English to Romanian Medical Medical: Pharmaceuticals clinical trials

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). "