Building an infrastructure to support the development, conduct, and reporting of informative clinical studies: The Rockefeller University experience
Abstract Introduction: Clinical trials are a vital component of translational science, providing crucial information on the efficacy and safety of new interventions and forming the basis for regulatory approval and/or clinical adoption. At the same time, they are complex to design, conduct, monito...
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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/S2059866123005216/type/journal_article |
| _version_ | 1797833475812753408 |
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| author | Rhonda G. Kost Rita K. Devine Mark Fernands Riva Gottesman Manoj Kandpal Robert B. MacArthur Barbara O’Sullivan Michelle Romanick Andrea Ronning Sarah Schlesinger Jonathan N. Tobin Roger Vaughan Maija Neville-Williams James G. Krueger Barry S. Coller |
| author_facet | Rhonda G. Kost Rita K. Devine Mark Fernands Riva Gottesman Manoj Kandpal Robert B. MacArthur Barbara O’Sullivan Michelle Romanick Andrea Ronning Sarah Schlesinger Jonathan N. Tobin Roger Vaughan Maija Neville-Williams James G. Krueger Barry S. Coller |
| author_sort | Rhonda G. Kost |
| collection | DOAJ |
| description |
Abstract
Introduction:
Clinical trials are a vital component of translational science, providing crucial information on the efficacy and safety of new interventions and forming the basis for regulatory approval and/or clinical adoption. At the same time, they are complex to design, conduct, monitor, and report successfully. Concerns over the last two decades about the quality of the design and the lack of completion and reporting of clinical trials, characterized as a lack of “informativeness,” highlighted by the experience during the COVID-19 pandemic, have led to several initiatives to address the serious shortcomings of the United States clinical research enterprise.
Methods and Results:
Against this background, we detail the policies, procedures, and programs that we have developed in The Rockefeller University Center for Clinical and Translational Science (CCTS), supported by a Clinical and Translational Science Award (CTSA) program grant since 2006, to support the development, conduct, and reporting of informative clinical studies.
Conclusions:
We have focused on building a data-driven infrastructure to both assist individual investigators and bring translational science to each element of the clinical investigation process, with the goal of both generating new knowledge and accelerating the uptake of that knowledge into practice.
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| first_indexed | 2024-04-09T14:23:40Z |
| format | Article |
| id | doaj.art-2c491e0718d2494eb07cd2435ab8b0d4 |
| institution | Directory Open Access Journal |
| issn | 2059-8661 |
| language | English |
| last_indexed | 2024-04-09T14:23:40Z |
| publishDate | 2023-01-01 |
| publisher | Cambridge University Press |
| record_format | Article |
| series | Journal of Clinical and Translational Science |
| spelling | doaj.art-2c491e0718d2494eb07cd2435ab8b0d42023-05-04T09:19:14ZengCambridge University PressJournal of Clinical and Translational Science2059-86612023-01-01710.1017/cts.2023.521Building an infrastructure to support the development, conduct, and reporting of informative clinical studies: The Rockefeller University experienceRhonda G. Kost0https://orcid.org/0000-0002-5419-0589Rita K. Devine1Mark Fernands2Riva Gottesman3Manoj Kandpal4Robert B. MacArthur5https://orcid.org/0000-0002-3264-4666Barbara O’Sullivan6Michelle Romanick7Andrea Ronning8Sarah Schlesinger9Jonathan N. Tobin10Roger Vaughan11https://orcid.org/0000-0002-1336-4079Maija Neville-Williams12James G. Krueger13Barry S. Coller14https://orcid.org/0000-0002-9078-7155Center for Clinical and Translational Science, Rockefeller University, New York, NY, USACenter for Clinical and Translational Science, Rockefeller University, New York, NY, USACenter for Clinical and Translational Science, Rockefeller University, New York, NY, USACenter for Clinical and Translational Science, Rockefeller University, New York, NY, USACenter for Clinical and Translational Science, Rockefeller University, New York, NY, USACenter for Clinical and Translational Science, Rockefeller University, New York, NY, USACenter for Clinical and Translational Science, Rockefeller University, New York, NY, USACenter for Clinical and Translational Science, Rockefeller University, New York, NY, USACenter for Clinical and Translational Science, Rockefeller University, New York, NY, USACenter for Clinical and Translational Science, Rockefeller University, New York, NY, USACenter for Clinical and Translational Science, Rockefeller University, New York, NY, USA Clinical Directors Network, Inc. (CDN), New York, NY, USACenter for Clinical and Translational Science, Rockefeller University, New York, NY, USACenter for Clinical and Translational Science, Rockefeller University, New York, NY, USACenter for Clinical and Translational Science, Rockefeller University, New York, NY, USACenter for Clinical and Translational Science, Rockefeller University, New York, NY, USA Abstract Introduction: Clinical trials are a vital component of translational science, providing crucial information on the efficacy and safety of new interventions and forming the basis for regulatory approval and/or clinical adoption. At the same time, they are complex to design, conduct, monitor, and report successfully. Concerns over the last two decades about the quality of the design and the lack of completion and reporting of clinical trials, characterized as a lack of “informativeness,” highlighted by the experience during the COVID-19 pandemic, have led to several initiatives to address the serious shortcomings of the United States clinical research enterprise. Methods and Results: Against this background, we detail the policies, procedures, and programs that we have developed in The Rockefeller University Center for Clinical and Translational Science (CCTS), supported by a Clinical and Translational Science Award (CTSA) program grant since 2006, to support the development, conduct, and reporting of informative clinical studies. Conclusions: We have focused on building a data-driven infrastructure to both assist individual investigators and bring translational science to each element of the clinical investigation process, with the goal of both generating new knowledge and accelerating the uptake of that knowledge into practice. https://www.cambridge.org/core/product/identifier/S2059866123005216/type/journal_articleClinical trialsCTSAmetricstranslational researchtranslational science |
| spellingShingle | Rhonda G. Kost Rita K. Devine Mark Fernands Riva Gottesman Manoj Kandpal Robert B. MacArthur Barbara O’Sullivan Michelle Romanick Andrea Ronning Sarah Schlesinger Jonathan N. Tobin Roger Vaughan Maija Neville-Williams James G. Krueger Barry S. Coller Building an infrastructure to support the development, conduct, and reporting of informative clinical studies: The Rockefeller University experience Journal of Clinical and Translational Science Clinical trials CTSA metrics translational research translational science |
| title | Building an infrastructure to support the development, conduct, and reporting of informative clinical studies: The Rockefeller University experience |
| title_full | Building an infrastructure to support the development, conduct, and reporting of informative clinical studies: The Rockefeller University experience |
| title_fullStr | Building an infrastructure to support the development, conduct, and reporting of informative clinical studies: The Rockefeller University experience |
| title_full_unstemmed | Building an infrastructure to support the development, conduct, and reporting of informative clinical studies: The Rockefeller University experience |
| title_short | Building an infrastructure to support the development, conduct, and reporting of informative clinical studies: The Rockefeller University experience |
| title_sort | building an infrastructure to support the development conduct and reporting of informative clinical studies the rockefeller university experience |
| topic | Clinical trials CTSA metrics translational research translational science |
| url | https://www.cambridge.org/core/product/identifier/S2059866123005216/type/journal_article |
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