テクノロジーを活用した臨床試験: 医学的な証拠の生成の変革
Guillaume Marquis-Gravel1, Matthew T Roe1, Mintu P Turakhia2,3
1Duke Clinical Research Institute, Durham, NC (G.M.-G., M.T.R., B.P.-L., E.D.P.).
Circulation
|October 22, 2019
まとめ
電子医療記録,モバイルアプリ,ウェアラブルデバイスを統合することで 臨床試験の効率が向上します しかし,これらの革新的な技術の採用には,実施の課題を克服し,規制の枠組みを確立することが不可欠です.
科学分野:
- 臨床試験
- 医療情報学
- バイオテクノロジー
背景:
- 伝統的なランダム化制御試験は 複雑さと費用が増加し 薬剤やデバイスの開発を妨げています
- 電子医療記録 (EHR),モバイルアプリケーション,ウェアラブルデバイスなどの新興技術は,臨床試験の効率と実用性を高める機会を提供します.
研究 の 目的:
- 臨床試験におけるEHR,モバイル,ウェアラブル技術の応用について検討する.
- これらの技術が試験の実行を効率化し,革新的な設計を可能にする方法を特定する.
- 実施の障壁と最適な規制監督の枠組みを決定する.
主な方法:
- 2018年10月に 多様な関係者グループを招集した.
- 臨床試験における新技術の応用について検討した.
- 潜在的利益,実施の障壁,規制の必要性を評価した.
主要な成果:
- 新しい技術は臨床試験の変革に 大きな可能性を秘めています
- 試験の構成要素を簡素化し,革新的な設計を可能にすることが重要な利点です.
- 繰り返し実施し,継続的に学習し,試行試験を行うことが必要である.
結論:
- EHRとモバイル・ウェアラブル・テクノロジーの統合は 臨床試験の改善に大きく貢献します
- 実施の課題に対処し,明確な規制の経路を確立することが不可欠です.
- これらの進歩を日常的な臨床試験に統合するために,段階的,学習に基づくアプローチが推奨されます.
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