Clinical trial concern

The health of patients who take part in treatment trials may be put in danger by Government changes to ethics committees, a group of academics says.

After a health select committee inquiry last year into making New Zealand more attractive to companies wanting to run clinical trials, the Government said it would streamline the trial application process, making it simpler and more internationally competitive.

Health Minister Tony Ryall said on Sunday night that the safety of participants remained paramount.

The changes include reducing the number and size of the regional health and disability ethics committees, and restricting some trials, based on their expected level of risk, to consideration solely by a committee chairman.

The head of the University of Otago's bioethics centre, Prof Gareth Jones, said in a letter to The New Zealand Herald that he and Profs Donald Evans, John McCall and Charlotte Paul (Otago) and Prof Tim Dare (Auckland University), believed the changes would "undermine the current safeguards for research participants".

"The reduction in the number of ethics committees from seven to four will significantly increase the workload of each committee. To meet that workload, the committees are expected to reduce the level of scrutiny of clinical trials, provide expedited review by the chair, and not review some research.

" ... many studies will not receive full ethical review and some will not be reviewed at all."

Some trials considered low risk would receive only the "expedited review" by the chairman, which was sometimes hazardous.

Prof Jones cited the example of a trial of probiotic use in serious illness as one that would not, under the new system, require full review.

"Yet one such trial published in the Lancet in 2008 reported on a case in the Netherlands where a major excess of deaths in the probiotic group and subsequent investigation showed that the monitoring arrangements for adverse events were insufficient; hence some deaths may have been avoidable."

Prof Paul on Sunday said there had been some problems with the ethics committees, but they had been resolved and the new scheme, to be implemented by midyear, was a backward step.

"I can't see how you can - you couldn't - distinguish high and low risk trials. All trials should go for full review," said Prof Paul, who was a medical adviser to the Cartwright inquiry in the 1980s into the "unfortunate experiment" at National Women's Hospital.

Prof Paul said the group of academics was writing to the minister, appealing for a rethink on the ethics committee changes.

But Mr Ryall said, "We are providing a more streamlined process without affecting quality ... we are confident that quality review will not be adversely affected and that participant safety remains paramount."

The changes
- Health and disability ethics committees reduced from seven to four.
- Committees shrink to eight members, from 12.
- Some clinical trial applications to be given priority, based on risk level.



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