controller

Italian translation: terapia di controllo // soluzione/opzione terapeutica

GLOSSARY ENTRY (DERIVED FROM QUESTION BELOW)
English term or phrase:controller
Italian translation:terapia di controllo // soluzione/opzione terapeutica
Entered by: Chiara Gavasso

19:28 Jan 11, 2018
English to Italian translations [PRO]
Medical - Medical: Pharmaceuticals / clinical study, biosimilars
English term or phrase: controller
"When a developer of a novel drug applies for a new indication, it has to show that it does something clinically different in a disease state.
That means the developer has to conduct a superiority study compared with the current standard of care.
On the contrary, the aim of a biosimilar trial is to show no clinically meaningful differences, and that is called an “equivalence study.”
Now what are we looking for? We are looking for the most sensitive population to show a clinically meaningful difference.
Remember, many of these drugs have several indications.
The sensitivity of the indication is the difference between the outcomes for the patient, using the novel targeted therapy, and what was the previous **controller**.
In some conditions, a biologic drug makes a small but clinically important difference."

Consigli su come tradurre quel "controller"?
Chiara Gavasso
Spain
Local time: 08:47
terapia di controllo // soluzione/opzione terapeutica
Explanation:
Letteralmente è il farmaco che "controlla", cioè contrasta la patologia in questione. Da non confondere con il "controllo" che è il termine di paragone di uno studio clinico, generalmente rappresentato da un placebo.

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Note added at 10 giorni (2018-01-22 16:46:22 GMT) Post-grading
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Grazie mille a Te, Chiara. Buon lavoro e buona serata.
Selected response from:

Gaetano Silvestri Campagnano
Italy
Local time: 08:47
Grading comment
Grazie, Gaetano
4 KudoZ points were awarded for this answer



Summary of answers provided
4 +2terapia di controllo // soluzione/opzione terapeutica
Gaetano Silvestri Campagnano


  

Answers


26 mins   confidence: Answerer confidence 4/5Answerer confidence 4/5 peer agreement (net): +2
terapia di controllo // soluzione/opzione terapeutica


Explanation:
Letteralmente è il farmaco che "controlla", cioè contrasta la patologia in questione. Da non confondere con il "controllo" che è il termine di paragone di uno studio clinico, generalmente rappresentato da un placebo.

--------------------------------------------------
Note added at 10 giorni (2018-01-22 16:46:22 GMT) Post-grading
--------------------------------------------------

Grazie mille a Te, Chiara. Buon lavoro e buona serata.

Gaetano Silvestri Campagnano
Italy
Local time: 08:47
Native speaker of: Native in ItalianItalian
PRO pts in category: 672
Grading comment
Grazie, Gaetano

Peer comments on this answer (and responses from the answerer)
agree  Cinzia Pasqualino
3 days 19 hrs
  -> Grazie mille Cinzia

agree  Silvia Renghi
8 days
  -> Grazie mille Silvia
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