Hospital in Rennes, France (file photo)



 A clinical trial of a new drug in France has left one person brain-dead and another five people in hospital, the health minister says.
The oral trial was being conducted by a private laboratory in the north-western city of Rennes, Marisol Touraine said.
The trial has been suspended and the firm is recalling the volunteers. It is unclear how many people are involved.
Media reports that the drug is a cannabis-based painkiller have been denied by the health ministry.

The Paris prosecutor's office said an investigation had been opened.
The drug was taken in a licensed laboratory, the ministry said in a statement (in French).
Ms Touraine, who was heading for Rennes on Friday, pledged to "get to the bottom... of this tragic accident".
The first people to fall ill were taken into hospital earlier this week, French media say.
The study was a Phase I clinical trial, in which healthy volunteers take the medication to evaluate the safety of its use, the ministry said.

Clinical trials

Trials typically have three phases to assess a new medicine for safety and effectiveness
  • Phase I tests for safety. A small number of people, sometimes healthy, and sometimes with a medical condition, are given a tiny dose of the drug under careful supervision, not to test if the drug works, but in order to check for any side effects
  • Phase II sees the drug given to people who have a medical condition to see if it does indeed help them
  • Phase III trials are only for medicines or devices that have already passed the first two stages, and involve them being compared to existing treatments or a placebo. The trials often last a year or more, involving several thousand patients
Has drug trial safety improved?
German medics challenge new EU clinical drug trials

Before any new medicine can be given to patients, detailed information about how it works and how safe it is must be collected.
Clinical trials are the key to getting that data - and without volunteers to take part in the trials, there would be no new treatments for serious diseases such as cancer, multiple sclerosis and arthritis.
New EU regulations to speed up clinical drug trials and streamline testing procedures across the 27-nation bloc are due to take effect in May.


BBC.
YEMI.

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My name is Ademola Babatunde,the former Student Union President of Polytechnic of Ibadan. I have created this blog to give you top class news on politics. Enjoy and God bless

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