昨日の続き（ロンドンでの第 I 相試験）

英国医薬品庁のサイトには製薬会社名、治験薬名は掲載されていませんが、マスコミの報道ではと実名が挙がっています。

治験薬は自己免疫系疾患、炎症性疾患、白血病などの薬としてドイツ、Wuerzburgの製薬会社によって開発されたモノクローナル抗体のようです。

場所はロンドン郊外の米国のCROが運営する治験専門医療機関らしい。

数々の非臨床試験（動物実験）をクリアして初めて人間（健常成人ボランティア）に投与される第I相試験での出来事。
臨床試験に参加していた８人のうち、投薬された６人全員が投与直後から苦しみ始め、多臓器不全で治療を受けたとのこと。
うち２人はかなり重篤な状態に陥ったとのこと。
８人のうち２人はプラセボを投与されていたので問題なかったらしい。

原因は調査中（捜査中）とのことだが、製薬会社やCROに落ち度がないことを期待したい。

そして、英国でどんな形で報道されているのかわからないが、臨床試験の危険性のみをあおるのは止めてほしい…。


■英国医薬品庁（MHRA：Medicines and Healthcare Products Regulatory Agency）→http://www.mhra.gov.uk

Press release: UK medicines watchdog suspends Clinical Trial Authorisation Press release Date: 14 Mar 2006 Time: 18:53 Subject: Suspension of Clinical Trial Authorisation Contact: Press Office 020 7084 3535/3564 or press.office@mhra.gsi.gov.uk Out-of-hours 07770 446 189 The Medicines and Healthcare products Regulatory Agency (MHRA) has today suspended a phase 1 clinical trial for a new product that is being developed to treat chronic inflammatory conditions and leukaemia, having been notified that six men involved in the first stages of a clinical trial have been admitted into intensive care.  Eight men took part in this stage of the clinical trial; six were given the product and two were given a placebo. The MHRA has been assured by those running the trial that nobody else has been given the product. The MHRA has also notified other European regulatory bodies.  The MHRA will be sending inspectors to an independent medical research unit on the Northwick Park hospital campus, to start investigations. The MHRA is working with North West London Strategic Health Authority, Department of Health and Metropolitan Police.   Professor Kent Woods, Chief Executive Officer at MHRA said, “Our immediate priority has been to ensure that no further patients are harmed. We will now undertake an exhaustive investigation to determine the cause and ensure all appropriate actions are taken.” Notes to Editor 1. The MHRA has suspended the Clinical Trial Authorisation (CTA) for this trial with immediate effect and is reviewing the data submitted with the application for the CTA. 2. The MHRA is the government agency responsible for ensuring that medicines and medical devices work and are acceptably safe. No product is risk-free. Underpinning all our work lie robust and fact-based judgements to ensure that the benefits to patients and the public justify the risks. We keep watch over medicines and devices, and we take any necessary action to protect the public promptly if there is a problem. We aim to make as much information as possible publicly available. Download documents:UK medicines watchdog suspends Clinical Trial Authorisation (CTA)