This article is from the source 'bbc' and was first published or seen on . It last changed over 40 days ago and won't be checked again for changes.
You can find the current article at its original source at http://www.bbc.co.uk/news/world-europe-35320895
The article has changed 12 times. There is an RSS feed of changes available.
| Version 5 | Version 6 |
|---|---|
| France clinical trial leaves one brain-dead and others unwell | |
| (about 1 hour later) | |
| A clinical trial of a new drug in France has left one person brain-dead and another five people in hospital, in a serious condition. | A clinical trial of a new drug in France has left one person brain-dead and another five people in hospital, in a serious condition. |
| The oral trial was conducted by a private laboratory in the western city of Rennes. | The oral trial was conducted by a private laboratory in the western city of Rennes. |
| The trial has been suspended and the firm is recalling the volunteers. It is unclear how many people are involved. | 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. | 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 Paris prosecutor's office said an investigation had been opened. |
| Health Minister Marisol Touraine, who was heading for Rennes on Friday, pledged to "get to the bottom... of this tragic accident". | Health Minister Marisol Touraine, who was heading for Rennes on Friday, pledged to "get to the bottom... of this tragic accident". |
| The trial was conducted by Biotrial, a French-based company with an international reputation which has carried out thousands of trials since it was set up in 1989. | The trial was conducted by Biotrial, a French-based company with an international reputation which has carried out thousands of trials since it was set up in 1989. |
| According to the health ministry, the accident occurred on Thursday. | According to the health ministry, the accident occurred on Thursday. |
| The worst of those affected is brain dead, it said, while the other five are described as being in a critical neurological condition. | The worst of those affected is brain dead, it said, while the other five are described as being in a critical neurological condition. |
| 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. | 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 | Clinical trials |
| Trials typically have three phases to assess a new medicine for safety and effectiveness | Trials typically have three phases to assess a new medicine for safety and effectiveness |
| Has drug trial safety improved? | Has drug trial safety improved? |
| German medics challenge new EU clinical drug trials | 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. | 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. | 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. |
| Every year around the world thousands of people take part in clinical trials but incidents like this are very rare, the BBC's Hugh Schofield reports from Paris. | Every year around the world thousands of people take part in clinical trials but incidents like this are very rare, the BBC's Hugh Schofield reports from Paris. |
| New EU regulations to speed up clinical drug trials and streamline testing procedures across the 28-nation bloc are due to take effect in May. | New EU regulations to speed up clinical drug trials and streamline testing procedures across the 28-nation bloc are due to take effect in May. |