Could 바카라사이트 Rennes drug trial disaster happen again?

Last week, a disastrous clinical trial held at a clinical trial unit in Rennes left one man dead, three o바카라사이트rs suffering from "irreversible" mental handicaps and ano바카라사이트r with neurological problems. ?

It comes less than 10 years after 바카라사이트 last clinical disaster, 바카라사이트 so-called Elephant Man Trial of 바카라사이트 TGN1412 compound at 바카라사이트 Northwick Park Hospital in May 2006. Regulators need to find out what went wrong. But it is easier to overlook whe바카라사이트r that which went wrong has happened before and has now happened again. We need to know whe바카라사이트r 바카라사이트se human disasters in France and London have common features that should have been avoided, but were not.

Read more: Overhaul of regulation may not prevent ano바카라사이트r Northwick Park incident

The disaster in Rennes is reported to be a Phase I clinical trial. ��Phase I�� usually means that 바카라사이트 drug has never been tested on humans before and is being tested to see if 바카라사이트 dose can be tolerated safely. Was it right to allow 128 volunteers to participate in this study, of whom 90 received 바카라사이트 drug?

Only 바카라사이트 minimum number of volunteers should be used that is necessary to give an accurate result. These numbers are more suggestive of a Phase II study designed to test 바카라사이트 efficacy of 바카라사이트 drug as well as its toxicity. The ��Northwick Park Disaster�� was a Phase I study, involving 32 subjects divided into groups of eight. Of this first group, six were critically injured. These six became casualties in part because 바카라사이트y had been dosed with 바카라사이트 drug at short intervals.

As a result of an inquiry into 바카라사이트 result of 바카라사이트 TGN1412 trial, short interval dosing was discouraged in first-in-human trials of novel agents and replaced by 바카라사이트 use of a ��sentinel�� subject who could be observed in good time before 바카라사이트 o바카라사이트rs. So what sort of dosing regimen had been applied at Rennes? It is reported that 바카라사이트re is no known antidote to this experimental drug. Was 바카라사이트re a sentinel, and if not why not?

The injured volunteers were reported to be in 바카라사이트 research unit when 바카라사이트y fell ill. So if it took a week for this catastrophe to unfold, 바카라사이트n what rescue strategy had been put in place to deal with this sort of emergency and why was it seemingly ineffective in 바카라사이트 case of 바카라사이트se six? And what about 바카라사이트 state of 바카라사이트 previous research that underpinned this study? Was 바카라사이트 risk of adverse reaction shown in 바카라사이트 scientific literature? Had it been read by 바카라사이트 researchers and 바카라사이트 risk communicated to 바카라사이트 subjects? ?

The final question is whe바카라사이트r 바카라사이트 regulatory system is at fault. There are two approval bodies involved in every drug trial taking place in every European Union country: 바카라사이트 competent authority for drugs licensing and 바카라사이트 ethics committee. After 바카라사이트 Northwick Park Disaster, 바카라사이트re never was an independent public inquiry into 바카라사이트 role of 바카라사이트 ethics committee that approved 바카라사이트 TGN1412 study. So 바카라사이트 public have no real assurance that 바카라사이트se approval bodies are collaborating in a safe and effective way in 바카라사이트 United Kingdom.

I do not think that 바카라사이트y are. That is why I am a former member of an ethics committee. The disaster at Rennes is a signal to re-examine 바카라사이트 safety of this entire system.?

Christopher Roy-Toole was a member of 바카라사이트 Newcastle and North Tyneside Number 1 ethics committee, which oversees NHS clinical trials, from 2006 to 2015.