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新薬承認を少しでも早くするために

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最近の記事は、金銭誘導ばかりの記事でしたので、話題をがらりと変えてみたいと思います。

先ずは、先日6月24日の日経の記事です。

<治験、事前審査の要件緩和 厚労省、新薬承認を迅速に>

厚生労働省は医療機関が薬の効能を検証する治験(臨床試験)の規制を緩和する。

事前に必要な倫理審査について、参加するすべての医療機関に義務付けるのではなく、中核となる

研究機関が一括してできるようにする。

最近は治験を海外と連携して実施する「国際共同治験」が増えているが、日本の対応の遅さが全体

の足を引っ張る事態が問題視されていた。新薬承認を欧米並みに早め、患者が望む薬を入手しやす

い環境を整える。治験では症例数を確保するため複数の医療機関が参加する。

参加する医療機関は安全性の疑問や人権上の問題がないかなどを内部に委員会を設けて審査する

必要がある。これまでは参加するそれぞれの医療機関による審査が原則だったため、

一機関でも決定が遅れると治験全体に遅れが生じる事態を招いていた。
<日経2008.6.24>


現状、日本は、新薬の承認が大変遅いという実態があります。

医薬品が世界で初めて承認されてから日本で承認されるまでは平均約4年の遅れがあります。

その理由に

1.治験のスピードが遅い

2.治験のコストが高い ※欧米の約3倍

3.データの質に差がある

などの理由が挙げられます。

背景には、日本国内の治験実施施設が少ない、患者に「治験」を明確に伝えることができず、被験者

を確保できないなどの問題があります。

最近、施設・被験者募集会社の杜撰な管理、対応の記事を掲載してきましたが、こういった大きな問

題もあります。

新薬の承認の遅れの為に、患者が本来受けるべき治療を受けることができないことは大きな問題で

す。こういった問題を是正するには、被験者を含めた治験に関係する人、個人個人が治験に対するよ

り一層の正しい理解が新薬を1日でも早く患者へ届けることに繋がるのではないのでしょうか。

治験情報局ブログは、今後も治験業界の活性化の為、あらゆる情報を発信していきたいと思います

ので、いろいろな情報をお寄せいただければと思います。

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怪しさを感じるよ

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