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Quantifying and visualizing site performance in clinical trials

BACKGROUND: One of the keys to running a successful clinical trial is the selection of high quality clinical sites, i.e., sites that are able to enroll patients quickly, engage them on an ongoing basis to prevent drop-out, and execute the trial in strict accordance to the clinical protocol. Intuitiv...

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Autores principales: Yang, Eric, O'Donovan, Christopher, Phillips, JodiLyn, Atkinson, Leone, Ghosh, Krishnendu, Agrafiotis, Dimitris K.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Elsevier 2018
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5898563/
https://www.ncbi.nlm.nih.gov/pubmed/29696232
http://dx.doi.org/10.1016/j.conctc.2018.01.005
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author Yang, Eric
O'Donovan, Christopher
Phillips, JodiLyn
Atkinson, Leone
Ghosh, Krishnendu
Agrafiotis, Dimitris K.
author_facet Yang, Eric
O'Donovan, Christopher
Phillips, JodiLyn
Atkinson, Leone
Ghosh, Krishnendu
Agrafiotis, Dimitris K.
author_sort Yang, Eric
collection PubMed
description BACKGROUND: One of the keys to running a successful clinical trial is the selection of high quality clinical sites, i.e., sites that are able to enroll patients quickly, engage them on an ongoing basis to prevent drop-out, and execute the trial in strict accordance to the clinical protocol. Intuitively, the historical track record of a site is one of the strongest predictors of its future performance; however, issues such as data availability and wide differences in protocol complexity can complicate interpretation. Here, we demonstrate how operational data derived from central laboratory services can provide key insights into the performance of clinical sites and help guide operational planning and site selection for new clinical trials. METHODS: Our methodology uses the metadata associated with laboratory kit shipments to clinical sites (such as trial and anonymized patient identifiers, investigator names and addresses, sample collection and shipment dates, etc.) to reconstruct the complete schedule of patient visits and derive insights about the operational performance of those sites, including screening, enrollment, and drop-out rates and other quality indicators. This information can be displayed in its raw form or normalized to enable direct comparison of site performance across studies of varied design and complexity. RESULTS: Leveraging Covance's market leadership in central laboratory services, we have assembled a database of operational metrics that spans more than 14,000 protocols, 1400 indications, 230,000 unique investigators, and 23 million patient visits and represents a significant fraction of all clinical trials run globally in the last few years. By analyzing this historical data, we are able to assess and compare the performance of clinical investigators across a wide range of therapeutic areas and study designs. This information can be aggregated across trials and geographies to gain further insights into country and regional trends, sometimes with surprising results. CONCLUSIONS: The use of operational data from Covance Central Laboratories provides a unique perspective into the performance of clinical sites with respect to many important metrics such as patient enrollment and retention. These metrics can, in turn, be used to guide operational planning and site selection for new clinical trials, thereby accelerating recruitment, improving quality, and reducing cost.
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spelling pubmed-58985632018-04-25 Quantifying and visualizing site performance in clinical trials Yang, Eric O'Donovan, Christopher Phillips, JodiLyn Atkinson, Leone Ghosh, Krishnendu Agrafiotis, Dimitris K. Contemp Clin Trials Commun Article BACKGROUND: One of the keys to running a successful clinical trial is the selection of high quality clinical sites, i.e., sites that are able to enroll patients quickly, engage them on an ongoing basis to prevent drop-out, and execute the trial in strict accordance to the clinical protocol. Intuitively, the historical track record of a site is one of the strongest predictors of its future performance; however, issues such as data availability and wide differences in protocol complexity can complicate interpretation. Here, we demonstrate how operational data derived from central laboratory services can provide key insights into the performance of clinical sites and help guide operational planning and site selection for new clinical trials. METHODS: Our methodology uses the metadata associated with laboratory kit shipments to clinical sites (such as trial and anonymized patient identifiers, investigator names and addresses, sample collection and shipment dates, etc.) to reconstruct the complete schedule of patient visits and derive insights about the operational performance of those sites, including screening, enrollment, and drop-out rates and other quality indicators. This information can be displayed in its raw form or normalized to enable direct comparison of site performance across studies of varied design and complexity. RESULTS: Leveraging Covance's market leadership in central laboratory services, we have assembled a database of operational metrics that spans more than 14,000 protocols, 1400 indications, 230,000 unique investigators, and 23 million patient visits and represents a significant fraction of all clinical trials run globally in the last few years. By analyzing this historical data, we are able to assess and compare the performance of clinical investigators across a wide range of therapeutic areas and study designs. This information can be aggregated across trials and geographies to gain further insights into country and regional trends, sometimes with surprising results. CONCLUSIONS: The use of operational data from Covance Central Laboratories provides a unique perspective into the performance of clinical sites with respect to many important metrics such as patient enrollment and retention. These metrics can, in turn, be used to guide operational planning and site selection for new clinical trials, thereby accelerating recruitment, improving quality, and reducing cost. Elsevier 2018-01-31 /pmc/articles/PMC5898563/ /pubmed/29696232 http://dx.doi.org/10.1016/j.conctc.2018.01.005 Text en © 2018 Covance, Inc. http://creativecommons.org/licenses/by/4.0/ This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/).
spellingShingle Article
Yang, Eric
O'Donovan, Christopher
Phillips, JodiLyn
Atkinson, Leone
Ghosh, Krishnendu
Agrafiotis, Dimitris K.
Quantifying and visualizing site performance in clinical trials
title Quantifying and visualizing site performance in clinical trials
title_full Quantifying and visualizing site performance in clinical trials
title_fullStr Quantifying and visualizing site performance in clinical trials
title_full_unstemmed Quantifying and visualizing site performance in clinical trials
title_short Quantifying and visualizing site performance in clinical trials
title_sort quantifying and visualizing site performance in clinical trials
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5898563/
https://www.ncbi.nlm.nih.gov/pubmed/29696232
http://dx.doi.org/10.1016/j.conctc.2018.01.005
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