Predictability on the lead time percentage of the subject incorporation by the clinical trial

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  • 治験の被験者組入れに関するリードタイム率の予測について
  • チケン ノ ヒケンシャ クミイレ ニ カンスル リードタイムリツ ノ ヨソク ニ ツイテ

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Abstract

<p>Ｔhe speed-up of the clinical trial is an important issue. We, therefore, have searched the factors which influence the lead time percentage using the protocol data of the clinical trials in the past. Multi-regression analyses were performed for 18 phaseIII clinical trials of the adult patient subjects which were conducted during 5 years from 2003 until 2007. As a result, the regression equation was induced with parameters of 5 influencing factor；the lead time percentage(%) = 1.80A −1.23 B−2.16 C−0.08 D＋ E + 68.56 (A；number of inclusion criteria, B；number of exclusion criteria, C；number of laboratory tests, D；study duration(day), E；investigational product(internal/external medicine：5.45, injection：−5.45 ),Ｐ=.0005､ R２=0.81､ RMSE=8.8). By substituting the data of these 5 factors for the regression equation, the lead time percentage of the concerned clinical trial would be estimated at the time of the contract, resulting in the qualitative improvement of the clinical trial management.</p>

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