Dec 2, 2023 15:15
5 mos ago
35 viewers *
English term
topline results
English to Spanish
Medical
Medical: Pharmaceuticals
US SPANISH
Part of a press release about the approval of a new medicine.
----Topline results were shared with the FDA---
The "topline results" refer to the results of a clinical trial.
I found this English definition, but I am looking for a more-or-less accepted Spanish translation:
In the clinical arena, Top-line Results (regardless of the stage of the trial or the phase of the trial) speak to the statistical significance of the trial results coming out of the subject population. Pharma often cites Top-line Results as the basis for its decision to terminate a trial or to continue a trial.
I am tempted to use "resultados preliminares."
----Topline results were shared with the FDA---
The "topline results" refer to the results of a clinical trial.
I found this English definition, but I am looking for a more-or-less accepted Spanish translation:
In the clinical arena, Top-line Results (regardless of the stage of the trial or the phase of the trial) speak to the statistical significance of the trial results coming out of the subject population. Pharma often cites Top-line Results as the basis for its decision to terminate a trial or to continue a trial.
I am tempted to use "resultados preliminares."
Proposed translations
(Spanish)
3 | informe de resultados | slothm |
4 +2 | resultados preliminares | Laura Mico |
5 +1 | resultados principales | Edel Subiros Garcia |
Proposed translations
2 days 9 hrs
Selected
informe de resultados
La aprobación de un fármaco por la FDA debe pasar por cuatro fases.
Cada fase debe tener un informe de resultados para poder proseguir a la siguiente fase o finalizar la investigación. El informe de resultados tiene un formato estadístico que lo respalda o rechaza.
https://www.etoro.com/es/markets/6185.hk
Se espera la publicación del informe de resultados del 3T 2023 de $6185.HK ... La empresa logró la fase tres de pruebas clínicas de una vacuna para COVID ...
https://cdn.www.gob.pe/uploads/document/file/201949/198713_R...
El informe de resultados de la baciloscopía debe seguir los criterios ... SEGUNDA FASE (tres veces por semana). Rifampicina (150mg). 02. Isoniacida (150mg). 03.
Cada fase debe tener un informe de resultados para poder proseguir a la siguiente fase o finalizar la investigación. El informe de resultados tiene un formato estadístico que lo respalda o rechaza.
https://www.etoro.com/es/markets/6185.hk
Se espera la publicación del informe de resultados del 3T 2023 de $6185.HK ... La empresa logró la fase tres de pruebas clínicas de una vacuna para COVID ...
https://cdn.www.gob.pe/uploads/document/file/201949/198713_R...
El informe de resultados de la baciloscopía debe seguir los criterios ... SEGUNDA FASE (tres veces por semana). Rifampicina (150mg). 02. Isoniacida (150mg). 03.
4 KudoZ points awarded for this answer.
Comment: "Thank you very much. I ended up using "resultados preliminares@ because I had to deliver the translation and had no other suitable options, but I will keep this for reference in case it comes up again. "
+2
2 hrs
resultados preliminares
Hi George, I agree with your temptation.
According to Libro Rojo:
1. resultados principales, resultados más destacados, resultados más importantes (de un ensayo clínico).
Contexto (EN): ►Insmed plans to present detailed study results at an upcoming medical meeting. The top-line results will be further discussed on Insmed's upcoming fourth quarter and year-end 2019 earnings call [Insmed website]. ►top-line preliminary results .
2 resultados preliminares (de un ensayo clínico recientemente finalizado).
Contexto (EN): ►positive top-line results of a study, positive preliminary results from a study .
According to Libro Rojo:
1. resultados principales, resultados más destacados, resultados más importantes (de un ensayo clínico).
Contexto (EN): ►Insmed plans to present detailed study results at an upcoming medical meeting. The top-line results will be further discussed on Insmed's upcoming fourth quarter and year-end 2019 earnings call [Insmed website]. ►top-line preliminary results .
2 resultados preliminares (de un ensayo clínico recientemente finalizado).
Contexto (EN): ►positive top-line results of a study, positive preliminary results from a study .
+1
18 hrs
resultados principales
I don't think that "preliminares" are the best choice if the subject is the analysis because it means before something occurs, and the results are already been obtained from a finished study or experiment. As statistical results of some process already done, this results should be treated as "principales resultados/resultados principales". If the context is about a row of experiments and studies that are a part of a bigger process that already have planned further steps it could be "preliminar" as in sports, "preliminar" is like play-off.
Peer comment(s):
agree |
Adrian MM.
: 'Top-line Results are the outcomes of the analyses (....) that are the output of a statistical analysis – whether that analysis is based on *preliminary data or final* data.' So IATE is careless+wrong: https://iate.europa.eu/search/result/1701619719430/1
7 hrs
|
Reference comments
3 days 2 hrs
Reference:
see
https://www.lawinsider.com/dictionary/top-line-data
Top-Line Data means, with respect to a Clinical Trial, a summary of demographic data, the data for the primary endpoint(s), the data for any secondary endpoint(s), if such secondary endpoint(s) are applicable, and a summary of safety data, in each case which are based on an unblinded, locked database and wherein all data are collected in a 21 CFR 11 validated database with a complete audit trail.
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Note added at 3 dni 2 godz. (2023-12-05 18:14:33 GMT)
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https://health.ec.europa.eu/system/files/2020-02/2017_01_26_...
Topline results: Simple description of the result of the primary endpoint. • Safety: overall statement about the the safety findings in the study.
Top-Line Data means, with respect to a Clinical Trial, a summary of demographic data, the data for the primary endpoint(s), the data for any secondary endpoint(s), if such secondary endpoint(s) are applicable, and a summary of safety data, in each case which are based on an unblinded, locked database and wherein all data are collected in a 21 CFR 11 validated database with a complete audit trail.
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Note added at 3 dni 2 godz. (2023-12-05 18:14:33 GMT)
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https://health.ec.europa.eu/system/files/2020-02/2017_01_26_...
Topline results: Simple description of the result of the primary endpoint. • Safety: overall statement about the the safety findings in the study.
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