大規模なランダム化臨床試験のモニタリング:ベイジアン方法による新しいアプローチ
M K Parmar1, G O Griffiths, D J Spiegelhalter
1Cancer Division, MRC Clinical Trials Unit, 222 Euston Road, NW1 2DA, London, UK.
Lancet (London, England)
|August 15, 2001
まとめ
臨床試験のモニタリングのためのベイジアン的な方法は, p 値が早期閉鎖を示唆したかもしれないときに試験をオープンに保ち,価値のあることを証明しました. このアプローチは,データモニタリングと倫理委員会にとって,より直感的な代替案を提供します.
科学分野:
- クリニック・トライアル 臨床試験
- 医療統計 医療統計について
- 腫瘍学 腫瘍学
背景:
- データモニタリングおよび倫理委員会 (DMEC) は,通常,ランダム化臨床試験の継続的な患者登録に関する決定を導くためにp値を使用します.
- 1990年代には,肺がんと頭頸部がん患者の2つのランダム化対照試験を監視するために,ベイジアン法が採用されました.
研究 の 目的:
- ランダム化臨床試験のモニタリングにおけるベイジアン法の有用性を,従来のp値ベースのアプローチと比較して評価する.
- ベイジアンモニタリングが,試験の継続と早期終了に関する決定にどのように影響を与えたかを評価する.
主な方法:
- 臨床医の治療の有効性に関する以前の信念は,試験が開始される前に"熱狂的"と"懐疑的"の以前の分布に形式化されました.
- これらの以前の分布は,試験データで毎年更新され,DMECは,結果が懐疑論者または熱狂者を説得できるかどうかを決定しました.
主要な成果:
- DMECは,試験の治療法 (連続的高分化加速放射線療法 [CHART]) に好意的な結果が出るか,差異がないかを問わず,いずれかの試験を早期に中止するには不十分な証拠を一貫して発見しました.
- バイアスのモニタリングアプローチに基づいて,いずれの試験も早期に終了しませんでした.
- 肺がんの治験は,従来のp値に基づく停止ルールを適用していたら,早期に中止されていたかもしれません.
結論:
- 臨床試験のモニタリングに対するベイジアン的なアプローチは,実装が簡単で,DMECメンバーが容易に理解できます.
- この方法は,従来のp値ベースのモニタリング戦略よりも直感的に魅力的であると考えられています.
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