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Early phase clinical trials extension to guidelines for the content of statistical analysis plans
This paper reports guidelines for the content of statistical analysis plans for early phase clinical trials, ensuring specification of the minimum reporting analysis requirements, by detailing extensions (11 new items) and modifications (25 items) to existing guidance after a review by various stake...
| Autores principales: | , , , , , , , , , , , , , , , , , , |
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| Formato: | Online Artículo Texto |
| Lenguaje: | English |
| Publicado: |
BMJ Publishing Group Ltd.
2022
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| Materias: | |
| Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8819597/ https://www.ncbi.nlm.nih.gov/pubmed/35131744 http://dx.doi.org/10.1136/bmj-2021-068177 |
| _version_ | 1784646089998073856 |
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| author | Homer, Victoria Yap, Christina Bond, Simon Holmes, Jane Stocken, Deborah Walker, Katrina Robinson, Emily J Wheeler, Graham Brown, Sarah Hinsley, Samantha Schipper, Matthew Weir, Christopher J Rantell, Khadija Prior, Thomas Yu, Ly-Mee Kirkpatrick, John Bedding, Alun Gamble, Carrol Gaunt, Piers |
| author_facet | Homer, Victoria Yap, Christina Bond, Simon Holmes, Jane Stocken, Deborah Walker, Katrina Robinson, Emily J Wheeler, Graham Brown, Sarah Hinsley, Samantha Schipper, Matthew Weir, Christopher J Rantell, Khadija Prior, Thomas Yu, Ly-Mee Kirkpatrick, John Bedding, Alun Gamble, Carrol Gaunt, Piers |
| author_sort | Homer, Victoria |
| collection | PubMed |
| description | This paper reports guidelines for the content of statistical analysis plans for early phase clinical trials, ensuring specification of the minimum reporting analysis requirements, by detailing extensions (11 new items) and modifications (25 items) to existing guidance after a review by various stakeholders. |
| format | Online Article Text |
| id | pubmed-8819597 |
| institution | National Center for Biotechnology Information |
| language | English |
| publishDate | 2022 |
| publisher | BMJ Publishing Group Ltd. |
| record_format | MEDLINE/PubMed |
| spelling | pubmed-88195972022-02-08 Early phase clinical trials extension to guidelines for the content of statistical analysis plans Homer, Victoria Yap, Christina Bond, Simon Holmes, Jane Stocken, Deborah Walker, Katrina Robinson, Emily J Wheeler, Graham Brown, Sarah Hinsley, Samantha Schipper, Matthew Weir, Christopher J Rantell, Khadija Prior, Thomas Yu, Ly-Mee Kirkpatrick, John Bedding, Alun Gamble, Carrol Gaunt, Piers BMJ Research Methods & Reporting This paper reports guidelines for the content of statistical analysis plans for early phase clinical trials, ensuring specification of the minimum reporting analysis requirements, by detailing extensions (11 new items) and modifications (25 items) to existing guidance after a review by various stakeholders. BMJ Publishing Group Ltd. 2022-02-07 /pmc/articles/PMC8819597/ /pubmed/35131744 http://dx.doi.org/10.1136/bmj-2021-068177 Text en © Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. https://creativecommons.org/licenses/by-nc/4.0/This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/ (https://creativecommons.org/licenses/by-nc/4.0/) . |
| spellingShingle | Research Methods & Reporting Homer, Victoria Yap, Christina Bond, Simon Holmes, Jane Stocken, Deborah Walker, Katrina Robinson, Emily J Wheeler, Graham Brown, Sarah Hinsley, Samantha Schipper, Matthew Weir, Christopher J Rantell, Khadija Prior, Thomas Yu, Ly-Mee Kirkpatrick, John Bedding, Alun Gamble, Carrol Gaunt, Piers Early phase clinical trials extension to guidelines for the content of statistical analysis plans |
| title | Early phase clinical trials extension to guidelines for the content of statistical analysis plans |
| title_full | Early phase clinical trials extension to guidelines for the content of statistical analysis plans |
| title_fullStr | Early phase clinical trials extension to guidelines for the content of statistical analysis plans |
| title_full_unstemmed | Early phase clinical trials extension to guidelines for the content of statistical analysis plans |
| title_short | Early phase clinical trials extension to guidelines for the content of statistical analysis plans |
| title_sort | early phase clinical trials extension to guidelines for the content of statistical analysis plans |
| topic | Research Methods & Reporting |
| url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8819597/ https://www.ncbi.nlm.nih.gov/pubmed/35131744 http://dx.doi.org/10.1136/bmj-2021-068177 |
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