国立がん研究所が主催する臨床試験における治療費の増加
Dana P Goldman1, Sandra H Berry, Mary S McCabe
1RAND Health, 1700 Main St, Santa Monica, CA 90407-2138, USA. Dana_Goldman@rand.org
JAMA
|June 12, 2003
まとめ
がん患者の臨床試験への参加は,非参加者より平均6.5%高い控えめな追加の直接ケア費用を負う. これらの費用は,初期段階の試験および死亡した患者の場合よりも高かった.
科学分野:
- 腫瘍学 腫瘍学
- 健康経済学 医療経済学
- クリニック・リサーチ 臨床研究
背景:
- 患者のケア費用の増加に関する懸念は,しばしば臨床試験の登録を妨げます.
- がん臨床試験におけるこれらのコストの懸念を裏付ける証拠は限られている.
研究 の 目的:
- 国立がん研究所 (NCI) が主催する臨床試験におけるがん患者に対する追加の直接的な患者ケア費用を評価する.
- 試験段階,治療の種類,米国の介護施設の費用を比較する.
主な方法:
- NCIが後援した臨床試験における932人のがん患者の経費を遡及的に分析し,非参加者の696人と比較した.
- 医療記録,アンケート,メディケアの請求を介して収集されたデータは,米国の83の機関から収集されました.
- 管理費と研究費を除いて,直接的な治療費に焦点を当てた.
主要な成果:
- 調整された直接ケア費用は,試験参加者の場合,約2.5年間にわたって6.5%高かった (35,418ドル対33,248ドル).
- 増加コストは,第3相 (3.5%) と比較して,初期段階 (1/2) 試験 (12.8%) で高かった.
- 死亡した非参加者と比較して,死亡した試験参加者 (17.9%) の費用は著しく高かった.
結論:
- NCIが後援する臨床試験のがん患者には,約6.5%高い直接治療費用がかかります.
- 1999年のNCI試験の推定総インクリメンタルコストは1600万ドルでした.
- 追加費用は,初期段階の臨床試験と死亡した患者でより高く,オープンな払い戻し政策の影響を最小限にすることを示唆しています.
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