Glossary entry

English term or phrase:

per local review

French translation:

évaluation locale

Added to glossary by NikkoTh
Nov 11, 2020 09:18
3 yrs ago
30 viewers *
English term

per local review

English to French Science Medical (general)
Product X Intra-patient Dose Escalation (IPDE) Following Disease Progression Provides Clinically Meaningful Progression-Free Survival (PFS) in Gastrointestinal Stromal Tumor (GIST) in Phase 1 Study
Patients may dose escalate from Product X 150 mg QD to Product X 150 mg BID after disease progression*
Escalation and Expansion with GIST Patients
Product X 150 mg QD (28 day cycles)
N = 142
Disease progression per local review
Intra-Patient Dose Escalation (IPDE) to Product X 150 mg BID
N = 67
Efficacy Endpoint
PFS (per RECIST v1.1 based on local review)*
PFS 1:
Progression-free survival on Product X 150 mg QD defined as Cycle 1, Day 1 to progression
Change log

Nov 11, 2020 09:18: changed "Kudoz queue" from "In queue" to "Public"

Proposed translations

+2
4 hrs
Selected

évaluation locale

autre possibilité

--------------------------------------------------
Note added at 4 heures (2020-11-11 14:02:11 GMT)
--------------------------------------------------

par une évaluation locale
Peer comment(s):

agree Lionel-N
1 hr
Merci Lionel
agree Drmanu49
4 hrs
Merci Drmanu
Something went wrong...
4 KudoZ points awarded for this answer.
1 hr

par examen local


As far as I understand, in clinical trials there can be central review (for ex. blinded independent central review, BICR) or local review (by the site investigator). This study is in the second situation.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2654812/

[...] The US Food and Drug Administration has suggested censoring such cases; however, this is problematic. This type of censoring will be informative—patients who progress according to local review (but not according to central review) will be more likely to progress by the next scheduled scan than patients who have not been determined to progress by local review.

--------------------------------------------------
Note added at 1 hr (2020-11-11 10:27:24 GMT)
--------------------------------------------------

In French:
https://www.kusajili.fr/Trial/Is-7g6-7rESlRuC9yhMHvA$etude-nct03693170-etude-de-phase-2-evaluant-lefficacite-et-la-securite-de-lencorafenib-associe-a-du-binimetinib-et-a-du-cetuxim

[...] Évaluer le temps de réponse par un examen local et central. Évaluer la survie sans progression par un examen local et central.

--------------------------------------------------
Note added at 1 hr (2020-11-11 10:34:58 GMT)
--------------------------------------------------

> In your context - it seems this is part of a list or a table of results, correct? So you may want something more concise and factual, rather than describing a process:
Progression de la maladie selon examen local
Something went wrong...
Term search
  • All of ProZ.com
  • Term search
  • Jobs
  • Forums
  • Multiple search