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|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). "
|(perioada de) îmbogățire|
„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:
Local time: 18:34
4 KudoZ points were awarded for this answer
|Summary of reference entries provided|
1 day22 hrs confidence: Return to KudoZ list
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
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...
... în celelalte limbi romanice termenul utilizat în studii clinice este tocmai echivalentul "îmbogăţirii" ....se vede că "ciudăţenia" cuvântului ne loveşte numai pe noi... ;)
|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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