Michelle Reed


Thu, 25 Jun, 2015

Seriously ill patients miss out on new medicines due to approval processes

Seriously ill patients miss out on new medicines due to approval processes

Red tape and long approval processes for clinical trials mean that those that could benefit the most are missing out on taking part.

For many seriously ill patients who have tried everything, taking part in a clinical trial gives them hope that the test drugs will provide a cure. All too often though they miss out on taking part due to issues with getting the trials approved.

A study by the Leukaemia Foundation and Myeloma Australia showed that 40 per cent of the 675 blood cancer patients have tried to access new medicines that are not subsidised on the Pharmaceutical Benefits Scheme via clinical trials.

The CEO of Myeloma Australia, Steve Roach, said he wants access to be improved for patients wanting to take part in the trials, but that there are obstacles in the way.

"There's a very heavy bureaucracy around getting clinical trials up and going in Australia," Mr Roach said.

"Hospitals have to get ethics approvals, so their ethics committees have to approve each and every trial individually.”

"So any major hospital, be it Royal Prince Alfred in Sydney or the Royal Melbourne in Melbourne, may have already approved that trial and say it's a good trial to go ahead but the next hospital along the line has to get the same approval through their internal process and we think that that isn't necessary."

The Government announced in May that there would be a clinical trial registry setup to help bring patients and new medical trials together, but what Mr Roach is suggesting is a national ethics approval process.

"That would surely speed up the process and make many more hospitals likely to run the trials and therefore have them more widespread and available to more patients," he said.

Streamlining the approval process would boost a patients access to trials. Professor Ian Olver, the chair of the Australian Health Ethics Committee, said that to make 

that happen there would need to be an agreement between the Commonwealth and the states.

"What hasn't been streamlined at this stage is the sort of governance issues and the due diligence process on each of the trials in terms of the legals and insurance, each of the health units still want to do that themselves," Mr Olver said.

"But each of the states would have to agree to this to be able to make it happen."

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