How to implement the ‘one patient, one vote’ principle under the framework of estimand
The scientific foundation of a modern clinical trial is randomization – each patient is randomized to a treatment group, and statistical comparisons are made between treatment groups. Because the study units are individual patients, this ‘one patient, one vote’ principle needs to be followed – both...
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| Format: | Article |
| Language: | English |
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Taylor & Francis Group
2023-07-01
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| Series: | Statistical Theory and Related Fields |
| Subjects: | |
| Online Access: | http://dx.doi.org/10.1080/24754269.2023.2164943 |
| _version_ | 1797677048623267840 |
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| author | Naitee Ting |
| author_facet | Naitee Ting |
| author_sort | Naitee Ting |
| collection | DOAJ |
| description | The scientific foundation of a modern clinical trial is randomization – each patient is randomized to a treatment group, and statistical comparisons are made between treatment groups. Because the study units are individual patients, this ‘one patient, one vote’ principle needs to be followed – both in study design and in data analysis. From the physicians' point of view, each patient is equally important, and they need to be treated equally in data analysis. It is critical that statistical analysis should respect design and study design is based on randomization. Hence from both statistical and medical points of view, data analysis needs to follow this ‘one patient, one vote’ principle. Under ICH E9 (R1), five strategies are recommended to establish ‘estimand’. This paper discusses how to implement these strategies using the ‘one patient, one vote’ principle. |
| first_indexed | 2024-03-11T22:39:20Z |
| format | Article |
| id | doaj.art-ee8b124eb1504b5fb63e43555152e4de |
| institution | Directory Open Access Journal |
| issn | 2475-4269 2475-4277 |
| language | English |
| last_indexed | 2024-03-11T22:39:20Z |
| publishDate | 2023-07-01 |
| publisher | Taylor & Francis Group |
| record_format | Article |
| series | Statistical Theory and Related Fields |
| spelling | doaj.art-ee8b124eb1504b5fb63e43555152e4de2023-09-22T09:19:46ZengTaylor & Francis GroupStatistical Theory and Related Fields2475-42692475-42772023-07-017320221210.1080/24754269.2023.21649432164943How to implement the ‘one patient, one vote’ principle under the framework of estimandNaitee Ting0Boehringer Ingelheim Pharmaceuticals, IncThe scientific foundation of a modern clinical trial is randomization – each patient is randomized to a treatment group, and statistical comparisons are made between treatment groups. Because the study units are individual patients, this ‘one patient, one vote’ principle needs to be followed – both in study design and in data analysis. From the physicians' point of view, each patient is equally important, and they need to be treated equally in data analysis. It is critical that statistical analysis should respect design and study design is based on randomization. Hence from both statistical and medical points of view, data analysis needs to follow this ‘one patient, one vote’ principle. Under ICH E9 (R1), five strategies are recommended to establish ‘estimand’. This paper discusses how to implement these strategies using the ‘one patient, one vote’ principle.http://dx.doi.org/10.1080/24754269.2023.2164943estimandlocfone patient one vote |
| spellingShingle | Naitee Ting How to implement the ‘one patient, one vote’ principle under the framework of estimand Statistical Theory and Related Fields estimand locf one patient one vote |
| title | How to implement the ‘one patient, one vote’ principle under the framework of estimand |
| title_full | How to implement the ‘one patient, one vote’ principle under the framework of estimand |
| title_fullStr | How to implement the ‘one patient, one vote’ principle under the framework of estimand |
| title_full_unstemmed | How to implement the ‘one patient, one vote’ principle under the framework of estimand |
| title_short | How to implement the ‘one patient, one vote’ principle under the framework of estimand |
| title_sort | how to implement the one patient one vote principle under the framework of estimand |
| topic | estimand locf one patient one vote |
| url | http://dx.doi.org/10.1080/24754269.2023.2164943 |
| work_keys_str_mv | AT naiteeting howtoimplementtheonepatientonevoteprincipleundertheframeworkofestimand |