topline data
Portuguese translation: dados principais / dados de destaque
| GLOSSARY ENTRY (DERIVED FROM QUESTION BELOW) | ||||||
|---|---|---|---|---|---|---|
|
| 18:47 Nov 10, 2023 |
| English to Portuguese translations [PRO] Medical - Medical: Pharmaceuticals | |||||||
|---|---|---|---|---|---|---|---|
|
| ||||||
|  Selected response from: Carolina Falcao Brazil Local time: 19:24 | ||||||
Grading comment
| |||||||
Answers
36 mins confidence: 
peer agreement (net): +1
peer agreement (net): +1resultados preliminares Explanation: Diria assim em PT(pt), espero que seja útil: top-line results top-line data Term reference: Pfizer. 'Pfizer Announces Positive Top-Line Results from Third Phase 3 Trial of Abrocitinib for Moderate to Severe Atopic Dermatitis, Which Showed Improvements in Skin Clearance, Disease Extent and Severity, and Itch.' (9.4.2021) Definition: first, preliminary results of a clinical study or trial Definition reference: COM-Terminology Coordination, based on: - European Medicines Agency (EMA). 'Assessment report. Veklury. International non-proprietary name: remdesivir' (9.4.2021). 25 June 2020 EMA/357513/2020 - European Commission. DG SANTE. Correspondence dated 12.4.2021 Term in context: Be particularly careful as to how you disclose “top line” results. Disclosure of the “top line” data is a particularly challenging situation for the company, because while it has to disclose the “top line” results from a clinical trial, it cannot yet disclose the underlying data. The company risks accusations that the “top line” summary excluded important details or overstated drug or device benefits despite technically meeting the primary endpoint. The key here is to never overstate the clinical trial outcome and product’s benefits. Consider whether “top line” data has been sufficiently analyzed to draw the general conclusion, whether these “top line” results absolutely must be disclosed to the investors at this point in time, what the precise messaging around these results should be, and what appropriate caveats regarding study conclusions need to be communicated. Context reference: Tom McDonald. Keys to Successful Disclosure of Clinical Trial Data and Milestones (9.4.2021). Westwicke pt resultados preliminares https://iate.europa.eu/search/result/1699644051084/1 |
| ||||||||||||||||||||||||||||||||||||||||
1 hr confidence:
1 hr confidence:
| |||||||||||||||||||||||||||||||||||||||||
