MCRI deal with Quintiles to triple clinical trial activity

The Murdoch Children's Research Institute (MCRI) in Melbourne has entered into an alliance with international clinical trials organisation Quintiles to bring international paediatric clinical trials to the institute's clinical trials group.

Director of the unit, Assoc Prof Noel Cranswick, said the agreement between the Australian Paediatric Pharmacology Research Unit (APPRU) and Quintiles would see a tripling of clinical studies coming through the unit.

While similar to an adult clinical trials unit, the APPRU is designed to be both child friendly and parent friendly, with efforts made to minimise trauma experienced by children taking parts in trials.

The unit was set up at the MCRI and the Royal Children's Hospital in Melbourne in 2000 to be a centre of excellence for paediatric clinical trials and was funded using part of an AUD$4.9 million STI infrastructure grant provided to the MCRI by the Victorian state government.

"The Murdoch Children's Research Institute is extremely pleased at this outcome of the STI initiative from the Victorian government," said MCRI director Prof Bob Williamson.

According to Cranswick, many drugs are not tested on children before they are approved for sale. "80 per cent of medicines registered in Australia are not registered for children, although they may be used [off-label] to treat children," he said. The issue of including children in trials has been around for years, he said, with many people thinking that children were too vulnerable to test new drugs on and that testing new therapies on children was unethical.

But moves over the last decade by the US Food and Drug Administration to include children in trials has prompted the creation of 13 centres of excellence in the US to do these kinds of studies, and the APPRU was set up to provide the same kind of service in Australia.

Although the APPRU conducted 20 clinical studies last year, involving 100 children and ranging from early-phase to post-market trials, it has had difficulties in gaining the attention of big pharma, according to Cranswick. He said the agreement with Quintiles would allow the unit to participate in large international trials.

"The advantage for Quintiles is that they'll have access to a world-class site to do trials, and the advantage for us is access to trials that we wouldn't have access to otherwise," he said.

An additional perk may be that pharmaceutical companies trialling drugs in Australia may register the drugs for use in Australia sooner rather than later.

And Cranswick said he believed the alliance would raise Victoria's profile as a clinical trials site, with the possibility of more involvement in international clinical trials at both the paediatric and adult level.

MCRI director Williamson said the Quintiles alliance was a win for Australia, ensuring that Australian children would be able to participate in international clinical trials providing access to new and effective drugs.