This question was closed without grading. Reason: No acceptable answer
Jun 14, 2013 12:04
10 yrs ago
English term
Koen Speetjens (X)
enrichment
English to Norwegian
Medical
Medical (general)
"This is a prospective, randomized, double-blind, enriched-population, placebo-controlled, multicenter study. Eligible subjects will proceed to a run-in period to optimize RAS inhibitor and diuretic doses.
Following the Run-in period, eligible subjects will enter the Enrichment Period in which all will receive atrasentan 0.75 mg per day for 6 weeks to determine their UACR.
...
For entry into the Double-Blind Treatment Period, the subject must satisfy the following criteria based on the last visit of the Enrichment Period:
• RAS inhibitor at the MTLDD for the previous 6 weeks during the Enrichment Period with no adjustments of the dose;
..."
Så studien er delt i tre: "Run-in period", "Enrichment period" og "double blind treatment period".
Det er så vidt jeg kan se ikke snakk om titrering: pasientene får den samme dosen i hele perioden. (Og ellers hadde de vel brukt "titration").
Finnes det et faguttrykk for "enrichment"?
Following the Run-in period, eligible subjects will enter the Enrichment Period in which all will receive atrasentan 0.75 mg per day for 6 weeks to determine their UACR.
...
For entry into the Double-Blind Treatment Period, the subject must satisfy the following criteria based on the last visit of the Enrichment Period:
• RAS inhibitor at the MTLDD for the previous 6 weeks during the Enrichment Period with no adjustments of the dose;
..."
Så studien er delt i tre: "Run-in period", "Enrichment period" og "double blind treatment period".
Det er så vidt jeg kan se ikke snakk om titrering: pasientene får den samme dosen i hele perioden. (Og ellers hadde de vel brukt "titration").
Finnes det et faguttrykk for "enrichment"?
Discussion
"A new clinical trial design, designated the two-way enriched design (TED), is introduced, which augments the standard randomized placebo-controlled trial with second-stage enrichment designs in placebo non-responders and drug responders. The trial is run in two stages. In the first stage, patients are randomized between drug and placebo. In the second stage, placebo non-responders are re-randomized between drug and placebo and drug responders are re-randomized between drug and placebo."
Populasjonen blir altså begrenset etter hvert som responsen vises.
Litt mer som jeg har funnet (http://www.contractpharma.com/issues/2013-03/view_fda-watch/...
"Enrichment strategies are used in product development to enhance efficiency and available data. Their use can lower development costs, reduce development times, and decrease the number of trial subjects required for evaluation. The term “enrichment,” as used in the draft guidance document, means the “prospective use of any patient characteristic to select a study population in which detection of a drug effect (if one is in fact present) is more likely than it would be in an unselected population.” Many different characteristics — demographic, historical, genetic, psychological — have been used for enrichment. The term may also refer generally to the population to be evaluated within a broader population. "
Dvs. at først finner man ut hva som er riktig dose RAS-hemmer og diuretikum. Deretter får pasientene i tillegg atrasentan i "enrichment"-perioden for å se virkningen og om det tåles. I den dobbeltblinde behandlingsperioden fortsetter halvparten (av pasientene som kan gå videre) med atrasentan og halvparten får placebo.