腫瘍学会議で発表された大規模なランダム化試験の公表の失敗に関連する要因
Monika K Krzyzanowska1, Melania Pintilie, Ian F Tannock
1Center for Outcomes and Policy Research, Department of Adult Oncology, Dana-Farber Cancer Institute, Boston, Mass, USA.
JAMA
|July 24, 2003
まとめ
多くの大規模な臨床試験は,発表から5年後に未発表のまま,非有意な結果を公表しない偏見がある. これは医療文献や患者のケアに関する意思決定に影響を及ぼします.
科学分野:
- クリニック・トライアル 臨床試験
- 腫瘍学研究に関する研究
- 出版バイアス (Publication Bias) について
背景:
- 大規模な臨床試験は,治療決定に不可欠です.
- 試験結果の非公表は,バイアスを導入し,最適でない医療選択につながる可能性があります.
研究 の 目的:
- アメリカ臨床腫瘍学会 (ASCO) の会合で提示された大規模なランダム化試験の完全な公表率を評価する.
- 非重要な発見に対する出版バイアスを定量化するために.
- 出版までの時間に影響を与える要因を特定する.
主な方法:
- 510の大規模 (>=200参加者) の第3相,ランダム化対照試験を対象とした調査で,ASCOの会合 (1989-1998) で発表された.
- 試験結果の分類は,有意 (P<=.05) または非有意 (P>.05) とする.
- 2002年11月まで,MEDLINE,EMBASE,Cochrane Registerを通じて完全な出版状況を追跡し,出版されていない場合,著者と連絡しました.
主要な成果:
- 大規模なランダム化試験の26%は,発表から5年以内に完全には公表されなかった.
- 有意な結果を持つ治験は,無意味な結果を持つ治験 (68%) よりも,より高い公表率 (81%) を示した.
- 口頭・総会でのプレゼンテーションと製薬会社のスポンサーシップは,より早い出版時間に関連していました.
結論:
- 大規模な腫瘍学試験の有意な割合は,発表から5年後に未発表のままである.
- 非有意な結果に対する出版バイアスは,大規模で大きなインパクトを持つ試験でも持続します.
- 非公開は,参加者,資金提供者,審査委員会に対する倫理的義務を損なう.
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