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enrichment period

Romanian translation: perioada de îmbogățire/de amplificare (a beneficiilor)

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GLOSSARY ENTRY (DERIVED FROM QUESTION BELOW)
English term or phrase:enrichment period
Romanian translation:perioada de îmbogățire/de amplificare (a beneficiilor)
Entered by: Cristina Frasineanu
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13:32 Nov 24, 2013
English to Romanian translations [PRO]
Medical - Medical: Pharmaceuticals / clinical trials
English term or phrase: enrichment period
Termenul trebuie sa poata fi folosit si in contextul "Enrichment visit"

Context: "During the Enrichment period, you will receive the study medication for 6 weeks."

"Critical features of
study design should be discussed, e.g., randomisation, blinding, choices of control treatment,
choice of patient population, unusual design features such as crossover or randomised
withdrawal designs, use of run-in periods, other methods of “enrichment”, study endpoints,
study duration, and prespecified plans for analysis of the study results."

"If only remitters to the trial drug are allowed to enter and/or are evaluated for maintenance of remission (enrichment design), the labelling will reflect this."

"The exploratory nature of this phase in the clinical development plan allows a variety of designs.
Examples are randomised placebo-controlled parallel or cross-over studies, enrichment designs,
controlled studies in patients with refractory epilepsy subjected to a pre-surgical evaluation
programme, and open add-on studies among others. "

"Of the 485 subjects in PKU-001 who received at least one dose of study drug and who had blood
phenylalanine level measurements at both Day 1 and Day 8, 96 (19.8%) were responders, as defined
for the enrichment design of the program (i.e. ≥30% reduction in blood Phenylalanine level from Day
1 to Day 8). "

"In these studies the emphasis tends to be maximization of the power of the study to detect a treatment effect. Methods of achieving this include using narrow inclusion criteria or other selection of patients considered most
likely to respond, and excluding placebo responders (enrichment design). "
Cristina Frasineanu
Local time: 18:34
(perioada de) îmbogățire
Explanation:
„Îmbogățire” ca în cazul uraniului. Preselecție.
As e citi II. BACKGROUND din Enrichment Strategies for Clinical Trials to
Support Approval of Human Drugs and
Biological Products - adresa web mai jos
Nu e vorba de a adăuga elemente noi ci de a le selecta numai pe cele adecvate, populația de studiu este restrânsă, nu lărgită.

--------------------------------------------------
Note added at 1 day23 hrs (2013-11-26 12:46:40 GMT)
--------------------------------------------------

Tocmai, selecția nu se face ca să beneficieze cât mai mulți ci se selectează cei despre care se consideră că vor beneficia cel mai mult.
Enrichment is directed at improving the ability of a study to detect a drug’s effectiveness; similar strategies can be used in safety assessments.
Selected response from:

Tudor Soiman
Local time: 18:34
Grading comment
Multumesc!
4 KudoZ points were awarded for this answer

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Summary of answers provided
4(perioada de) îmbogățireTudor Soiman
2perioada de selectieAndreea10
Summary of reference entries provided
Mihaela Petrican

Discussion entries: 2





  

Answers


23 hrs   confidence: Answerer confidence 2/5Answerer confidence 2/5
perioada de selectie


Explanation:
- eu asa am tradus;apoi cel care mi-a verificat traducerea a modificat cu perioada de imbogatire (sincer nu mi se pare in regula). E o varianta :)

Andreea10
Local time: 18:34
Specializes in field
Native speaker of: Native in RomanianRomanian
Notes to answerer
Asker: Am "screening" pentru perioada de selectare. Cred ca este vorba mai mult de o perioada de amplificare a beneficiilor/eficacitatii, adica nu este doar selectia, ci dupa selectie, un fel de a doua selectie, dintre cei selectati prima oara, sa ii caute pe cei care ar raspunde cu mai mare siguranta la tratament. Deocamdata i-am zis perioada de amplificare a beneficiilor (ca daca i-as zice perioada de crestere a numarului persoanelor care ar beneficia de tratament deja ar fi definitie, nu termen). Ma gandesc daca sa las doar "perioada de amplificare" - ca si mie imi suna "imbogatire" ciudat.

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1 day22 hrs   confidence: Answerer confidence 4/5Answerer confidence 4/5
(perioada de) îmbogățire


Explanation:
„Îmbogățire” ca în cazul uraniului. Preselecție.
As e citi II. BACKGROUND din Enrichment Strategies for Clinical Trials to
Support Approval of Human Drugs and
Biological Products - adresa web mai jos
Nu e vorba de a adăuga elemente noi ci de a le selecta numai pe cele adecvate, populația de studiu este restrânsă, nu lărgită.

--------------------------------------------------
Note added at 1 day23 hrs (2013-11-26 12:46:40 GMT)
--------------------------------------------------

Tocmai, selecția nu se face ca să beneficieze cât mai mulți ci se selectează cei despre care se consideră că vor beneficia cel mai mult.
Enrichment is directed at improving the ability of a study to detect a drug’s effectiveness; similar strategies can be used in safety assessments.


    Reference: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulat...
Tudor Soiman
Local time: 18:34
Works in field
Native speaker of: Native in RomanianRomanian
PRO pts in category: 4
Grading comment
Multumesc!
Notes to answerer
Asker: Multumesc. Nici eu nu am spus ca este este marita populatia de studiu, ci ca selectarea se face in asa fel incat sa beneficieze cat mai multe persoane din populatia selectata.

Asker: Ok, sa beneficieze cat mai multe persoane dintre cei selectati in mod special pentru a avea beneficii.

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Reference comments


1 day7 hrs
Reference

Reference information:
Enrichment: Treatments are often only tolerated by or are only efficacious for a subset
of the population. To avoid problems associated with treatment discontinuation, and to
test a treatment on the subpopulation that can most benefit from it, it can be advantageous
to determine whether a potential trial participant is a member of the subpopulation that
can either tolerate or benefit from a treatment. This pretesting and selection of
participants for trial participation prior to randomization into the treatment and control
arms is called enrichment, and can include: (1) selecting people with potentially
responsive disease, (2) selecting people likely to have an event whose occurrence is the
outcome of interest, (3) selecting people likely to adhere to the study protocol, and (4)
selecting people who show an early response to the test drug
http://hal.case.edu/~robrien/NAS_MissingData.pdf

De acord cu perioadă de amplificare a studiului, dar după cum se vede în referinţa de mai sus, nu este vorba de beneficii sau de eficacitate.

Pe de altă parte, să nu uităm că "îmbogăţire" are şi sensul de adăugare de noi elemente, a face să devină mai cuprinzător, mai complex...
http://dexonline.ro/definitie/îmbogăți

... în celelalte limbi romanice termenul utilizat în studii clinice este tocmai echivalentul "îmbogăţirii" ....se vede că "ciudăţenia" cuvântului ne loveşte numai pe noi... ;)

Mihaela Petrican
Italy
Specializes in field
Native speaker of: Native in RomanianRomanian
PRO pts in category: 650
Note to reference poster
Asker: Multumesc. Cred ca este totusi vorba de a beneficia cat mai multe persoane, inclusiv mai sus este vorba despre "test a treatment on the subpopulation that can most benefit from it" - de multe ori tocmai de-asta intreb pe proz, in ideea de a cadea de acord cat mai multi traducatori si sa devina cat de cat consacrat si cunoscut termenul. Adica daca ar fi mai multi de acord cu "perioada de îmbogatire", nu m-ar deranja, desigur. Pe "amplificare" tot pe acolo il gandisem - in loc de "imbogatire".

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