T00:23:46Z |
| format | Article |
| id | doaj.art-fe08bffcee784decbaf2cd4fdc016cc4 |
| institution | Directory Open Access Journal |
| issn | 2059-8661 |
| language | English |
| last_indexed | 2024-03-13T00:23:46Z |
| publishDate | 2023-01-01 |
| publisher | Cambridge University Press |
| record_format | Article |
| series | Journal of Clinical and Translational Science |
| spelling | doaj.art-fe08bffcee784decbaf2cd4fdc016cc42023-07-11T10:21:20ZengCambridge University PressJournal of Clinical and Translational Science2059-86612023-01-01710.1017/cts.2023.541A framework for assessing clinical trial site readinessJohn B. Buse0https://orcid.org/0000-0002-9723-3876Christopher P. Austin1S. Claiborne Johnston2Freda Lewis-Hall3Andrew N. March4https://orcid.org/0000-0002-8575-7314Carolyn K. Shore5Pamela Tenaerts6Joni L. Rutter7Department of Medicine, University of North Carolina School of Medicine, Chapel Hill, North Carolina, USAFlagship Pioneering, Cambridge, Massachusetts, USAHarbor Health, Austin, TX, USARetired from Pfizer Inc., USANational Academies of Sciences, Engineering, and Medicine, Washington, District of Columbia, USANational Academies of Sciences, Engineering, and Medicine, Washington, District of Columbia, USAMedable, Inc, USANational Center for Advancing Translational Sciences, National Institutes of Health, Bethesda, Maryland, USAClinical trial processes are unnecessarily inefficient and costly, slowing the translation of medical discoveries into treatments for people living with disease. To reduce redundancies and inefficiencies, a group of clinical trial experts developed a framework for clinical trial site readiness based on existing trial site qualifications from sponsors. The site readiness practices are encompassed within six domains: research team, infrastructure, study management, data collection and management, quality oversight, and ethics and safety. Implementation of this framework for clinical trial sites would reduce inefficiencies in trial conduct and help prepare new sites to enter the clinical trials enterprise, with the potential to improve the reach of clinical trials to underserved communities. Moreover, the framework holds benefits for trial sponsors, contract research organizations, trade associations, trial participants, and the public. For novice sites considering future trials, we provide a framework for site preparation and the engagement of stakeholders. For experienced sites, the framework can be used to assess current practices and inform and engage sponsors, staff, and participants. Details in the supplementary materials provide easy access to key regulatory documents and resources. Invited perspective articles provide greater depth from a systems, DEIA (diversity, equity, inclusion, and accessibility) and decentralized trials perspective.https://www.cambridge.org/core/product/identifier/S2059866123005411/type/journal_articleClinical trial sitessite readiness practicesquality improvementevaluationadoption and implementation |
| spellingShingle | John B. Buse Christopher P. Austin S. Claiborne Johnston Freda Lewis-Hall Andrew N. March Carolyn K. Shore Pamela Tenaerts Joni L. Rutter A framework for assessing clinical trial site readiness Journal of Clinical and Translational Science Clinical trial sites site readiness practices quality improvement evaluation adoption and implementation |
| title | A framework for assessing clinical trial site readiness |
| title_full | A framework for assessing clinical trial site readiness |
| title_fullStr | A framework for assessing clinical trial site readiness |
| title_full_unstemmed | A framework for assessing clinical trial site readiness |
| title_short | A framework for assessing clinical trial site readiness |
| title_sort | framework for assessing clinical trial site readiness |
| topic | Clinical trial sites site readiness practices quality improvement evaluation adoption and implementation |
| url | https://www.cambridge.org/core/product/identifier/S2059866123005411/type/journal_article |
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