Some perspective on the current “AIIMS paediatric clinical trial deaths” story

Many media outlets and blogs are frothing over the news item about 49 babies dying in clinical trials at the All India Institute of Medical Sciences (AIIMS). However,over at the PharmHouse, Seeji provides some much-needed rationality and perspective on the story.

Why not go over there and read what he says…

My comment to his post reads: “Thank you and well done for posting a bit of rationality amongst all the media hysteria surrounding this news item.

“Some of the reports I’ve read state that the mortality rate for all patients treated at AIIMS (not just children) is 4%. Between this and your data of national infant mortality of 5-7%, the 1.2% mortality rate in this data is surprisingly good. If you extrapolate from these (very rough, I know), the expected number of deaths should have been between 165 and 290. However, I can’t imagine the mass media rushing to use a headline like “Over 100 babies saved by taking part in clinical trials”!

“The other key point that the mass media appears to have missed is that it is surely better to treat children with medicines that have been explicitly studied in other children, not simply prescribed off-label based on extrapolations from studies conducted in adults. Children’s physiologies are very different from those of adults. It is even more of a scandal than this claims to be that as much as 70% of prescriptions to children are off-label because insufficient paediatric studies have been carried out. This is a situation that the USA and the EU have started to put right with legislation over the past decade.

“It is disappointing that every other report or comment that I’ve seen on this item takes a sensationalist view rather than your more rational one.”

Contents of the July issue of CRfocus

The July issue of CRfocus has a theme of process modelling, with expert authors explaining how you can use them to make your SOPs more useful as training tools, see the “big picture” where processes or departments interact, and optimise your whole business process.

We also have plenty of survey results to look at this month: Paul Chester and Tania Worth present a survey on team morale and study performance, Samyuktha Ajay and Arun Bhatt look at skill requirements at sites in India, and Arun Acharjya discusses the results of the ICR Research Nurses survey.

Also in this issue, we interview Louise Wood, Head of Innovation and Industray R&D Relations at the Department of Health, about the ongoing changes to the NHS research environment, report on a joint conference between ICR and EMWA on ethical issues in publishing clinical trials, and we take a closer look at the Chartered Scientist designation.

You can find out how to receive your copy, or read articles online, at www.crfocus.org.