Policy of full-scale introduced a system to be patient (clinical trials) excluded from clinical trials also available.

The Ministry of Health, Labour and Welfare has decided that for non- approved drug that has come to the final stage of development , to full-scale introduced a system patients become ( clinical trials ) excluded trials with or have had a chronic disease or were elderly are usable .
In aim to patients without treatment heavy , pathology is to be able to quickly provide a choice of a new treatment , I conduct from fiscal 2015 .
Medicine in order to obtain the approval of the market , pharmaceutical companies , must perform the clinical trial to confirm the safety and efficacy with the patient , target patients of the study is throttled by the presence or absence of chronic disease and age . There are also cases even in severe , can not participate in clinical trials of anti-cancer agent cancer patients suffer from chronic disease of heart disease , if you do not have to wait for the market and to use the study drug is not a few .
Company to perform a clinical trial to set strict conditions of the target patient and Serve a clear data , but the requirements of the patients to want to use the investigational drug is strong , the ministry has decided to introduce the new system . Under the new system , in parallel with the clinical trial of the company , doctors conduct clinical trials of another , patients who do not Kuwaware the study of companies to be able to use medicine . In practice , I submit to the country set up a clinical trial plan doctors expertise is high with the cooperation . Study drug is provided free of charge .
I will to those anti- cancer drugs with high treatment needs is assumed first , a certain safety has been confirmed company enters the final stage of development drugs .
It must be good news for patients with no treatment heavy medical conditions .



厚生労働省は、開発の最終段階にきている未承認薬について、高齢だったり持病を抱えていたりして治験（臨床試験）対象外になる患者も使える制度を本格導入する方針を決めた。
　病状が重く治療法のない患者に、新たな治療の選択肢を迅速に提供できるようにするのが狙いで、２０１５年度から実施する。
　薬が製品化の承認を得るには、製薬企業が、患者に使って安全性や効果を確かめる治験を行わなくてはならないが、治験の対象患者は年齢や持病の有無などで絞られている。重症でも、心臓病の持病を抱えるがん患者が抗がん剤の治験に参加できない例もあり、治験薬を使うには製品化を待たなければならない場合が少なくない。
　企業は明確なデータを出そうと対象患者の条件を厳しく設定して治験を行うが、治験薬を使いたいという患者の要望が強く、厚労省は新制度の導入を決めた。新制度では、企業の治験と並行して、医師が別の治験を行い、企業の治験に加われない患者も薬を使えるようにする。実施にあたっては、専門性が高い医師らが協力して治験計画を立て国に提出する。治験薬は無料で提供される。
　薬は治療ニーズの高い抗がん剤がまず想定され、企業が開発の終盤に入り一定の安全性が確認されているものにする。
　病状が重く治療法のない患者さんにとっては朗報でしょうね。