External Comparator Cohort studies - clarification of terminology
Though there is only one term for the gold standard of Randomized Controlled Trials the terminology used for controlled research involving external data is diverse. Common terms include External Comparator/Control Arm study, Externally Controlled Trial, Synthetic Control study and Historical Control...
| Main Authors: | , , , , , |
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| Format: | Article |
| Language: | English |
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Frontiers Media S.A.
2024-01-01
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| Series: | Frontiers in Drug Safety and Regulation |
| Subjects: | |
| Online Access: | https://www.frontiersin.org/articles/10.3389/fdsfr.2023.1321894/full |
| _version_ | 1797333400988680192 |
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| author | Gerd Rippin Joan Largent Wilhelmina Elisabeth Hoogendoorn Héctor Sanz Jaclyn Bosco Christina Mack |
| author_facet | Gerd Rippin Joan Largent Wilhelmina Elisabeth Hoogendoorn Héctor Sanz Jaclyn Bosco Christina Mack |
| author_sort | Gerd Rippin |
| collection | DOAJ |
| description | Though there is only one term for the gold standard of Randomized Controlled Trials the terminology used for controlled research involving external data is diverse. Common terms include External Comparator/Control Arm study, Externally Controlled Trial, Synthetic Control study and Historical Control study. The term Externally Controlled Trial was recently selected by the U.S. Food and Drug Administration (FDA) and is in line with the use case of a pivotal trial. It entails pre-specification of the external dataset and its analysis in the trial protocol, which produces the highest amount of transparency, which is an important aspect for maximum credibility. If this pre-specification did not occur, we advocate the term External Comparator Cohort study (or short External Comparator study), which is derived by scrutinizing the paired terms study/trial, control/comparator and arm/cohort. Furthermore, we propose an overall framework of nomenclature, which is generally applicable for research projects involving external data. Only a precise and consistent use of terminology will most effectively safeguard from unintended implications, inaccurate perceptions, and misguided mindsets. |
| first_indexed | 2024-03-08T08:03:19Z |
| format | Article |
| id | doaj.art-216f765427e34c1eb7ef3ac3d3a998cb |
| institution | Directory Open Access Journal |
| issn | 2674-0869 |
| language | English |
| last_indexed | 2024-03-08T08:03:19Z |
| publishDate | 2024-01-01 |
| publisher | Frontiers Media S.A. |
| record_format | Article |
| series | Frontiers in Drug Safety and Regulation |
| spelling | doaj.art-216f765427e34c1eb7ef3ac3d3a998cb2024-02-02T11:39:12ZengFrontiers Media S.A.Frontiers in Drug Safety and Regulation2674-08692024-01-01310.3389/fdsfr.2023.13218941321894External Comparator Cohort studies - clarification of terminologyGerd Rippin0Joan Largent1Wilhelmina Elisabeth Hoogendoorn2Héctor Sanz3Jaclyn Bosco4Christina Mack5IQVIA, Biostatistics, Frankfurt, GermanyIQVIA, Epidemiology, Boston, CA, United StatesIQVIA, Epidemiology, Amsterdam, NetherlandsIQVIA, Biostatistics, Barcelona, SpainIQVIA, Epidemiology, Boston, MA, United StatesIQVIA, Epidemiology, Research Triangle Park, NC, United StatesThough there is only one term for the gold standard of Randomized Controlled Trials the terminology used for controlled research involving external data is diverse. Common terms include External Comparator/Control Arm study, Externally Controlled Trial, Synthetic Control study and Historical Control study. The term Externally Controlled Trial was recently selected by the U.S. Food and Drug Administration (FDA) and is in line with the use case of a pivotal trial. It entails pre-specification of the external dataset and its analysis in the trial protocol, which produces the highest amount of transparency, which is an important aspect for maximum credibility. If this pre-specification did not occur, we advocate the term External Comparator Cohort study (or short External Comparator study), which is derived by scrutinizing the paired terms study/trial, control/comparator and arm/cohort. Furthermore, we propose an overall framework of nomenclature, which is generally applicable for research projects involving external data. Only a precise and consistent use of terminology will most effectively safeguard from unintended implications, inaccurate perceptions, and misguided mindsets.https://www.frontiersin.org/articles/10.3389/fdsfr.2023.1321894/fullExternal Comparator studiesExternal Comparator Cohort studiesExternal Comparator Arm studiesExternally Controlled TrialsHistorical Control studiesSynthetic Control studies |
| spellingShingle | Gerd Rippin Joan Largent Wilhelmina Elisabeth Hoogendoorn Héctor Sanz Jaclyn Bosco Christina Mack External Comparator Cohort studies - clarification of terminology Frontiers in Drug Safety and Regulation External Comparator studies External Comparator Cohort studies External Comparator Arm studies Externally Controlled Trials Historical Control studies Synthetic Control studies |
| title | External Comparator Cohort studies - clarification of terminology |
| title_full | External Comparator Cohort studies - clarification of terminology |
| title_fullStr | External Comparator Cohort studies - clarification of terminology |
| title_full_unstemmed | External Comparator Cohort studies - clarification of terminology |
| title_short | External Comparator Cohort studies - clarification of terminology |
| title_sort | external comparator cohort studies clarification of terminology |
| topic | External Comparator studies External Comparator Cohort studies External Comparator Arm studies Externally Controlled Trials Historical Control studies Synthetic Control studies |
| url | https://www.frontiersin.org/articles/10.3389/fdsfr.2023.1321894/full |
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