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臨床試験中および外で治療されたがん患者のアウトカムの比較:概念的枠組みと構造的レビュー
Jeffrey M Peppercorn1, Jane C Weeks, E Francis Cook
1Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA 02115, USA.
Lancet (London, England)
|January 31, 2004
まとめ
臨床試験におけるがん患者がより良い結果を得ているという信念には,十分な証拠がない. "試験効果"が将来の治療法を改善するだけでなく,実際に患者に利益をもたらすかどうかを確認するために,より厳格な研究が必要です.
科学分野:
- 腫瘍学 腫瘍学
- 臨床研究方法論 臨床研究方法論
- バイオ統計学 バイオ統計学
背景:
- 多くの腫瘍学者は,臨床試験の癌患者は,非試験患者と比較して優れた結果を経験すると仮定しています.
- この研究は,宇宙の存在を支持する経験的証拠を批判的に検討しています.
- 試行錯誤効果は試行錯誤効果である
- がん治療において.
研究 の 目的:
- 理論を支持する証拠の妥当性と一般化性を評価する.
- 試行錯誤効果は試行錯誤効果である
- 腫瘍学における患者のアウトカムについて.
主な方法:
- 臨床試験と非臨床試験の患者コホートを比較するための概念的枠組みが開発されました.
- 広範な文献検索により,研究結果を比較し,その方法論を批判的に評価した研究が見つかりました.
- 混同要因を制御し,適切な対照群を使用した研究に焦点を当てました.
主要な成果:
- 24 件の論文から 26 件の比較が分析され,21 件の論文は遡及設計を用いた.
- 14件の比較により,治験患者の改善が示唆されましたが,方法論的な限界は一般的でした.
- 試験外の対照群を適格な患者に限定した研究はわずか8件で,3件が試験群でより良い結果を示した.
結論:
- 現在,十分な信頼性の高いデータが不足しているため,エイズウイルスの存在を裏付けている.
- 試行錯誤効果は試行錯誤効果である
- がん患者のアウトカムを改善する.
- 患者は依然として,将来のがん治療の進歩における確立された役割のために,臨床試験に参加するよう奨励されるべきです.
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