"ダブルブラインド"制御された臨床試験で使用された薬剤の質に一致する
Lancet (London, England)
|February 14, 1976
まとめ
臨床試験の準備品の評価は,重要なマッチング問題を明らかにしました. 多くの薬剤は,色や味によって区別され,研究の完全性と観察者の信頼性に影響を与えました.
科学分野:
- クリニック・トライアル 臨床試験
- 医薬品科学 医薬品科学とは
- 研究方法論 研究方法論
背景:
- ダブルブラインド制御臨床試験は,偏見のない結果を確実にするために,区別がつかない製剤に依存しています.
- このような試験で使用された薬剤のマッチングの質を評価することは,データの有効性にとって極めて重要です.
研究 の 目的:
- ダブルブラインド制御臨床試験で使用された製剤のマッチング品質を評価する.
- ペアリングされたエージェントを区別する特定の特徴を特定する.
- 製剤の違いの観察者検出の一貫性を評価する.
主な方法:
- 4人のオブザーバーからなるパネルは,臨床試験から22組の薬剤を評価した.
- 観察者は,それらを区別できる特徴の準備を考察した.
- 色の違いや味の違いに特に注意を払いました.
主要な成果:
- 22組のペアのうち,5組は絶好のマッチであり,7組はすべての観察者によって検出された明らかな違いを示した.
- クロスオーバー研究における準備は,一貫してよく一致しなかった.
- 色の違いが最も容易に検出され,味が次いでありました.
- 差異を検出する観察者の能力は大きく変化し,ある観察者が他の観察者よりも3倍成功しました.
結論:
- ダブルブラインド試験における製剤の有意な割合は,区別可能な特徴を示し,研究有効性を潜在的に損なう可能性があります.
- 色と味は,調理品を区別する重要な要因です.
- 標準化された観察者訓練とより厳格な準備マッチングプロトコルは,臨床試験のために推奨されます.
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